Not only are current restrictions on the communication between pharmaceutical companies and patients poorly crafted, but they belie a larger professional prejudice on the part of physicians to inappropriately try to control and shape the release of medical information. Dr. Gottlieb debunks the erroneous facts and false assumptions on which he believes these misdirected impulses, on the part of the profession and legislators alike, are predicated.

Resident Fellow Scott Gottlieb, M.D.

I want to thank you Mr. Chairman for the opportunity to join this debate, and also thank the honorable member from the European Medicines Agency and the Honorable President of the European Parkinson's Disease Association in joining me in support of tonight's motion, that "this house believes that it is madness that pharma cannot speak to patients."

I intend to demonstrate that many of the current restrictions on information provided to consumers by pharmaceutical companies don't serve our public health goals very well.

I will argue that these restrictions are a symptom of a larger professional prejudice that we physicians harbor to inappropriately try to control and shape the release of medical information when scientific imperatives increasingly demand timelier release and more unfettered consumer access to health information.

I will show how, I believe, the restrictions we have imposed on the ability of pharmaceutical companies to provide consumer information are poorly crafted--that these restrictions are predicated on erroneous facts and false assumptions. I will focus the balance of my comments tonight on four of these misguided assumptions--the ones that I believe are the most prevalent and also most obstructive to public health progress. I want to start by briefly outlining these four assumptions, and then I will come back to them in more detail later.

First, there's a false belief that consumers are harmed by the kind of information that drug companies supply directly to patients. But in fact, there is ample evidence to suggest that this information--under appropriate approaches to regulation--can support public health goals.

Second, there's a belief that consumers couldn't "handle" the information--that they lack capacity to make effective, practical use of the health information, anyway. Again, not true.

Third, there's a mistaken belief that the information drug companies would supply is already easily accessible from more reliable sources. In other words, similar information is already available to consumers, so there's no reason to get the pharmaceutical companies involved in trying to provide it. Evidence shows, this isn't true. Consumers don't always have appropriate access to important health information about the products they use.

Fourth and finally, it's believed that the drug companies themselves cannot be trusted to speak directly to consumers through literature and promotional material. But there are models that demonstrate that this information can be properly regulated to support public health goals. For all the debate over the issue of drug company promotion taking place in the U.S., on balance the U.S. Food and Drug Administration has established a functional model for regulating direct to consumer drug advertising.

I intend to bring forth evidence to show that each of these assumptions is false, but I want to first frame my comments tonight with a perspective on why I believe these assumptions, and the ensuing restrictions on consumer information, have come to pass in the first place.

The bottom line is that the market for practical medical information that's available to consumers is inadequate. It's constrained by myriad of government rules. It's also constrained by the efforts of organized medicine, which has established its own restrictions, in too many cases for the profession's benefit and not for the primary benefit of patients.

It's these inclinations--the impulse to try and constrain and control medical information, and the view that information can be as harmful as it can be helpful--that forms the foundation of restrictions like those imposed on pharmaceutical company communications. Many of these restrictions are borne out of a paternalistic impulse among those of us working in organized medicine to try and control medical information--out of some noble but flawed intentions, but also out of traditions that only serve to promote established medicine rather than consumers. As doctors, too often we embrace restrictions on patient health information as a way to shape medical practice and even support our own professional expectations. But it doesn't serve the interests of our patients, and in the end doesn't serve our professional interests very well either.

That's a big charge, and I owe you some examples of those places where I believe our restrictions on information serve our professional needs better than they serve the needs of our patients. This is not a phenomenon that is exclusively confined to pharmaceutical promotion. The restrictions on drug company advertising are just the most visible, and--to the lay public--perhaps the least objectionable manifestation of this professional paternalism.

Take the medical journals. We all agree that they maintain a vital role in advancing the public health and developing and promoting good medical practice standards.

I worked on the staff of two leading medical journals. Most recently I worked as a medical news writer for the British Medical Journal. So I've seen firsthand how our premier medical journals play a vital role improving medical science and advancing the public health. But as modern, electronic tools make it easier to share information, the traditional and in many cases outdated publishing approaches of the medical journals can impede the exchange of medical opinion and bottom-line scientific results as often as they facilitate it.

I am talking first about the strict embargos that many journals maintain, and second their requirements for exclusive publishing rights that can prevent scientists from sharing results at professional meetings before they appear in print. These restrictions, like those imposed on pharmaceutical advertising, are borne of a similar desire to make sure that medical information reaching consumers and physicians has been carefully vetted by professional vehicles. There is value in this kind of careful scrutiny, but also an obvious downside.

Now I know that the exclusivity and the embargos also serve a second, even if an indirect purpose by increasing the economic value of the journal itself. After all, the restrictions ensure that there will be sufficient media and professional interest in bound journal editions that carry the bulk of the pharmaceutical advertising and paid subscriptions.

Now I don't want to see these important franchises suffer financially, but just like we need to re-think the restrictions we impose on pharmaceutical promotion, we may well need to consider new business models for the journals that allow them to capture the subscription and pharmaceutical advertising revenue that supports publication while pursuing timelier delivery of important findings. Right now, even when some journals web-publish a select number of the most "important" studies, these timelier publication routes are being used to serve institutional as often as public health interests.

A review of the studies that the New England Journal of Medicine chose to publish first on its web site over the past few years shows--by my count--that almost as many of these studies were aimed at injecting the journal into ongoing political debates as they were aimed at more timely reporting of seminal findings that would immediately change medical practice. This suggests that the reasons why the journals impose restrictions in the first place are as ambiguous to the journal editors as they are to me.

Medical journals are not the only professional organ that seeks to control medical information for practical reasons that I believe are nonetheless outdated in today's information environment and that conflict with the best interests of our patients. Consider, for example, the conduct of industry-funded clinical trials.

It is one thing for information from clinical trials of investigational, unapproved drugs to remain confidential owing to commercial reasons. There are fewer public health reasons why companies should be compelled to publicly release the results of studies with investigational drugs, even though it's true that most companies choose to share these kinds of results at scientific meetings. But it is quite another matter when the results involve clinical trials with a marketed drug that's being widely used. If a new study generates science that can help inform prescribing, it's an unmistakable fact that public health imperatives should trump commercial considerations and companies should be quickly making these results available.

In too many cases, the public health imperative to disclose information is compromised by corporate interests to use the selective or carefully timed release of clinical trial information to gain business advantage. Companies will realize in short time that the market for developing and sharing science has changed. They no longer can control medical information--even the information around their own products. Public health imperatives, as well as the realities of our information environment demand that companies consistently and expeditiously release the results from clinical trials that involve marketed drugs.

As another example of where the restrictions we physicians impose on the release and sharing of clinical information serves our professional interests better than it serves the needs of our patients, look no further than the activities of government health agencies.

Too often, the bottom line results from seminal government studies have remained bottled up as academic researchers pursued publication over the timely release of their findings.

Major findings from the Women's Health Initiative, for example, are still being unveiled in a sequence of carefully timed academic publications--more than five years after that data was first available to the research team.  Meanwhile, the bottom-line database from that government run, government-funded study has never been made available in its entirety to outside research groups, to the drug companies that manufacture and market the products, or even to the Food and Drug Administration, which is presumably in the best position to use the information to influence prescribing recommendations.

It appears that the pursuit of academic prestige and the desire to shape the interpretation of data through carefully planned publications has trumped a more fundamental mandate to make all of this information more widely and more quickly available to patients and doctors.

Ours is an era of medicine when the treatments themselves are becoming more individualized both to aspects of disease and to patients themselves. Patients are more sophisticated consumers of medical information. They are taking an increasingly active role in treatment decisions. In this environment, consumers need more information on which to base decisions.

Yet our professional vehicles too often maintain restrictions and practices that create informational asymmetries between government agencies and private medical institutions, between private medicine and individual doctors, and between doctors and their patients. In medicine and in healthcare there are those who have information--and as a consequence of restrictions that we as a profession have erected--very clearly those who do not.

These asymmetries are particularly harmful when it comes to patients' relationship to their medical care. Most medical information is technically complex and not easily understood by lay readers. Barriers to health literacy are compounded by the fact that many illnesses do not recur. So the cost of acquiring and assimilating the information is very high. Meanwhile, the costs of a mistaken choice are much greater and less reversible than in other aspects of life. It is also often difficult to postpone treatment and so virtually impossible to shop around. With imperfect information, it's hard to judge among different doctors' opinions anyway.

These informational asymmetries are also bad for the public health. They are bad for efforts to encourage patients to take a more active role in their health.

The information that pharmaceutical companies would share directly with patients cannot substitute for, or meaningfully shrink these asymmetries in information. That shouldn't be our goal in lifting restrictions on promotion.

But the restrictions that are imposed on the communication of medical information from product developers – in Europe, here in England -- are a piece of a larger impulse among health leaders to guard our professional prerogatives through the control of medical information. I think we need to see the restrictions on drug promotion not as an isolated policy decision but the result of this same professional arrogance when it comes to sharing the roots of our knowledge. For many doctors, the pharmaceutical promotion may be the least desirable and most annoying component of the pyramid of medical information. But far too often, we implement controls on every grade of medical information layered in that pyramid, from a superficial drug ad to a peer reviewed clinical study. We impose these constraints in ways that create substandard environments for educating patients.

I know that these restrictions are well intended. I know that many people in the medical establishment and inside government agencies and patient advocacy groups fear the impact that excessive and misleading pharmaceutical marketing information can have on patients. After all, lay consumers don't always have the resources or requisite training to adequately parse marketing slogans and carefully weigh risk and benefit information.

But the fact remains that all of the evidence shows that patients are helped by more and not less information about their medical options and that the information pharmaceutical companies make available, on balance, serves to advance public health goals.

When it comes to communications between drug companies and patients in particular, problems that arise from more unfettered access to information can be managed by effective regulation. Yet blanket restrictions persist here in Europe. Even in the U.S., despite robust constitutional protections and extensive FDA regulation, the legal nature of pharmaceutical promotion has come under scrutiny. Our present policies survive not out of popular support for the advertising, but simply because further restrictions on promotion would violate constitutional protections that are generally afforded to commercial speech.

As I said at the outset, I believe your bans here in Europe, and some of the desire in the U.S. to impose additional legal restrictions on pharmaceutical promotion, are predicated on four fundamental misconceptions. I want to get back to these false ideas, because they are wholly in concert with that broader professional impulse to take a paternalistic approach when it comes to medical information.

First, there's a prevailing view that consumers can be harmed by the information that drug companies would provide to patients.

There is no systematic evidence to support this proposition. In a properly regulated environment, where information is truthful and non-misleading, quite the opposite is true. The available evidence shows that consumers are helped by company provided materials.

For one thing, the information prompts consumers to seek care that they might otherwise forgo. One survey of 3,000 patients by Harris Interactive found that 35 percent sought medical advice after seeing an advertisement. Twenty-five percent of those patients received a new diagnosis and 45 percent of those diagnoses were for "high priority" conditions. 

A survey of 500 physicians that was conducted in 2004 by the U.S. FDA in order to gauge views on direct to consumer advertising found that when a patient asked doctors about a specific drug, 88 percent of the time they had the condition that the drug treated, according to the physicians surveyed.  And 80 percent of physicians believed that their patients understood what condition the advertised drug treats.

A 1999 survey of pharmacists conducted by the American Pharmacists Association reported a similar finding. That survey found that nearly seven in ten pharmacists (67 percent) believe, in general, that DTC advertising provides valuable information to patients. From their responses, it is clear that DTC advertisements initiate patient inquiries concerning health issues and possible medication treatments.

A second false assumption that inspires health authorities to seek restrictions or outright bans on pharmaceutical promotion to patients is the belief that consumers can't "handle" or make effective and practical use of the information companies would be inclined to provide.

But there is plenty of evidence to show that health literacy rates are increasing. In fact, lay consumers represent one of the fastest growing segments of new prescribers to the major medical journals. Web sites such as WebMD have built vast businesses by targeting medical information to patients. A study in 2004 of patients found that more than half of Americans said that they are active in their own healthcare. Thirty-eight percent look for healthcare information to make actual treatment choices.

Moreover, there is evidence to suggest that pharmaceutical promotional material improves health literacy, which in turn improves public health by focusing patients on recognizing the symptoms and progression of disease and on the importance of following appropriate treatment guidelines.

Health literacy deficits have been associated with worse healthcare outcomes, such as in diabetes mellitus.  Adult literacy has been shown to be a major factor in explaining health disparities among different groups of patients.  There is clearly demand among consumers for more health information and a demonstrated ability to appropriately interpret it.

A third false assumption invoked to support opposition to pharmaceutical promotion is that the information companies would provide is already accessible to patients.

But there is ample evidence to suggest that consumers not only lack quality information about disease awareness despite existing information sources and the Internet, but they also don't receive appropriate reminders on issues like medication compliance or education around recognizing the symptoms of worsening illness. These are the kinds of sustained messages that pharmaceutical firms are ideally suited and skilled at delivering. The FDA recognizes this by making sure that direct to consumer broadcast cads include risk information, even though patients can't get a drug without a doctor's prescription. It's because the FDA believes these messages are important sources of information about compliance and risk for consumers already taking the drug.

Data shows there is plenty of opportunity for better and more sustained information to address health problems. More than 25 million consumers remain undiagnosed and untreated for high blood pressure, and as many as 10 million for diabetes.

Whatever information patients receive, increasingly, comes from the Internet. A recent study by PEW found that 113 million Americans go to the Internet to find answers to health related questions. For 66 percent of them, their health inquiry began on a search engine.

Is anyone here prepared to argue that information retrieved off the Internet is more reliable than what extensively regulated pharmaceutical companies would provide?

Finally, there's a belief that companies cannot be trusted to speak directly with patients. If that's the concern, then I would ask why you dismiss the role for proper regulation to enforce bright lines around appropriate promotion that supports public health goals. This includes ensuring that companies don't low-ball risks and inflate expectations of benefit.

The FDA has regulated the advertising of prescription drugs since 1962, under the Federal Food, Drug, and Cosmetic Act and related rules. The regulations establish detailed requirements for ad content and the agency is currently updating its regulations.

Prescription drug ads must contain information in a "brief summary" relating to risks and benefits and "adequate provision" or consumers to get the full package insert. Advertisements cannot be false or misleading and cannot omit material facts. FDA regulations also call for "fair balance" in every promotional piece containing a product-claim. This means that risks and benefits must be presented with comparable scope, depth, and detail. Information relating to the product's effectiveness must be fairly balanced by information about its risks.

There are also economic concerns critics of pharmaceutical promotion raise. In closing, no discussion of this issue is complete without addressing these cost concerns head on.

It's true that drug promotion may pose one challenge to efforts to maintain control over healthcare budgets. After all, the ability to limit use of medical products, or deny reimbursement for expensive new medicines, is predicated on the ability to convince patients to forgo the benefits. Advertising to consumers is a challenge to these control regimes. It's also a challenge to busy schedules. Doctors report that they sometimes need to take extra time out of their patient encounters to address questions patients have from ads they saw.

These aren't very good reasons to control information in a way that leaves consumers less well informed. I believe the incremental cost containment that's achieved by slowing the flow of information about new therapies is vastly outweighed by the public health consequences of low rates of health literacy or awareness of illness and medical compliance. Ample evidence shows that pharmaceutical promotion, above all else, addresses each of these latter issues.

Pharmaceutical promotion can also help address gaps in knowledge about price and quality of drugs. Proper guidance from regulators can enable sponsors to include economic information in promotional material, and factual discussion about price, comparative effectiveness, and clinical value. Government officials are eager to increase patient awareness of these economic issues. Right now, the restrictions on the ability for companies to share this kind of information reduces their incentive to develop it in the first place.

The public health concerns that critics of pharmaceutical promotion raise are, I believe, vastly outweighed by the public health benefits that accrue from a more robust and competitive market for medical information. At the end of the day, the decision to prescribe a certain medication is a physician's alone.

Drug companies remain a deep-pocketed actor with the resources, incentive, and skill to promulgate health information. We should leverage this resource rather than placing blanket restrictions on their activities.
 
At a time when medical decisions themselves are more personal and complex, the opportunities people have to intervene to improve their health are more numerous. The avenues for doing so are more technically complex. These facts raise the stakes on the value of information, and the need to maximize every avenue to dismantle asymmetries of health information in order to improve awareness of illness and the ways to ameliorate it.

Scott Gottlieb, M.D., is a resident fellow at AEI.

Notes

  As described by the Women's Health Initiative Itself: "Recruitment began in September 1993 and continued through October 1998 for the [clinical trial]. Close-out of the WHI [clinical trial] occurred between October 2004 and March 2005" and "Scientists summarize new study findings for WHI participants as soon as they are available." The most recent study published by the WHI is: Tinker et. al. "Low-Fat Dietary Pattern and Risk of Treated Diabetes Mellitus in Postmenopausal Women: The Women's Health Initiative Randomized Controlled Dietary Modification Trial". Archives of Internal Medicine: 168(14): 28 July 2008. <http://archinte.ama-assn.org/cgi/content/short/168/14/1500> Accessed September 2008.
  Ed. By Taylor, Humphrey. Leitman, Robert. "The Impact of Direct-to-Consumer Advertising of Prescription Drugs on Consumer Behavior, Diagnosis, and Treatment". Harris Interactive: Health Care News: 3(11): 23 June 2003. <http://www.harrisinteractive.com/news/newsletters/healthnews/HI_HealthCareNews2003Vol3_Iss11.pdf> Accessed September 2008.
  As defined by criteria established by the Agency for Healthcare Research Quality.
  Aikin et. al. Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs." FDA: 19 November 2008.
  Kantor's MARS (Multimedia Audience Research Systems) Pharmaceutical OTC/DTC  2004 Survey
  Schillinger D, Grumbach K, Piette J, et al. Association of health literacy with diabetes outcomes. Journal of the American Medical Association. 2002;288:475-482.
  Sentell TL, Halpin HA. Importance of adult literacy in understanding health disparities. Journal of General Internal Medicine. 2006;21:862-866.
  http://www.pewinternet.org/pdfs/PIP_Online_Health_2006.pdf