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06.20.2008
The FDA plans to lay heavier regulations on Big Pharma.
by Linda Marsa
For years the Food and Drug Administration has failed to adequately
monitor the pharmaceutical industry. That conclusion by a special
committee at the Institute of Medicine in a September 2006 report
titled “The Future of Drug Safety”
helped prompt a sweeping reform bill that became law last September.
The Food and Drug Administration Amendments Act of 2007 gives the FDA
the dollars and legal clout it needs to make a number of important
fixes. Its key provisions and other new initiatives include these:
• The FDA will hire 1,300 new employees, with at least 400 dedicated to drug review.
• The agency has earmarked money for the development of a network of
organizations to monitor the safety of FDA-approved drugs. Assembled
and led by the FDA, the network participants—which include health-care
insurers and providers—will have the ability to search millions of
their own database records at the agency’s request. This surveillance
system is built to identify problems, such as side effects of
pharmaceuticals and medical therapies, as they emerge.
• All clinical trials of every FDA-approved drug must be registered on an NIH Web site, with results of those trials also posted.
• The FDA can now compel companies to do more studies as warranted even after drugs are approved.
• Penalties of up to $10 million may be imposed for violations of
the new REMS (risk evaluation and mitigation strategy) provisions,
designed to manage a known or potential serious risk associated with a
drug or biological product.
• The agency can now demand more rapid changes to drug warning labels if new side effects emerge.
• Print drug ads now need to have a hotline number consumers can
call to report bad reactions. TV commercials must present side-effect
warnings in a “clear, conspicuous, and neutral manner”—a mandate the
agency is currently defining.
While these are positive steps, it may be years before they are
fully implemented, and many people question just how great their impact
will be. “Having the authority and using it wisely are two different
things,” says the chairman of the Cleveland Clinic’s department of
cardiovascular medicine, Steven Nissen, who advised Congress on the FDA overhaul. “We’ll just have to wait and see how well the FDA uses its new powers.”
Data In Drug
Promotional Brochures Can Be Inaccurate
ScienceDaily (Mar. 4, 2006) — Brochures
produced by pharmaceutical companies to promote drugs to doctors don't always
present accurate data. A study published today in the open access journal BMC
Family Practice found that three out of twenty promotional brochures studied
contained data that was different from the original study on the effects of the
drug. Although the differences were small, the authors of the study recommend
that doctors review original studies before changing their drug prescribing
behaviour based on promotional brochures. Roberto Cardarelli and colleagues
from University of North Texas Health Science Center, Texas, USA asked
physicians in five clinics to collect the promotional brochures they had
received from pharmaceutical companies. Twenty brochures representing 20
different drugs were collected from October to December 2004 and the original
corresponding studies were obtained. Two reviewers compared the content of each
brochure with the data presented in the original study.
Cardarelli et al.'s results show that for three of the brochures studied,
the data presented on the brochure differed from the results of the underlying
study. Of the 20 identified studies, 15 studies were rated as valid and 16 had
been funded by the pharmaceutical company producing the drug.
Big Pharma Spends
More On Advertising Than Research And Development, Study Finds
ScienceDaily (Jan. 7, 2008) — A new study
by two York University researchers estimates the U.S. pharmaceutical industry
spends almost twice as much on promotion as it does on research and
development, contrary to the industry’s claim.The researchers’ estimate is
based on the systematic collection of data directly from the industry and
doctors during 2004, which shows the U.S. pharmaceutical industry spent 24.4%
of the sales dollar on promotion, versus 13.4% for research and development, as
a percentage of US domestic sales of US$235.4 billion.
The research is co-authored by PhD candidate Marc-André Gagnon, who led the
study with Joel Lexchin, a long-time researcher of pharmaceutical promotion,
Toronto physician, and Associate Chair of York’s School of Health Policy &
Management in the Faculty of Health.
“In our paper, we make the case for the need for a new estimate of
promotional expenditures by the U.S. pharmaceutical industry,” says Gagnon. “We
then explain how we used proprietary databases to construct a revised estimate
and finally, we compare our results with those from other data sources to argue
in favor of changing the priorities of the industry.”
The study is important because it provides the most accurate image yet of
the promotional workings of the pharmaceutical industry, says Lexchin.
The authors examined the 2004 reports of IMS Health (IMS) and CAM Group
(CAM), two international market research companies that provide the
pharmaceutical industry with sales/marketing data and consulting services. IMS
obtains its data by surveying pharmaceutical firms, while CAM surveys doctors,
which explains important discrepancies in the data they provide.
The researchers used 2004 as the comparison year because it was the latest
year in which information was available from both organizations.
CAM reported total promotion spending by the U.S. pharmaceutical industry as
US$33.5 billion in their 2004 report, while IMS reported US$27.7 billion for
the same year. The authors observed, however, important differences in figures
according to each promotion category. By selectively using both sets of figures
provided by IMS and CAM, in order to determine the most relevant data for each
category, and adjusting for methodological differences between the ways IMS and
CAM collect data, the authors arrived at US$57.5 billion for the total amount
spent on pharmaceutical promotion in 2004. The industry spent approximately
US$61,000 in promotion per physician during 2004, according to Gagnon.
“Even our revised promotion figure for 2004 is apt to be understated, as
there are other promotion avenues that are not likely to be taken into
consideration by IMS or CAM, such as ghost-writing and off-label promotion,”
says Gagnon. “Also, seeding trials, which are designed to promote the
prescription of new drugs, may be allocated to other budget categories.”
IMS and CAM data were used for comparison purposes because data from both
are publicly available, both operate globally and are well regarded by the
pharmaceutical industry, and both break down their information by different
promotion categories. Most importantly, the two organizations use different
methods for gathering their data, allowing the researchers to triangulate on a
more accurate figure for each promotion category.
The authors focused their study on the United States because it is the only
country in which information is available for all of the major promotion
categories, and it is also the largest market for pharmaceuticals in the world,
representing approximately 43% of global sales and global promotion
expenditures.
Gagnon’s and Lexchin’s new estimate of total promotional costs is also
consistent with estimates of promotional spending by the U.S. pharmaceutical
industry from other sources they scrutinized, including reports by Consumers
International, a non-governmental organization which represents consumer groups
and agencies worldwide; Office of Technology Assessment, which extrapolated
results from the cost structure of Eli Lilly, a global pharmaceutical company;
Marcia Angell, former editor-in-chief of the New England Journal of Medicine,
who extrapolated data from Novartis Inc., a company which distinguishes
marketing from administration expenditures in its annual reports; and the
United Nations Industrial Development Organization.
As well, note the authors, the number of meetings for promotional purposes
has dramatically increased in the U.S. pharmaceutical industry, jumping from
120,000 in 1998 to 371,000 in 2004, further supporting their findings that the
U.S. pharmaceutical industry is marketing-driven.
Thus, the study’s findings supports the position that the U.S.
pharmaceutical industry is marketing-driven and challenges the perception of a
research-driven, life-saving, pharmaceutical industry, while arguing in favour
of a change in the industry’s priorities in the direction of less promotion,
according to Gagnon and Lexchin.
Their study, “The Cost of Pushing Pills: A New Estimate of Pharmaceutical
Promotion Expenditures in the United States,” appears in the January 3, 2008
issue of PLoS Medicine, an online journal published by the Public Library of
Science
Nurses As 'Soft
Targets' Of Drug Company Promotion
ScienceDaily (Feb. 9, 2008) — Nursing
education fails to prepare graduates to deal with the pharmaceutical industry's
promotional tactics, and many nurses appear to accept promotional materials
uncritically, according to an analysis of the nursing literature recently
published."The pharmaceutical industry recognizes nursing influence on
medical prescribing and identifies nurses as a marketing target," say the
authors, Annemarie Jutel (Otago Polytechnic, Dunedin, New Zealand) and David
Menkes (University of Auckland, Hamilton, New Zealand). "The industry has
had its eye on nurses and nurse practitioners for over a decade, and is heavily
invested in wooing them."
Jutel and Menkes examined the published nursing literature, to look for
papers that explored the influence of drug companies upon nurses and their
education. Of the 32 articles that they found, only 13 expressed or reported
any serious concerns about the role of the pharmaceutical industry in
influencing nursing behavior. Four articles were "clearly
industry-friendly," while 14 expressed mild concern about the
pharmaceutical industry, viewed the support of the industry as generally
favorable, or identified both the harms and benefits of the industry's
involvement in health care.
Nurses should be encouraged to re-evaluate the educational benefits of
promotional information, say the authors, "which is carefully selected,
prone to bias, and hardly likely to be as beneficial as many believe."
Rather simplistically, they say, many articles about the undue influence of
drug companies upon nurses argue that nurses simply need to be aware of the
problem, and that through such awareness nurses will be able to avoid
complicity in unethical drug promotion. "This optimistic approach belies
the fact that many nurses are not trained in critical appraisal, and appear to
understand little of the mechanisms by which marketing strategies
operate," say Jutel and Menkes.
The authors call for a three-pronged strategy to tackle drug company
promotion to nurses: train nurses to understand and manage the impact of
commercial activity; institute broad health care policies to identify and
prevent the intrusion of external commercial interests into clinical decision
making at the bedside; and conduct research that will aid nurses with the
challenges of pharmaceutical promotion.
Journal citation: Jutel A, Menkes DB (2008) Soft targets: Nurses and the
pharmaceutical industry. PLoS Med 5(2): e5. doi:10.1371/journal.pmed.0050005
June 16th, 2008
A bill that would allow pharmacies to distribute customers’ information and
provide reminder mail about their prescriptions has made it through the
California Senate and is waiting for review by the Assembly. Senate bill
1096, the Confidential of Medical Information Act (CMIA), would allow
pharmacies and third-party health information groups to contact patients by
mail to remind them to fill prescriptions, a move advocates of patient and
prescriber confidentiality worry would open the door for pharmaceutical
companies to market in even more direct and personal ways than they do now.
PostScript talked about the bill’s potential reach with New Hampshire Rep. Cindy
Rosenwald. Rosenwald, who chairs the Health, Human Services and
Elderly Affairs committee, is the sponsor of New Hampshire’s embattled
Prescription Data Privacy Act, which is currently under appeal in the U.S. 1st
Circuit Court of Appeals.
P.S: What would the passage of CA S.B. 1096 mean for patients?
C.R: I think everybody has something to gain, except the patient. The
pharmacies have something to gain, by selling the patient’s info. Second,
they have something to gain if that patient fills the Rx. I believe the
pharmaceutical industry [has something to gain], because now they know the end
end user of their products.
But many people feel that’s another form of marketing. Because it’s in
the pharmacy’s interest to have that patient fill that Rx again. There are many
reasons someone might not refill their prescription, not the least of which
they can’t afford them. You may have filled a prescription for one
medication, but it didn’t work or you didn’t tolerate it. But if you get a
letter from the pharmacy, it’s not hard to see a patient getting confused and
filling the wrong prescription, or both.
P.S: Your recent presentation at the National Legislative
Association to Reduce Drug Prices (NLARX) in Charleston, West
Virginia outlined ways the pharmaceutical industry is getting around HIPAA – is
this a case of the pharmaceutical or pharmacy industry getting around a
stronger state law?
C.R: HIPAA’s definition of marketing is too narrow. If the communication is
related to the individual’s treatment, HIPAA says it’s not marketing. To
me, that’s marketing.
States are not allowed to loosen HIPAA. What the California bill would
allow, if passed, is to break through that law, because pharma may be able to
sign a business associate agreement with pharmacies.
The business associate is obligated to follow the same laws as the
HIPAA–covered entity, but the covered entity is only liable if they knew or had
reason to know of violations. There is a huge, huge gaping loophole.
I did hear an example of that happening in New Hampshire. A woman was taking
an expensive hypertensive. She stopped filling her prescription because her
doctor had given her free samples, and three weeks later she got three letters.
One was from her insurer, one was from her pharmacy, and the third letter was
from the drug company – which really upset her.
Why is it a drug company’s responsibility to have a patient adhering to a
particular medication? It’s the responsibility of the doctor, the patient, and
maybe the insurance company. I don’t even think it’s the pharmacy’s
responsibility.
So I don’t see this as a healthcare issue, I see it as a marketing issue.
P.S: Are there characteristics of its passage that suggest this
is unique to California and might not happen the same way in say, New
Hampshire?
C.R: It looks like the California Senate wanted to allow this. I’m not
sure our data mining ban [New Hampshire’s Prescription Data Privacy Act] would
prevent that kind of activity here, if they came to us. But New Hampshire
is fiercely protective of individual privacy.
I know that [the CMIA] failed narrowly in the California Senate the first
time. And then they brought it back, with an opt out, and then it passed.
Between 1 and 3 percent of consumers will opt out. And then, I believe
there’s absolutely no control over what they will do with the information.
P.S: What does this mean for the data-mining legislation, both in
California and more widely?
C.R: I know California looked at a data-mining ban, but most of those bans
focused only on prescriber identity. The part of the [New Hampshire] law that’s
in litigation is only related to prescribers. So the patient protections
are still in force in New Hampshire.
I think if the bill becomes law, that’s not good for patients. There’s
no reason to believe the pharmaceutical companies have the patients best
interest at heart.
June 12th, 2008
Making the rounds
The Reader starts with the most continental news in the world of
pharmaceutical conflict of interest this week: the AMSA PharmFree Scorecard,
released with RxP last week, made sea-to-sea headlines and/or waves. Here’s a
handful of stories about schools who made the grade, and some that didn’t.
San Francisco Chronicle
Lawrence Journal-World
Dallas Morning News
Pittsburgh Post-Gazette (and editorial)
New Mexico Independent
Harvard Crimson
Daily
Californian
ADHDing machine
A report that three prominent Harvard child psychiatrists failed to report large sums of drug company pay under
institutional disclosure policy yanked the problem of disclosure squarely into
the spotlight. Dr. Joseph Biederman, along with colleagues Dr. Timothy Wilens
and Dr. Thomas Spencer, amended their disclosure reports after a Congressional
probe by Sen. Chuck Grassley (R-IA) found that each had significantly
underreported pharmaceutical payments, from which each made more than $1
million between 2000 and 2007. According to news reports, the amended
disclosures still don’t match pharmaceutical company records, which indicate
each of the doctors received more.
“Although many of his studies are small and often financed by drug makers,”
the New York Times writes of Biederman, “his work helped
to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of
pediatric bipolar disorder, which is characterized by severe mood swings, and a
rapid rise in the use of antipsychotic medicines in children. “
Back to the disclosure problem: Harvard, like many academic medical centers,
had a disclosure policy in place, which relies on the honor system for faculty
to report their own industry earnings. A system that didn’t work right
this time, and which makes the case, as these Boston Globe and New York Times editorials do, for the Physician Payments Sunshine Act. The Sunshine Act,
which is still under construction after a series of compromises with
pharmaceutical companies reshaped the bill in May, would eliminate the problem
of faulty and voluntary self-reporting by relying on mandatory company
reporting –it was the company data, after all, that turned Grassley on to the
discrepancies in the first place.
The long view
And since it’s always good to see something from a distance, we made the
small hop across the pond (well, virtually) and to take a gander
at the British Medical Journal’s account of the bill.
June 3rd, 2008
Grades are up at the AMSA
PharmFree Scorecard, which assessed the conflict of interest policies of
all 150 medical schools in the U.S. To develop the scorecard, the American
Medical Student Association teamed up with RxP, which has been working to help
schools strengthen their policies on limiting pharmaceutical marketing on
campus.
Like your micro-econ class, it was pretty hard to get an A – only 7 schools
did, along with 14 Bs, also a tough get, since the grades were tabulated on 11
areas of industry influence as diverse as gifts, purchasing and formulary, site
access for industry vendors, and continuing medical education.
60 schools (40%) received a grade of F. This includes 15 that either
submitted policies graded as F or indicated they had no relevant policies, as
well as 16 schools that declined to submit policies and 29 that did not respond
to repeated attempts at follow-up.
But unlike those pesky online grades posted after your professor was already
well on his way to Provence with the kids, the AMSA interactive website allows
you to sort by state, city, and strength of individual domain, plus read
excerpts of actual policies that took interesting approaches and read model
language for schools looking to raise their scores with some extra credit.
Plus, check out the pie chart and brush up on your geography with a spiffy map
of the U.S.
And yes, all you primary junkies, Puerto Rico’s on there.
May 28th, 2008
A couple of weeks ago, GlaxoSmithKline Chief Chris Viehbacher tried out the
bully pulpit on Massachusetts lawmakers considering a gift ban for
physicians. Too early to tell, but it may have done more harm than good. So now pharma
companies are trying a different tactic – have the caterers plead their case
for them.
The caterers who make all those physician lunches certainly have a horse in
this race - Kevin Abt, Founder of RestaurantstoYou.com, a corporate catering
service in Stoughton, Mass., estimates that pharmaceutical reps drop $40
million on food in for docs in the state every year. Hardly chump change.
And because of this, he’s asking Massachusetts representatives to strike meals
from the list of gifts that would be banned under proposed bill S.B. 2660.
We know that pharma has long found ways to get what it wants by talking
through others – physicians, say, or advisors for the FDA. But a tip to the
letter-writers of the world: if you don’t want to look like you were put up to
something, don’t parrot information you probably couldn’t get doing your
job.
The petitioner from RestaurantstoYou moves quickly from entreating to
indignant: “How could we think “the most educated people in the world, Doctors,
could be manipulated by the offer of a ham sandwich and chips from a
pharmaceutical or medical device company sales agent? Instead, the
opposite is true. Doctors routinely ask these reps to go do more research for
them, at no cost to the doctor, so that they can have additional information
for their individual analysis that they will use to make decisions regarding
their patients.”
Abt knows this because he says to better understand his clients, he has
watched from the back of the room in admiration as the reps performed their
lunch and learns. Fine.
But if you are the one making the sandwiches, do you really want to sound
like you are reading off the same talking points as the state policy director
for the PhRMA trade association? PostScript has been to enough hearings to know
those talking points when we hear them. Sales reps with no background in
science are providing valuable information about drugs that physicians can’t
get anywhere else? And pasta salad.
Yep.
No doubt: $40 M is a lot of money to spend on food every year – but if that
number tells Massachusetts lawmakers anything, it’s the sheer scale of
investment these companies have made in wooing physicians, evidence that it’s
probably time for the marketing machine is to be reined in.
If nothing else, it’s intriguing to see pharma moving the mouths of both Ivy
League physicians who are recruited to speakers bureaus where they use
marketers’ slides to pitch their drugs for them, and those of the blue collar
catering drivers from Stoughton: “The food we deliver is wholesome and
delicious, but it is not flashy or expensive.” We have to hand it to
them: The chemical pushers have become deft chameleon puppeteers.
But in another sense, pharma has found authentic common ground with the
simple ham sandwich makers of the world – they’ve got mouths to feed, starting
with the shareholders.
May 22nd, 2008
Reading the fine print
Glad we read the Boston Globe this week, where we stumbled across this great opinion piece by internal medicine resident Dr.
Michael Hochman, who says that recent revelations about pharmaceutical
companies ability to bury unfavorable studies (or just write better ones
themselves) have got him and his colleagues at the Cambridge Health Alliance
thinking twice about the sizeable chunk of industry-funded research in the
medical literature.
“One of the more experienced doctors I work with, for example, told me that he
no longer views industry-funded research as an unbiased source of information
but rather treats these studies like advertisements for pharmaceutical
products,” Hochman writes.
Though he says he’s encouraged by recent changes to limit marketing
influence on good medicine, such as the Journal of the American Medical
Association’s pledge to exorcise itself of ghostwriters, and Boston University
School of Medicine’s recent introduction of strong policies that ban industry
gifts and payments, he will “rely less heavily on studies funded by
pharmaceutical companies when making decisions about my patients. And when I do
read industry-funded studies, I will use the skeptical mindset I developed
during my medical training not only to evaluate the study methods but also to
consider the motives of the researchers involved.”
After the Wire, Under the Arch: med school policies in perspective
The Baltimore Sun ran this comprehensive article on
the AAMC recommendations and the state of pharmaceutical conflict-of-interest
work at the state, federal, and academic medical center level. According
to the Sun, “The Johns Hopkins University and the University of Maryland allow
doctors and researchers to accept gifts that have “educational value” and to
earn money for company-sponsored speeches. Officials at both schools say the
policies are under discussion and might be tightened in response to the new
AAMC guidelines.”
Here’s another good omnibus article in the St. Louis Post-Dispatch on the state of industry
influence on academic medicine – and the effect of the AMSA Pharmfree
Scorecard last year.
According to the Post-Dispatch, after the scorecard came out
“Washington University adopted a policy to ban representatives from interacting
with students without faculty supervision. Among other rules, representatives
are barred from bringing food on campus.”
A second year medical school put it this way: “By the time I’m done, I’ll
have paid a couple hundred thousand dollars for my medical education,” she told
the Post-Dispatch. “I think I’ll be well-qualified enough to
educate myself.”
And the accompanying editorial says that it’s no
coincidence that “Americans spent $216 billion on prescription drugs in 2006,
an increase of nearly 80 percent over the $121 billion spent in 2000.
“The simple truth is that when drug and medical device makers offer a free
lunch, the rest of us pay the bill.”
American College of Physicians mag looks at COI policies
Here’s a great look at what AMCs are doing about industry
influence from a professional perspective. The ACP Hospitalist talks with RxP and a whole starting
line-up worth of adminstrators who have taken their organizations pharm free,
including BUSM’s Dr. David Coleman, University of Pittsburgh Medical Center
associate dean Dr. Barbara Barnes, and SMDC Health System’s Dr. Kenneth Irons,
who took the out-of-sight-out-of-mind approach offshore, orchestrating the
shipment of all his clinics’ pharma gizmos to Cameroon earlier this year.
In Heinz sight
And for anyone who doubts that pharmaceuticals have gotten away from the
science in favor of lifestyle marketing campaigns run by brand-savvy MBAs, we
bring you this nugget, courtesy of the WSJ Health Blog.
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