A Whole New Level of Junk Science

It’s no secret that the pharmaceutical industry trades in junk science. We’ve talked about how prescription drug companies distort research many times here on Health Beat, focusing on how companies fudge measures of drug effectiveness and generally control our knowledge of what works in medication. Big Pharma’s track record of shady science is a serious problem, especially considering the fact that recent discussions about creating a Comparative-Effectiveness Research Institute currently hold a place for prescription drug companies on the organization’s board.

The obvious problem is that, to the pharmaceutical industry, “research” is just a code-word for “smart-sounding marketing.” If you really want a sense of how deep this deception runs, consider the fact that the prescription drug industry relies on so-called “research” not just to shill its drugs, but also to argue that it has a vital role to play in shaping the doctor-patient relationship for the better.

This dubious claim comes in the June 2008 issue of PharmaVoice where Meaghan Onofrey from CommonHealth, a pharma marketing consulting firm, pens a piece arguing that coaching from the prescription drug industry can make sure that “physicians and patients speak the same language” so that “everyone wins.” According to Onofrey, “one case study illustrates [how marketers can help physicians improve their communication]: by videotaping primary-care physicians, who were struggling to assess migraine prevention candidacy with their migraine patients.” According to Onofrey, it turned out that the doctors were actually asking the wrong questions of their patients. In working with key opinion leaders and advocacy groups, a simple solution was formulated to address the issue. These same physicians were taught to ask a single question to help them more simply and clearly identify the patients’ candidacy for migraine prevention.”

You might be wondering what this oh-so-effective single question is—and so am I. Even GlaxoSmithKline’s online “headache quiz,” which users can take to see if they might
have migraines (and thus might be a good target for prescription drugs)
asks eight separate questions of patients. When it comes to migraines,
it’s tough to imagine a silver bullet question.

Yet Onofrey provides no specifics about the “study,” leaving the reader
with a load of unanswered questions. Under what conditions was the
study executed? What were the patient profiles? What was the
patient-physician dialogue specifically like before and after the
“single question” solution? All we get is some PR spin concluding that
it’s important to better identify “prevention candidates” (a.k.a.
potential customers) through “leveraging…dialogues.”

CommonHealth’s research is paradigmatic of pharmaceutical industry
science: talk a big game, but ensure that there’s enough ambiguity so
that the really meaningful results are hidden. This is exactly what we
get in direct-to-consumer (DTC) advertising. Ads for Pfizer’s Lipitor,
for example, claim that the drug reduces the risk of heart attacks by
36 percent because studies show that two patients our of every hundred
on the drug get heart attacks, versus three out of every hundred on
placebos (which is a difference of one patient, or about one-third of
the heart attacks that would have happened without Lipitor). This data
obscure the fact that the drug only helps one out of every one hundred
people who take it.

But there’s something particularly bald-faced about claiming that
marketers can feed doctors a script for the benefit of all involved.
As John Mack, publisher of the Pharma Marketing Newsletter,
points out on his blog, “Although the research is billed as a way that
pharmaceutical companies can help improve physician-patient
communications by helping physicians and patients ‘speak the same
language,’ it obviously may be more useful to CommonHealth’s pharma
clients, who can ‘demonstrate value to physicians beyond just the
benefit of the brand, potentially creating an unexpected, yet mutually
beneficial relationship.’ i.e., sell more drugs.

“So,” Mack asks, “is this research or a sales tactic?”

Meanwhile, the pseudo-science here is just painful: Onofrey claims that CommonHealth’s research is grounded
in “sociolinguistics,” which is…wait for it…the study of how people
speak to each other in different contexts. Sounds flashy, but all it
really means is that the ‘researchers’ tried to get physicians to speak
differently.

This isn’t the first—or likely the last—time that CommonHealth has
twisted poorly-executed research to argue that pharma marketing
practices are benign.  Mack reports that back in 2006, CommonHealth
undertook a study dedicated to proving that DTC advertising isn’t
nearly as bad as critics claim. In the press release for the study,
CommonHealth gleefully announced that its results “challenge many of the assumptions of both academic and public policy critics of DTC.”

First, here’s CommonHealth’s description of the study, which it called
an “an exhaustive analysis of 440 transcripts of actual
provider-patient interactions in community-practice settings. The
transcripts were all recorded between 2001 and 2005, and examined the
nature of patient medication requests, references to DTC in the
dialogue, and the overall nature of the risk-benefit discussion in
three therapeutic categories.” Based on these transcripts,
CommonHealth’s team concluded that “patient-initiated prescription drug
requests are not driven by DTC advertising.” In fact, the press release
reports that “DTC advertising was referenced by patients in just 0.6
percent of visits, and that “DTC advertising does not harm the balance
of [discussions assessing the risks and benefits of a given
medication], regardless of DTC spending in the given category.”

According to Brad Davidson, the project’s lead researcher, these
findings supposedly confirm that “DTC does not have the negative impact
on the actual dialogue that many people allege.” John Kamp, executive
director for the Coalition for Healthcare Communication, an association
of medical marketers and advertisers, insists that “these facts will
disappoint some who wish to restrict or ban DTC” and that “others who
wish to improve DTC will be both better informed and challenged as they
seek to better educate patients and improve the doctor-patient
discussions that drive patient compliance with their healthcare
regimens.”

So what’s wrong with this picture? First, Mack pointed out
in 2006 that CommonHealth stone-walled him when he tried to get access
to the study. Ultimately, Mack had to go to the FDA and submit a
Freedom of Information Act request for the information. Once he got his
hands on the study, Mack posted it
on his blog and noted that it’s little more than  “a cover letter and a
slide deck,” far from the “raw data, multiple tables, and…detail about
methodology…that a [supposedly] ‘data-driven’ agency like the FDA
demands in medical research.

The real ‘gotcha’ moment comes in the following slide:

Patientrx

Mack points out the problem: “Here, we can see that there were 585
mentions of a brand name drug either by the doctor or the patient
during the 440 visits recorded. True, the doctor initiated the
discussion in the vast majority of cases (455 or 78 percent of the
mentions). Yet the patient mentioned a brand name drug first in 130
cases or 22 percent of the mentions. That’s a far greater percentage
than” the 0.6 percent that CommonHealth talks about in its press
release.

That’s because CommonHealth is hyper-selective in reporting its
numbers: the 0.6 percent refers only to patients who specifically
referenced advertising and asked for a medication. Joseph Gattuso,
president of CommonHealth’s MBS/Vox (Mind, Body, Spirit, and Voice)
division—which, according to its website,
“specializes in ‘reality-based’ approaches to marketing insight based
on dialogue between physicians and patients…and other healthcare
interactions”—summed up the .6 percent number best, when he said that
“it doesn’t appear that a high percentage of patients are going to the
doctor and directly [emphasis added] saying, ‘I saw X brand on TV and
that’s what I want.’”

Would you tell your doctor you want a medication because you saw an ad
on TV? Or would you say “I’ve heard about brand x –it sounds good.”
Either way, chances are, the only reason the patient knows and
remembers the name of a new brand is because he saw an ad on television
that was designed to plant the name in his memory.

As Mack explains: “Gattuso is not talking about how often discussions
about brands take place in the doctor’s office—he’s talking about
whether or not the patient mentions seeing the brand advertised. In
other words, CommonHealth is focusing only on how often DTC is
mentioned in doctors’ offices, not how often brands are mentioned.”

Meanwhile a write-up about the study in Pharmaceutical Executive Magazine, willfully distorted
the results, claiming that CommonHealth’s study “sought to determine
how often discussions about prescription brands were taking place…” No,
the study showed how often patient and doctor discussed television.

There’s something uniquely unsettling about the fact that the
pharmaceutical industry is ready, willing, and able to claim that its
marketing is actually some perverse form of community service. It’s one
thing to claim that a drug works when it doesn’t, but there’s something
especially weird about insisting that advertising can—and
should—effectively structure patient-physician interactions. This point
is all the more perverse because the same organization that’s saying
marketers should mold discussions is also claiming that DTC advertising
doesn’t do so. There’s a disturbing undercurrent of social conditioning
here that is played up or played down depending on what is most
convenient for prescription drug companies.

This is all very audacious, even for Big Pharma. The lengths to which
these marketers are willing to go to prove that their product is
beneficial and desirable are stunning, and this drives home a point
that health care reformers need to keep in mind: These are not the
people we want involved in medical research. They have a deep interest
in choosing spin over science and pursuing “research” in the service of
marketing. These are not the priorities of a high quality health care
system. The CommonHealth PR logic needs to be kept as far away from the
proposed Comparative Effectiveness Institute—and health care in
general—as possible.

12 thoughts on “A Whole New Level of Junk Science

  1. Gee, if you think you’ve got a case for civil fraud —
    Why don’t you hire John Edwards, Esq., on contingency and sue for damages? And become a millionaire?
    ¡Si, se puede!

  2. Well said! I recall when the drug companies were allowed DTC ads on TV, and thinking, “this will be a disaster for good patient care.” We’re inundated with ads, yet consistently reports come in that new brand name drugs do no better than older generics for treating the same problem.
    Also, Big Pharma makes the incorrect assertion that all medical problems require medication to control or prevent. Diet, exercise, and stress control are just as important, if not more so.
    The conflict of interest in having them on an advisory board is too great to be ignored. Yes, they should be able to present their point of view before such a board. But to have a vote on public health policy is like having a fox guard a henhouse.

  3. At some point you would think [hope] that the members of this highly [over] venerated “profession” would actually understand what is going on here. Now I know they are not much for “statistics” as most of them come from the social sciences rather than “hard” sciences, but do they not realize that Big Pharma is bleeding every last ounce of intangible value [public trust] out of the physician-patient relationship?
    Once it is gone . . . once doctors are viewed in the same way as mechanics (“I have the newest brake pads . . . er . . . medicines for ya!”) then it’s gone and it’ll take a long time for them to earn it back.
    At the end of the day, they – of all professions – are offered much more leeway in the form of self-regulation and self-licensure. Maybe they could use a little more public [government] scrutiny and oversight. Eventually it will come to that if doctors keep acting like greedy pez dispensers sucking in “consulting fees” and spitting out pills.

  4. Morris Berg wrote:
    “At the end of the day, they – of all professions – are offered much more leeway in the form of self-regulation and self-licensure.”
    ———-
    Interesting questions arise in my mind concerning professional trust and what happens when it is lost! If a profession loses public trust, does it ever get it back, and is it still a profession anymore?? Also if that profession provides a social necessary function, what takes its place (if anything) once it loses public trust? Curious minds want to know.
    BTW, I totally agree with most of Morris’s post!

  5. I agree that trust in, what I commonly call, this “miracle idustry gone completely sour” may take decades (if ever!) to regain.
    And YES the doctors are complicit in many cases.
    But I want some CEOs in Big PhRMA to get jail time. Fines and legal settlements ARE NOT ENOUGH!
    Some of this behavior meets the criteria for criminality.Human lives are at stake!
    Dr. Rick Lippin
    Southampton,PA
    ralippin@aol.com

  6. I see it all the time and I have to laugh and sometimes make fun of that pseudo data that is being presented by drug reps. Then I tell them that they get into a more legitimate business while they still have the chance. The drug detail people are chosen for their appearance and sales techniques and not for their ability in science.
    The trouble is that physicians frequently accept the detail person’s presentation as medical education. More second, third line drug and totally ineffective drugs are presented as the doctor’s answer for sick patients.
    An even more malicious form of this kind of abuse is in television advertising directly to the patients. We’ve all seen this pandering to the public where a video is shown of the active patient having the time of their life while a low pitched voice is saying, “can cause permanent liver damage, suppression of the bone marrow or death in rare cases.”
    A particularly striking example for me in my own family was taking Celebrex for moderate arthritis. Her response was good, but she was paying an exorbitant price and exposing herself to greater risk for adverse reaction which again can contribute to more medical care.
    Many of the generic Medicaids that work equally as well have many patient-years of acceptable risk. While “long term” studies of tolerance to a new drug only last for a few weeks. These studies do not have the time or the patient numbers to reveal potentially fatal reaction should there be a potential for death or serious disease. It frequently takes years to identify such adverse reactions and by that time the drug is off patent.
    Unfortunately the patient population seems to favor “newer” medication for chronic disease with the assumption that it will be better. With this misconception there is some expectation for a cure that isn’t going to happen. When you question the patient the reason they desire change is related to a hope for a cure when none is available. In actuality, the patient just got tired of taking their old medication and stopped. They then make the assumption that it didn’t work.
    This whole phenomenon of patient demand presents a bind for the physician who wants to please the patient and not appear behind the times. Rather than explaining the rational for continuing the first drug, doctors choose to write out a new script and clear his waiting room faster. This cost shifting abounds in medicine related to special surgeries, needless procedures, and treatment and many other forms.
    When a system is stressed beyond its normal limits trade offs for one primary physician and produce many multiples of the original costs.

  7. Something of a followup for Greg’s example of Celebrex. I know several pain management specialists that feel they want to have the OPTION of a COX-2 inhibitor available, Celebrex being the only one still marketed.
    Now — for them to prescribe it, they would have exhausted nonspecific NSAID COX inhibitors (or at least three classes), and, at least a trial of what is apparently one of the most underprescribed agents, tramadol. By exhaustion of NSAIDs, I do include the case where the problem was GI distress, and concomitant use of misoprostol was unwise.
    That’s the main point when they wanted the option of a COX-2 inhibitor: when the next choices on the WHO pain ladder were codeine, hydrocodone, or methadone. A couple commented that they MIGHT want to try a COX-2 inhibitor at that point, on the chance it had anti-inflammatory action.
    These are people that know what they are doing, and know how to stay out of trouble, with appropriate long-term opioid therapy. They really felt Celebrex was a niche drug, but there were times it was useful.
    What’s the right policy in a case like this? That restrictive a use probably would make it uneconomic to the manufacturer. Pull it completely? Or, perhaps is done with some drugs for tropical diseases, or when manufacturing of streptomycin or sulfadiazine stopped, have CDC contract for a supply? I’m not sure the latter makes sense for an analgesic.

  8. Usually it’s the doctor who introduces ‘the-latest-greatest-miracle’ medication to me. I don’t trust most drugs introduced within the last 5 years and prefer something with a track record. When I tell doctors that, I’m given the most confused looks. I’ve gotten comfortable with a couple of them to ask where they get drug information and walk away with the concept that most doctor’s are too busy to do indepth research on which studies are valid, who’s paying, financial interests, and all the details. If it’s recommended for a specific reason, they will try it if for no other reason than it’s what they are more likely to remember.
    Just not on me.

  9. Why don’t people take their medications? Because they cost too much! I’ve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. I’ll bet they are charging more than $18 for this new drug! Don’t pressure your doctor into giving you something just because it’s new. Do your homework. Find a drug card like I did at http://www.rxdrugcard.com. I think that RxDrugCard.com is the best drug card available for prescription discounts.

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  11. I’ve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. I’ll bet they are charging more than $18 for this new drug! The unthinking public is going to pressure their doctors into giving them something just because it’s new when something old or generic would do the job for cheaper.

  12. My name is Laura Arena and i would like to show you my personal experience with Lipitor.
    I am 58 years old. Have been on Lipitor for 6 months now. It did lower my total cholesterol from 235 to 200.
    I have experienced some of these side effects-
    After three months on Lipitor, I started to feel like an airhead — slightly dizzy virtually all the time and frequently unable to think clearly. I actually started to wonder if I were developing early Alzheimer’s (I’m 58). After five months, I developed severe pain in my thighs and knees and I’m exhausted all the time.
    I hope this information will be useful to others,
    Laura Arena