New Cholesterol Controversies: Regaining Perspective

Cholesterol drugs are making some of the big news this week. First, we read that Pfizer is facing a whistle-blower lawsuit regarding purported off-label marketing of Lipitor--trying to persuade physicians to prescribe the drug for lower-risk categories of patients than officially approved (for a wrap up see the WSJ Health blog, http://blogs.wsj.com/health/2007/12/20/a-jug-of-wine-a-loaf-of-bread-and-lipitor/). Then comes the news that Merck and Schering-Plough, already under fire for the delays in releasing the ENHANCE study of Zetia, have been hit by reports that they also have failed to publish other research showing liver damage in patients taking that drug. The risk is admittedly low, but apparently more than had earlier been admitted (see Berenson in today's New York Times).

It can be a bit challenging to keep all this stuff in perspective--what does it really mean for the treatment of high cholesterol? Here's my view.

Recall that Lipitor, along with Zocor and numerous other drugs, are all "statin" drugs, that reduce cholesterol levels by a mechanism that involves the liver. Zetia is a drug in a different family, that reduces cholesterol by other means. Vytorin is a combination pill that includes Zetia plus Zocor.

Who now is prescribed Zetia? As a rule, two major groups. First, people with high cholesterol but who cannot tolerate taking a statin for any of several reasons. Second, people taking a statin in maximum doses, whose cholesterol levels still remain about the guideline "target"
level, may then have Zetia added to the statin in hopes that two drugs will prove better than one in lowering the cholesterol, as indeed they usually are.

So one naturally wonders, as well as what the risks are for these people taking Zetia, just what benefits they might expect.

For Zetia alone, the answer is pretty clear. There is no evidence whatever, in the long term, that taking Zetia reduces your risks of having a heart attack, stroke, or other bad result from cholesterol messing up your arteries. ENHANCE was supposed to provide a glimmer of such evidence by at least saying what effect Zetia had on plaque inside the arteries, but even that has been held back, leading us to fear that the actual trial results were probably unimpressive. And even plaque thickness is a "surrogate endpoint," not a real outcome of interest such as stroke or heart attack.

So, if Zetia alone has no proof of benefit, what about adding Zetia to a statin? That in turn leads to the question--what evidence is there for giving a statin, and adjusting the doses, based on lab measurements of the patient's cholesterol level?

The majority of patients taking a statin for prevention of bad stuff have no known vessel disease, just a risk for developing it later. (This is called "primary prevention.") There are two physicians who have spent a good deal of effort looking at the statin-primary prevention story. They are James Wright of the Therapeutics Initiative project at the University of British Columbia, a well-staffed and well-respected group capable of doing independent analyses of drug trial data; and John Abramson, author of Overdosed America, who gave up medical practice for several years so that he'd have time to do his own number-crunching on the same data. They published their conclusions recently in Lancet, but earlier work on the statin question can be found at the Therapeutics Initiative newsletter:

http://www.ti.ubc.ca/en/TherapeuticsLetters

I believe that their data are persuasive, especially compared to "official" guidelines written by physicians of whom a majority have financial ties to the pharmaceutical industry, as I describe in HOOKED.

Wright and Abramson point out that there is very weak evidence for statins being good for primary prevention. The data are especially weak for two groups--women, and men over aged 65. Since statins overall are very weak for primary prevention if they work at all, there is little reason to get worried about how much they should lower your cholesterol, or what the ideal target level is that your cholesterol should drop to, or any of the other questions that physicians spend a lot of time obsessing about these days if they follow the official guidelines.

Secondary prevention--taking a statin if you already have known vessel disease, such as a previous heart attack--is quite different. The evidence seems very clearcut that statins really help prevent later heart attacks and strokes in that setting. I would go so far as to say that if I had a heart attack, the very first sip of water I took afterwards, I should be swallowing a statin tablet with, and keep on taking one daily as long as I lived.

So you would think, then, that since statins work for secondary prevention, it would make sense in that group to ask what the target cholesterol should be, or what the ideal dose of a statin is, right? Well, Wright's gang looked at those studies and could not find enough evidence to recommend any given target level to achieve, or any specific dose of statin to achieve it with.

The bottom line seems to me to be:

1. Zetia is unproven for anything of real importance.
2. Statins are of very litttle use for primary prevention. If they benefit anyone, they benefit men below age 65 who also have several other risk factors for cardiovascular disease.
3. Statins are excellent for secondary prevention, but we cannot say what dose you should take, let alone what target cholesterol level to aim for, to maximize that benefit--all we can really say is, take a statin.
4. All this business of checking your cholesterol level, and then adjusting the dose of the statin (or adding a drug like Zetia) if you are not reaching the target, is voodoo. It has basically been made up by well-intentioned "experts" but it is not based on firm evidence.

So if all that is true then we can draw the following conclusions about this recent news:

• There are far too many people already, so far as we know, taking statins; so any marketing that tells us that even more people need to be taking statins is probably a bad thing. (On the other hand, if any people with previous heart attacks, strokes, etc. are not taking statins, they should start.)
• Since there is no known benefit to taking Zetia, any added risk from taking it can hardly be justified.

A couple of footnotes. First, I have said nothing here about how statins compare for either primary or secondary prevention, to lifestyle changes such as diet and especially exercise. Dr. Abramson has some choice words on that subject in his book, and they are not friendly to statins. Second, Alex Berenson in his great NYT article today mentions in passing that when the FDA approved Zetia, they relied on studies looking for possible side effects that lasted, at a maximum, 12 weeks. That is for a drug that is designed to be taken for a lifetime, and where other cholesterol-lowering drugs are known to have side effects that may not show up for months or even years after the drug is started. That fact alone is unconscionable; and shows again how the FDA, at least until very recently, was the industry's lapdog. (And even the 12-week-long studies revealed some concerns about liver damage in people taking Zetia, which was then glossed over!)

Berenson A. Data about Zetia risks was not fully revealed. New York Times, Dec. 21, 2007.
Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet 2007; 369:168-9.

License Drug Reps? Sorry, Dumb Idea

The Washington Post reports on this week's DC City Council vote (7-6) to require licensure for pharmaceutical reps:

http://www.washingtonpost.com/wp-dyn/content/article/2007/12/11/AR2007121102284.html

Now there are several reasons that I should be in favor of this:

• It seems to be giving PhRMA the fits.
• The sponsor of the legislation, council member David Catania, seems to be a very nice fellow who is getting a solid reputation for his involvement in the pharmaceutical marketing issue nationally.
• It seems to be giving PhRMA the fits.

Sadly, I am obligated on this blog to try to be responsible and not give in to my baser nature, and so I must report that I cannot see any practical justification for this proposal.

The drug rep problem in medicine could be solved overnight. Tomorrow, all physicians could wake up and discover that they possess an interesting ethical organ, known as a spine. (They could also, if they are of the male persuasion, discover that they have a couple of other organs that might be relevant, which I will not go into here.) Utilizing this new-found piece of anatomy, we could decide that from now on we will get our information on drugs only from reliable, non-commercial sources, and that we will make do without the corrupting influence of the cornucopia of gifts from the industry. The industry would immediately lay off all the reps, since if no doctor is willing to see them they are useless.

Problem solved, and no licensure apparatus needed.

Obviously this will not happen overnight, so the licensure thing would be worth thinking about if 1) it might move us incrementally closer to that Promised Land; or 2) it would be of sufficient symbolic value that it would energize and enlighten the masses for the remainder of the work to be done. I admit that I am not sufficiently imaginative to see either of either of those other consequences coming to be. Licensing reps just doesn't have that energizing zing that a really useful symbolic act can have. And it seems unlikely to do anything of substance to make the drug rep problem any more manageable in the short run.

Now, I have been wrong before. I initially was wary of the legislative proposals to outlaw data-mining of prescription information, which has been a big issue among my esteemed colleagues in the National Physician's Alliance (http://npalliance.org/). I now see that those policy measures have in fact been more useful than I imagined they would be, even if only for rallying physicians. So maybe somebody can talk me into switching sides on the DC City Council. But I remain to be convinced. And just because something gets PhRMA's knickers in a knot is not a sufficient reason to favor it, as tempting a criterion as that is.

Much Ado in Springfield, IL

OK, guys, it is a long story, for a town that used to seem like nothing much happened there since they buried Abraham Lincoln in 1865.

The first thing that happened is a drug rep dinner gone sour, which has ended up in threats from some local docs of a libel action against a drug rep whom they accuse of sending out poison pen letters about them. The brouhaha attracted the notice of a local health reporter, Dean Olsen, to whom I'm grateful for most of this information. The newspaper, the State Journal-Register, quite correctly noted that while the flap between the drug rep and the docs was the apparent headline, the real story had to do with the ubiquity of these dinners and the way that the industry woos physicians, and addressed these larger issues in a nice editorial:

http://www.sj-r.com/Opinion/stories/21714.asp

The editorial itself is interesting, but especially interesting is the strong of comments e-mailed in response. (I'm writing this as there are 34 comments posted; by the time you log on there may be more.) Seems like this issue really struck a nerve. On the one hand is an avid free marketer who is upset at any suggestion that drug reps should be restricted or regulated, and is quite blunt about what this is all about (selling, not "education"):

So now the SJR is against sales people? I dont see a problem with the drug reps hosting dinners for the Doctors. If you have ever been to a doctor's office, you will notice that they are very busy. The only time a drug rep has a chance to meet with the doctor in order to sell his drug is usually at on off site event.

Some folks responded as you'd imagine they would, and so this commentator came back with:

So, you guys are saying that it is wrong to take someone to lunch or dinner? Jeez, get with it, that is the way business works. Maybe not in your liberal textbooks taught by bearded professors who enjoy tenure and never have to work for a living but it is reality. Business entertainment is not limited to health care. They all do it. Why? Because it works. I took a client golfing in North Carolina. Why? I got to spend 8 hours with the guy discussing the benefits of my product. And why do you say that the sales people lie? Honestly, I think the customer lies much more often than sales people. Bottom line is in order to sell your product you have to tell people about it. This dinner was a way for the drug rep to bring his expert in and speak with the doctors.

(Note to anyone interested: I do not have a beard.)

Another commentator came to the reps' defense as the bearers of samples:

So the SJR wants freebies stopped. OK - then the paper can explain to patients who cannot afford their medication why free samples are no longer available. For some, the free samples left by drug reps are the only access they have to necessary medications. How many times have you gone to the doctor and left with samples of your medications? Did you enjoy not having to pay for them? Thank a drug rep (and his/her company!). Granted, drug companies are not all wonderful, but they and their reps are not truly evil either. Everyone needs to get their facts straight about how drug reps REALLY do their jobs before slinging insulting and erroneous opinions. It is hard work that often does NOT result in the doctor writing your drug. BTW, no, I am not a rep, just someone who actually cared to be informed before judging others.

Someone else added approvingly:

Thank goodness for the free samples the drug rep give out. Without them and their free samples, we would have a national health care crisis.

Whew! And here I thought we already had a national health crisis. Silly me.

This could go on forever but I will close with a comment from someone who sees it from the restaurant side:

Several years ago I worked for a restaurant that was attempting to build up it's lunch delivery business. Quite by accident I discovered the "drug rep" market and immediately capitalized on it since I was on commission. I also discovered that there were many local doctors who would only see a drug rep if they provided lunch for the entire office staff - no exceptions. The doctors considered it a perk that they were providing free daily lunch for their staff even though it didn't actually come out of their (well-compensated) pockets. Guess who really pays for all these free lunches. You and me, every time we buy medicine. Very few people know about this corrupted system unless they work in this industry. I believe this should be regulated the same way we've restricted the way our elected representatives can be lobbied (which isn't perfect either, but better).

AMSA's Pharm-Free Campaign; Student Activism at UNC

Anthony Fleg, a medical student at UNC-Chapel Hill, is also the leader of the American Medical Student Assn's Pharm-Free Campaign. He kindly alerted me to several developments, including the updated website for their Campaign:

www.pharmfree.org

Anthony and his fellow students have been agitating at their own school to try to limit drug company marketing influence-- see some excellent publicity they gleaned:
http://wunc.org/tsot/archive/sot1205a07.mp3/view
http://triangle.bizjournals.com/triangle/stories/2007/12/03/story2.html?b=1196658000^1557919

The Public Radio story (first link) has a great interview with ethicist Dr. Philip Rosoff at Duke, who pulled no punches in describing the ethical problems raised by Pharma's influence over academic medicine. The newspaper account (second link) is interesting in featuring an interview with Dr. John Buse, one of the medical faculty at UNC. I recently had occasion to reflect on Dr. Buse's case on this blog:

http://brodyhooked.blogspot.com/2007/11/intimidation-of-dr-john-buse-some.html

Not too surprising, Dr. Buse was concerned in his interview about losing the funding the drug companies provide if UNC gets too picky about its ethics.

The Public Radio interview also gave some play to the "report card" that AMSA did of all US medical schools. (They gave their own school, UNC, a "C minus.") Since I have your attention, I will add that we squawked loudly when they gave us an "F" here at University of Texas Medical Branch in Galveston; we thought we deserved at least a C-minus by their official criteria--not that that is much to be proud of. All that goes to say is that the "report card" has turned out to be a very useful publicity device--kudos to the students for thinking of it. AMSA can continue to put the rest of organized medicine to shame for the excellent job they are doing on this issue.

On the Pediatric Treatment of Post-menopausal Women

Some time back, Congress decided to do something to support pediatric research. A recurring problem is that drug companies do not do clinical trials of drugs in children, and so pediatricians have to more or elss guess what doses to use based on adult trials. This occurs because the sales in the pediatric age group might not be great enough to provide an incentive for extending the drug's FDA-approved label to kids. Thinking that the industry needed a carrot, Congress passed a law that allowed a 6-month patent extension on the drug for doing appropriate pediatric research.

Critics of the industry, like Marcia Angell (The Truth about the Drug Companies) charge that Congress miscalculated, and that the value of the 6 months of extra patent protection is now so high that companies are testing drugs that will never realistically be used in kids, just to get the extra patent life.

A recent example of this seems to be the following news release:

http://www.astrazeneca.com/pressrelease/5362.aspx

Arimidex is currently approved by the FDA for use among post-menopausal women in treating breast cancer. AstraZeneca was very happy to announce that it has received an extra 6 months of patent protection due to their conducting pediatric research. Apparently the company decided that maybe conditions in kids that result from excess estrogen, such as breast enlargement in pubertal boys, might be helped by the drug. After doing the research, said the company, they concluded that they would not seek any FDA approval to use the drug in children, after all. (Surprise.)

Out with the Reps, In with the Internet

A while ago, us critics of the medicine-Pharma interactions thought that we might prevail if we could only convince physicians that their cozy interactions with drug reps were not as "back room" as they thought but actually were occurring in a fishbowl--that patients and medical students, for instance, were seeing all this happen and not liking what they saw.

Maybe it worked.

The AP reports that the industry is now intent on scaling back its face-to-face rep action in favor of selling over the Internet:

http://ap.google.com/article/ALeqM5jsqQWRot1GZFb2B489NfPcSwboBAD8TARALG0

There are a number of factors at work--the drug rep arms race that admittedly, to most industry insiders, flooded the market with too many reps; the rising costs of marketing coupled with fears of lower profits as blockbusters go off-patent; and the times, with many of us staying away from the mall so that we can shop on Amazon and eBay.

The article from AP states that docs in many cases refuse to see reps at the office, but are willing to spend 10 minutes talking with a rep by phone as the rep directs the doc to an Internet site with glitzy video presentations about new drugs. The article is silent on the gift angle. Most home computers, last I heard, are not set up to dispense gourmet dinners, or even pens and mugs; so the doc cannot get rewarded as per the old-fashioned rep visit. I believe that e-mail or mail vouchers for various benes have been used in connection with Internet marketing, but this particular story provides no details, and I'd like to hear more from others in the know.

Is this a good or bad development? If, by chance, the gift element has been removed (which I doubt), then maybe things are better. But we still have docs using commercially biased sources of information instead of doing some independent thinking and searching for more reliable data, which cannot be good for patients.

Off-Label: What Are the Issues?

The Prescription Project blog has several links to recent news coverage of the FDA's proposed rules change that would allow companies to market off-label uses of drugs in very limited ways (Dec. 7 posting):

http://prescriptionproject.org/blog/

What I want to do here is to lay out some concerns about the entire "off-label" issue. My worries are that we have been a bit lazy in attacking Pharma's sleazy marketing behavior. Given our natural outrage over the real violations of scientific truth and integrity, we can easily fall into the trap of deciding that anything that places any limits at all on Pharma marketing is a good thing, independent of the actual merits of the proposal. I am afraid that the "off-label" debate has done us the disservice of creating a dichotomy that is not valid--that "on-label"/"off-label" somehow corresponds to good/bad or rational/irrational uses of drugs.

True confession time--in 26 years as a family physician, I probably prescribed a lot of drugs off label. Even truer confession--when I prescribed drugs off label, a good deal of the time, I had no idea that was what I was doing. How could this be?

The basic fact is--how does a practitioner know what is on-label? You have to read the label. How do you do that? The easiest way is to look up the drug in an industry source such as the infamous PDR. There, the label hits you square in the face. Indeed, everything in the PDR is the label and only the label. For that reason we try to teach our med students and residents not to use the PDR as their primary reference source on drugs.

So instead of using the PDR, I look up the treatment for a given disease in a reference that appears to me to be reasonably evidence-based and non-commercial. Now, in so doing, that source might mention which uses of the drug are listed on the label. But my main concern is not that, it is what drug is good for that disease. So I could easily miss noticing the details about the labelling.

All of the above might simply mean that I was a rotten doc. But the following considerations clearly show that "off-label" is hardly synonymous with bad or suspicious prescribing:

1. The great majority of pediatric prescribing is off-label as many very useful drugs have never gotten formal FDA approval for use in kids.
2. When an old generic drug is found to be useful for a new disease--such as hydralazine and isosorbide in combo for heart failure, especially in African-Americans--its use will certainly be off-label, as the generic manufacturers will never pay to do the new clinical trials needed to expand the FDA labeling.
3. Like everything else in Pharma, the decision as to what studies to fund or not by the industry is a marketing decision, not a science decision. The fact that a given indication for the drug was not researched, or that supporting studies were not submitted to the FDA, may have precious little to do with whether that drug is any good or not.
4. And, finally, we all know examples where the FDA labeling process has simply not kept up with what reasonable medical judgment is aware of. The makers of Neurontin were quite legitimately taken to the woodshed for their off-label marketing of the drug for numerous psychiatric disorders, for which it is probably no good. At the same time, the use of Neurontin as adjunctive treatment of chronic neuropathic pain was probably a reasonable choice, even though equally off-label.

Is it a good or bad idea to allow drug companies to market off-label uses? Knowing how the industry can drive a Mack truck through any tiny opening we allow, maybe the best choice is to keep the strictest limits in place. But I cringe when people get sloppy about "off-label" and suggest that the term has some real, medical (as opposed to regulatory and bureaucratic) significance.

More on the True Role of Drug Reps

This post provides no surprises for anyone familiar with these matters, but the quote that follows is so direct and succinct that I could not refrain from putting it out.

Shahram Ahari, former drug rep and now faculty member in Pharmacy at UCSF, has become deservedly prominent among critics of Pharma for publications such as:

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040150

Recently (Nov. 8) Mr. Ahari spoke to Capitol Hill staffers regarding the Sunshine Law that would require disclosure of all Pharma payments to physicians nation-wide. He kindly shared his testimony with the National Physicians Alliance. He said, in part,

Part of our job as reps is to cultivate the illusion that doctors can’t be swayed by measly drug reps. And we help the doctors rationalize this by being one of the few friendly faces to enter their office not complaining about their symptoms or paperwork. Doctor, how can you who has 4 years of graduate education plus many years of training be swayed by little old me?

We all know that when physicians protest that they are immune to the marketing wiles of the industry, it's rationalization and not reality. This quote simply drives home what we have long realized, that the rationalization process is very much in the interests of the industry, and they are prime enablers in our own unprofessional behavior. (We docs must still own our own lack of professionalism and our willingness to lap up these convenient rationalizations from suspect sources.)

Drug Industry: Business Is Bad, Part II

My earlier post on this topic--

http://brodyhooked.blogspot.com/2007/11/drug-industry-business-is-bad.html

--was based on an article in The Economist. This time it's the Wall Street Journal that has discovered mostly the same set of facts.

Key quotes:

"Over the next few years, the pharmaceutical business will hit a wall... Generic competition is expected to wipe $67 billion from top companies' annual U.S. sales between 2007 and 2012... that is roughly half of the companies' combined 2007 U.S. sales... 'I think the industry is doomed if we don't change,' says Sidney Taurel, chairman of Eli Lilly... 'The era that created the modern pharmaceutical industry is in fact over,' said Richard Evans,...pharmaceutical consultant... Pfizer is slashing 20% of its sales force, AstraZeneca is cutting 10% of its employees and Johnson & Johnson is shrinking its staff by 4%..."

Some points that seem new to this article: it is suggested that the industry's huge investment in centralized, expensive research based on discovering new molecules and then figuring out what they might be good for, is in part to blame for the dry research pipeline. It may be the case that you simply cannot do science on an assembly line. You need to understand basic biological mechanisms before you can find the next generation of new drugs. Hence, as noted previously, the industry's current love affair with biotech, both buying up biotech firms and creating in-house biotech units.

If you can't lick 'em-- as it seems that the generic manufacturers are getting ready to profit handsomely as popular drugs go off-patent in the next several years, the big companies are ramping up their own generic units to get a bigger piece of the action.

"The dearth of new products has led the industry to invest heavily in marketing and legal tactics that squeeze as much revenue as possible out of existing products." Well, duh-- hence this blog. If the companies were making windfall profits by discovering and selling new drugs that made us all healthier and that cured deadly diseases, there would be no complaints.

Martinez B, Goldstein J. Big Pharma faces grim prognosis--industry fails to find new drugs to replace wonders like Lipitor. Wall Street Journal, December 6, 2007, A1.

"Intellectual Bias": Latest Salvo from Pharma against Reformers?

Okay, I will admit this--I have officially become paranoid. Where others see only individual actions, I now see an orchestrated conspiracy. In a way my paranoia is self-congratulatory. Because those of us who are advocating serious reforms in the medicine-Pharma relationship are finally starting to be heard, we now threaten the industry sufficiently to make us worth powder and shot for a counter-attack.

The first form of counter-attack I became aware of is efforts by industry apologists, like law professor Richard Epstein at Chicago, to re-define "conflict of interest" so that it no longer worries us as an ethical issue. (I'll address that in another venue.)

The second form of counter-attack, I will suggest, shows up in this month's issue of Critical Care Medicine, in the form of a charge of "intellectual bias."

In an exchange of letters to the editor, three NIH scientists, Peter Eichacker, Charles Natanson, and Robert Danner, attack critical care guidelines promulgated by the Surviving Sepsis Campaign. They detail their disagreements with the position those guidelines took in recommending the very expensive drug, Xigris (recombinant human activated protein C) sold by Eli Lilly. (HOOKED details the earlier chapters in the Xigris saga, when Lilly recruited some of my own colleagues in bioethics to inveigh against "unethical rationing" of care in ICU's when many intensivists read the literature and decided that Xigris was simply not worth its high costs.) They point out the many avenues of commercial influence on the SSC, and how other medical groups in Europe and elsewhere are calling for new studies or otherwise rejecting the SSC's advice.

Two members of SSC, Phillip Dellinger and Charles Durbin, then proceed to reply, mainly in the form of accusing the NIH scientists of having no real evidence to back up their claims and yet repeating their attacks on Xigris incessantly despite having no evidence. Here is the key paragraph:

Drs. Eichacker, Natanson, and Danner accuse the SSC of being biased toward industry, yet fail to acknowledge their own intellectual (academic) bias. This form of bias can be defined as presenting personal, entrenched beliefs as scientific truth in an area where no clear-cut consensus exists. We believe this intellectual bias can be more insidious and damaging than the potential bias arising from affiliations with industry.

Now, this is quite a piece of work. The NIH scientists believe that the preponderance of the scientific evidence supports their point of view. The SSC guys believe the same for their own point of view. That makes the NIH people guilty of "intellectual bias" while the SSC remains innocent of that sin.

What is even more breathtaking is that intellectual bias (whatever that turns out to be) is actually much worse than commercial bias. As I have reviewed in HOOKED and on this blog, and as numerous meta-analyses and systematic reviews have shown, commercially sponsored studies are roughly 4 times more likely than neutral studies to favor the company's drug. So commercial bias has been shown to be real and substantial. Against that empirical proof, we are being invited to dismiss commercial bias as no big deal, but to quake in our boots at the possibility of "intellectual bias."

The implicit subtext, as best as I can read it, is that people ("academic intellectuals") who work at NIH, or at universities that believe in avoiding conflicts of interest with industry, are some sort of ivory-tower, goody-two-shoes weirdos. They think they are intellectually superior to the rest of us mere mortals, and the best thing to do with these insufferable twits is to ignore them. By contrast, scientists who jump into bed with industry at the first opportunity are regular people just like us, and are hard-headed, pragmatic realists. Their take on the world is much more reliable.

Stay tuned. I expect to see charges of "intellectual bias" repeated regularly whenever Pharma feels that it is being placed on the defensive by demands for reform.

Eichacker PQ, Natanson C, Danner RL. Separating practice guidelines from phramaceutical marketing [special letter to the editor, with reply]. Crit Care Med 35:2877-80, 2007.

A Couple of New Blogs/Sites

This is a quick message to alert readers to some sites I just became aware of today. First, anyone lusting for an illustrated inventory of all the goodies that drug reps leave for doctors can find it at:

http://drugreptoys.blogspot.com/

You might want to do your on line Christmas shopping here.

Next, it seems that some HIV physicians have taken off the gloves and gone after their peers who are scarfing up the big bucks from the drug industry. The site is not afraid to name names:

http://www.shillfactor.net/writereport.html

It has long seemed a problem to me that being a paid shill for the industry is apparently a no-consequences move for an academic physician. A few more websites like this one and that could change.

Are Devices Different from Drugs?

John, Swen, a Pfizer VP, asked a very good question at a health policy forum in Minneapolis last month. Minnesota, as I have noted in earlier posts, has one of the most stringent programs in the country for recording and publicizing the money that physicians in the state get from drug companies. So why, said Swen, do the device companies get a pass? Why does the law only apply to drug manufacturers? The Pioneer Press reported on the debate:

http://www.twincities.com/ci_7505789?IADID=Search-www.twincities.com-www.twincities.com&nclick_check=1

Essentially two answers were given in the article, neither satisfactory. First, it was admitted that when the current laws were written, device makers were simply not on anyone's radar screen. Second, many medical device companies are based in Minnesota and have a lot of political clout.

The question, "Are devices just like drugs or not?" keeps popping up and so I am going to restate the case without offering a definitive answer--and invite comments from you readers.

I can think of two ways in which the device industry differs in some basic way from the pharmaceutical industry. Please bear a couple of things in mind as I explain these two things. I am, by training and experience, a family physician. We family docs are not big-time device users. So I am left at a disadvantage in talking about this topic compared to surgeons, cardiologists, and other specialists whose bread and butter involves medical devices. Also please bear in mind that the end result of all this talk is supposed to be the benefit of the patient. We are not trying to rein in pharmaceutical industry influence, and get greedy docs to clean up their act, simply so we can all get gold stars in the teacher's grade book. We are trying to reform this system because of our conviction that at present, it is not serving the patient.

So, my nominations for how devices are legitimately different from drugs and so may mandate a somewhat different regulatory approach:

1. Several academic medical center policies that basically ban drug reps outright do not ban device reps, and I think that is justifiable. I don't need a drug rep on site to show me how the patient is supposed to swallow a capsule. Virtually all the information that I need to know about how to prescribe a drug could be provided to me in writing. For many devices this is not true. The company rep may be in fact a skilled engineer. Many devices need fine adjustments to work properly and the company staff may know much more about how to make these adjustments than anyone else in the hospital. And the adjustments may well require a hands-on demonstration if the physicians and nurses are to become adequately skilled at using the device.
2. Just as device reps have knowledge that physicians really need to take good care of patients, some physicians have knowledge that device manufacturers truly need to design the next generation of devices. In today's world, I doubt that a single drug is ever discovered or developed as a result of a practitioner calling up the drug company and saying, "I sure wish I had a drug that I could give my diabetic patients who have foot pain." The company's in-house scientists know far better than any practitioner what classes of molecules are out there that could become new drugs, and what bodily functions those molecules affect. But I assume that many medical devices are developed because, say,. an orthopedic surgeon calls up the company and says, "This artificial hip that you make is pretty good but I find it a bit awkward to apply the cement. Now, it dawned on me that if you modified the surface where the prosthesis attaches to the femur, the cement would go on a lot easier and you could have a much more secure attachment." (Or however they attach the danged thing--I have no clue.) So there is much more room for legitimate consulting between the company and a group of medical specialists in the device than in the drug case.

That said, there is one obvious and glaring similarity between gifts and consulting/speakers fees paid from device companies and drug companies to docs: at least some of these payments, if not the majority of these payments, are thinly disguised bribes to use the drug/device rather than an equally good drug/device made by a competitor company.

I would invite the executives of the device companies, if they want transparency and reform as much as some of them have said in Minnesota, to help legislators and regulators decide which payments are which. I also propose that medical professionalism remains an important part of the equation here because it is often the case that if there is a difference, the physician who gets the fee knows it--though the ability of physicians to go into rationalization-and-denial mode when their gravy train is interrupted is probably just as great on the device as on the drug side. Meanwhile I invite readers to comment at will.