Wednesday, July 06, 2005

Deconstructing Frist on DTC

Last week Senate Majority Leader Bill Frist, (R., Tenn.) shocked the pharma and advertising industries by calling for pharma to ban DTC advertising for new drugs for the first 2 years on the market (see "To Ban or Not to Ban DTC, That is the Question").

Frist, in his statement read on the floor of the Senate, cited quite a few studies and data about DTC. I thought it might be useful to reproduce parts of his statement here and deconstruct what he says to help provide further insight and balance.

-July 1st, 2005 - Mr. President:

Let me begin with a few phrases:
• “Keep the spark alive;”
• “The healing purple pill;”
• “If a playful moment turns into the right moment, you can be ready;”
• “For everyday victories.”

Turn on you TV – any time of day -- and that’s what you’ll see.
[What you won't see is Bob, the Enzyte guy. See "The Two Bobs: Enzyte vs. Viagra."]
Those are taglines for some of America’s best-selling, most widely advertised prescription drugs in recent years. We all know them because we’ve heard them over … and over … and over again.

We are barraged with them.
[That's called frequency in advertising. In order to drum the message into people these days, advertisers have to be much more repititious, or so the conventional thinking goes. People are just not paying as much attention to ads as they used to. Permission-based marketing may be a better solution that could have saved the industry from this type of criticism, if only they listened. For more on this topic, see "Out-of-the-Box Marketing: Will It Work for Pharma?"]
We’ve heard them on the television set and our favorite radio programs. We’ve read them in newspapers and weekly magazines. We’ve seen them on billboards along the highway and, yes, even on stock cars at our favorite racetracks.
[Here Frisk throws in a reference to Nascar in order to bond with "Joe Six Pack" voters. A calculated political gambit if ever I saw one. I don't know if there is a Purple Pill race car, but I think there is a Viagra one. As we get further into this analysis, you might begin to think Frist is pre-occupied with ER drugs. In any case, it is obvious that the ED ads have done great damage to the industry by pushing the envelope and offering themselves up as the archetypical DTC ads and easy targets for critics. For more on this topic, see "Are ED Ads Too Sexually Explicit"]
This is called “direct-to-consumer” advertising. It’s when drug companies market their products -- over the heads of doctors -- directly to patients and prospective customers.
[I object to the phrase "over the heads of doctors." It makes it sound like doctors unanimously oppose these ads.]
Now obviously there can be some health education benefits to such advertising. But let there be no mistake: drug advertisements fuel America’s skyrocketing prescription drug costs.
[Don't expect PhRMA to let that slide. See "PhRMA Statement on the Value of Direct to Consumer Advertising," which states: "Evidence does not link advertising and drug prices." PhRMA doesn't cite the source of this evidence, but what the heck, I'll take their word for it.]
They influence consumer behavior. And they influence physician behavior.

They cause more people to take prescription drugs. They create an artificial demand. And they drive up our nation’s overall health care costs. They needlessly and wastefully rive up your health costs.

Moreover, a lot of direct-to-consumer advertising misleads patients. It may oversell results. Or it may undersell the risks. Either way, misleading drug advertising hurts patients and definitely pressures doctors to over prescribe.
[There's a name for this type of specious argument. I'm too lazy to look it up. Everyone will agree with the conclusion of the argument: misleading advertising hurts patients. The problem is, Frisk just said that "a lot" DTC ads misleads patients and DTC "may" do this and "may" do that. He does not offer any evidence for the premises of his argument that leads to the conclusion.]
Today I urge all pharmaceutical companies to voluntarily restrict consumer drug advertising during the first two years that a new drug is on the market. Today I’m also requesting a government study of the costs, consequences and any potential benefits of direct-to-consumer advertising.
[A government study is always a good way to keep your name in the news or at least revisit the issue again and again.]
It’s time for drug companies to clean up their act. If they don’t, Congress will.
[Oh boy! How many times have I said that? I don't know. But I can tell you that the drug industry didn't listen.]
In its proper place, direct-to consumer drug advertising can empower consumers. It can give them information they need to make informed, smart decisions about their health. It can inform them about new therapies. These are good things.

Indeed, America needs a patient-centered health care system. Timely, accurate, complete, and balanced information must be a pillar of any such system. And advertising can help provide this information. But right now it simply is not.
[I'd have to agree with Frist on this point. See, for example, "Is DTC Educational or Motivational?"]
Today’s advertising leaves parents more often having to explain to their 10-year old children what erectile dysfunction is than how to prevent and treat high blood pressure.
[See what I mean about those ED ads being too good a target to pass up?]
So how did we get to this point?

Well, prior to the early 1980s, drug manufacturers almost always explained and introduced their products directly to physicians. Then, in 1981, Boots Pharmaceuticals ran the first U.S. print advertisement directed to consumers for its ibuprofen product, Rufen.

By the 1990s, drug companies began to use more print advertisements to promote their products directly to consumers. But they ran television advertisements only sparingly.

Since 1962, the FDA has required ads to include a brief summary of a drug’s side effects, indications for use, contraindications, warnings, and precautions. Massive changes began, however, when the Clinton administration liberalized the disclosure rules for televised ads in 1997.
[Blame it all on Clinton and those liberals! Later on Frisk does allow that Clinton was under intense pressure from the drug industry. Anyway, as I remember, Congress was controlled by the Republicans. The pesky liberals were blocked on many other issues, so why didn't the Republicans do something about this "liberalization" back then? Here, I believe, Frisk is establishing battle lines between himself and Clinton -- Hillary that is -- that will inevitably be drawn in 2008.]
Rather than providing a full picture of a drugs’ risks and benefits, the new laws required only that drug companies disclose the most significant risks and refer patients to a secondary source of information.
[The FDA has stuck to its guns about how risk should be conveyed in drug ads. That is, less is more. See, for example, "Can Drug Ads Communicate Risk?"]
As a direct result of the 1997 ruling, spending on direct-to-consumer advertising skyrocketed 145 percent between 1997 and 2001. It passed the $1 billion mark in 1997 and reached $2.7 billion by 2001.

In comparison, spending on pharmaceutical research and development increased by only 59 percent during this same period. Last year, pharmaceutical companies spent over $4 billion advertising medications directly to consumers.

Why? Because advertising sells drugs.

I believe the Clinton administration -- under intense pressure from the drug industry -- opened the door too widely. As a result, direct-to-consumer advertising exploded to levels that many could not have anticipated. And this has driven up prescription drug use and spending and, I believe, led to inappropriate physician prescribing.
[I think this is an attempt to rewrite history a bit and avoid having the Bush administration take a share of the blame. If anything, the 1997 FDA guidance give the industry an inch and they took a mile. BTW, if the FDA were more vigilant and less cozy with the drug industry, we wouldn't be talking about banning DTC today. See, for example, "The House(s) That Troy Built" in a recent post to this blog. Daniel Troy, former chief counsel to the FDA, was Bush's first FDA appointee. "Troy managed to restrict FDA's ability to use its statutes creatively, and this in turn deterred mid-level managers from advocating new approaches to emerging scientific issues, leaving the agency looking - and feeling - weak." (See "FDAers Think Troy Weakened Them, Worry About Masoudi").]
Consider the recent labeling changes and market withdrawals of non-steroidal anti-inflammatory drugs. These were among the most heavily advertised drugs in America. They were used by millions of patients. And many believe they may have been over prescribed.

In the case of Vioxx, 93 million prescriptions had been written since its approval in May 1999. And millions of prescriptions were also written for similar drugs, such as Celebrex and Bextra.

In the case of Vioxx, it did prove better than competing products for patients with stomach or gastrointestinal problems. Merck did conduct additional post-market research not required by the Food and Drug Administration. And, of course, we cannot foresee every risk.
[But the real issue here was not the risk vs benefit profile of the drug, but Merck's alledged obstructionism and attempts at damage control, doing all it could to divert attention away from the risk data while continuing to agrressively sell the drug. See, for example, "Who Should Pay for Merck's Obstructionism?" and "Get a Load of Those Gams".]
But, quite simply, we should always strive to make safety our top concern, particularly for newly-approved products used for the very first time in millions of patients. And doctors should have more time and more complete, balanced information to weigh the risks and benefits of a product.

In a 2002 report on the practice, the Government Accountability Office highlighted two studies. Each showed that a 10 percent increase in DTC spending within a drug class increased sales in that class by 1 percent. For one popular, heavily advertised prescription drug, one dollar of consumer advertising translated into four dollars in increased sales.
[This ROI estimate may be a tad high. For other estimates, see "eDetailing ROI Better Than DTC?"]
No wonder the drug companies flood our airways.

The GAO’s findings were clear: increased direct-to-consumer advertising has helped fuel escalating drug costs.
[I haven't read this report, but I'll give you my opinion anyway. The Summary of the report contends that there is a link between heavily advertised drugs and sales of those drugs. It doesn't provide evidence for a cause and effect link to prove that DTC helps "fuel" escalating drug costs. I think drug company shareholders and their Wall Street analysts are really the high-octane fuel behind rising drug costs. Nobody would consider banning selling drug company shares for 2 years!]
Drug costs are skyrocketing. In 2003, Americans consumed 134 billion prescription pills and spent over $216 billion on prescription drugs. This is as much as Americans spent on gasoline and oil. During the past few years, drug costs have gone up more than twice as fast as inflation-- faster than nearly all other health care items and services.
[An interesting statistic. If we pop over to the oil industry lobbyists, I am sure they could cite a statistic that Americans spend more on a gallon of bottled water than on a gallon of gasoline. From which one might say that we spend more on water than on drugs, and ergo, drugs are less expensive than water! What a bargain!]
Congress paid attention. And we acted. In 2003, we passed the Medicare Modernization Act. With President Bush, we took major steps toward providing more affordable prescription drugs:
[The following is the pitch for Bush. Let's just skip over that, OK?]
Congress took a good step in the right direction. But we clearly have more to do. And, as part of this effort, we must take a closer look at prescription drug advertising. Unbalanced and misleading prescription drug advertising hurts people. It adds tension to the physician-patient relationship. It leads to inappropriate prescribing. And it overwhelms our current regulatory system.

Let me begin with consumers. We are all too familiar with these ads. They adorn the pages of major magazines, websites, and newspapers. They flood the airwaves. And, particularly on television, they present a parade of upbeat images, but offer warnings and cautions only as an afterthought.

Just think, how many parents have found themselves watching a sporting event with their son or daughter only to be assaulted by an ad for an erectile dysfunction drug? Advertising during last year’s Superbowl comes to mind.
[Back again to the ED ads. I'm beginning to think Frist is a bit obsessed with these ads. I also have written about them to expose how they are hurting the DTC cause. See, for example, "Super Bowl DTC Debut: Was It Good for You?" and "Marketing Drugs Like Packaged Goods at the Super Bowl"]
Also, only rarely do these ads provide consumers with enough time to absorb important risk information.

According to a 2002 FDA survey, nearly 60 percent of patients reported that drug advertisements don’t provide enough risk information. And 58 percent of patients felt that ads portray products as better than they are.

In a separate 2002 FDA survey, 75 percent of physicians said that ads led patients to overestimate the efficacy of the drugs. And 65 percent of physicians noted that patients confuse the risks and benefits of drugs advertised to consumers.
[The study also showed that DTC advertising, when done correctly, can serve positive public health functions such as increasing patient awareness of diseases that can be treated, and prompting thoughtful discussions with physicians that result in needed treatments being prescribed - often not the treatment in the DTC advertisement. This study also demonstrates that most physicians view DTC advertisements as one of many factors that affect their practice and their interactions with patients, both positively and, in some respects, negatively. See "Results from FDA Physician Survey on DTC Advertising".]
This means that sometimes a patient may request or even insist upon a drug that does more harm than good. They may rely too heavily on a pill when overall lifestyle changes are called for. They may demand the latest, expensive medication when an old standby may do just as well.

And patients, seeing the ads, place new demands on their doctors. My medical colleagues are pressed for time. Driven by the drumbeat of advertising, relentless pressure to contain costs, and the understandable desire to please their patients, some harried physicians write unneeded prescriptions rather than arguing with their patients or explaining why a less expensive drug would be just as effective.
[Shame on them, I say. See "Blame the Doc, Not DTC!"]
As example -- after one year of directly advertising the bone-mass-increasing drug Fosamax to consumers, physician visits for osteoporosis evaluation nearly doubled.

This is a good example of why direct-to-consumer advertising is a double-edged sword: Those additional visits indeed helped some find needed treatment, but did these ads provide patients with useful information when discussing it with a physician?

In a recent study from the University of California-Davis, researchers sent actors in good health to 152 doctors’ offices in three cities to find out if they could get prescriptions for simulated symptoms. Half of the actors imitated patients suffering from depression. The other half expressed symptoms of stress and fatigue.

The study found that if an actor requested Paxil, a heavily promoted antidepressant, he was five times as likely to walk out of the doctor’s office with a prescription for the drug. The research suggested that direct-to-consumer advertising increases patient demand for specific medications, even in situations where the prescriptions aren’t needed.
[I have a problem blaming DTC for poor medical practice, which is what I think this study really reveals. See "Blame the Doc, Not DTC"]
Finally, we need to ask questions about how we regulate prescription drug advertising. Right now, the FDA has neither the resources to scrutinize direct-to-consumer drug advertisements nor the power to review them for accuracy before they are viewed by the American public.
[The Bush administration has to accept some responsibility for this, in my opinion.]

The FDA simple can’t keep up. And our failure – our government’s failure -- to appropriately regulate drug advertising hurts the very people drugs are intended to help -- patients. We are not serving the American people as well as we should – or can.

Two weeks ago, the pharmaceutical company Bristol-Myers Squibb announced a voluntary ban on advertising its new drugs to consumers in their first year on the market. The company said it wanted to give doctors more time to understand new products before patients start asking for them.
[See "New DTC Principles Emerging" for more on this.]
This shows leadership and responsibility. Bristol-Myers Squibb sets an example of restraint in an industry that needs it more than ever when it comes to advertising.

But this cooling off period may not be enough. PhRMA, the drug industry’s trade association, has announced it will adopt an industry-wide voluntary code governing direct-to-consumer advertising next month. This is another good move.

I believe this should, at a minimum, include a voluntary restriction on the direct-to-consumer advertising of prescription drugs in their first two years on the market.

Why this restraint? A typical clinical trial for a drug includes roughly 5,000 patients. A blockbuster drug can attract more than a million users during its first year on the market. But no drug is free of side effects. It often takes years before scientists get a complete picture of a new drug’s effects.

Both doctors and patients need time to learn about new treatments, assess their benefits, and find out more about their risks. A full knowledge base of the potential side effects takes time to develop. Education should always come before persuasion. Patient safety should be paramount, not the bottom line.
[Frisk sounds positively populist here -- well beyond liberal even. Will the pharma industry and its representatives now accuse Frisk of being against free enterprise? Perhaps this is another example of "creating a war of 'liberal idealism' versus 'profit hungry big business' " See "Separation of Church and State."]
If these voluntary restrictions don’t do the job, I believe Congress should act.
[Look out for a pre-emptive first strike!]
Three additional steps should be considered. Some may require legislation. Others could happen through voluntary work by the drug industry – which I would encourage.

First, we should give the FDA prior review and approval authority for all direct-to-consumer drug advertising.

By the time the FDA reprimands a company for running a misleading drug commercial, that advertisement may have already deceived consumers. Advertising should boldly and responsibly address safety head-on, replacing upbeat, fantasy-land images with a frank discussion of a product’s benefits and risks.
[For an idea of how the industry can do this, see "DTC Straight Talk," which discusses a J&J approach.]
Second, we should increase resources devoted to reviewing advertising to determine its accuracy and to ensure all standards are met.

The FDA – to whom we have given this responsibility -- must have the capability and resources to more thoroughly monitor drug advertising and make absolutely sure that companies comply with advertising guidelines.

The American people assume this is being done – and it is not.

A staff of 40 simply isn’t enough to get the job done. We should explore ways to make sure that adequate resources are devoted to this problem, so the FDA may appropriately and adequately act before a misleading advertisement influences the behavior and health decisions of the consumer.

Third, we should give doctors and patients greater access to clinical data and post marketing surveillance efforts about drugs after they become available.
[See, for example, "Proposal for a Drug Risk Advisory System"]
For the drug industry which has long touted the educational mission of its ads, it must know that the success of their mission inherently depends on the quality of information provided to physicians and patients – not just the enticing images.

While we can’t foresee every risk, the industry has a responsibility to provide physicians and patients with balanced information regarding a drug’s risks and benefits.

As a doctor who has witnessed both the good, but especially the bad, in this explosion of drug advertising, I will be watching this issue closely. And if the pharmaceutical industry’s voluntary restrictions aren’t strong enough, I’ll support Congressional action to make sure consumers get the protection they deserve.

In the meantime, today I’m asking the Government Accountability Office (GAO) to investigate the FDA’s oversight of prescription drug advertising, the pharmaceutical industry’s spending on such advertising, and this advertising’s impact on utilization, health care spending, and patient education and awareness.

Wherever I travel -- whether I’m at the Coca Cola 600 in North Carolina or at Harvard Medical School in a roundtable discussion with doctors -- people ask me about health care costs and access to affordable, quality care. They come back again and again to the pitfalls and the loss of direction of DTC advertising.

I believe that we must move towards a health care system that puts the patient at the center and in control. And, above all, one that controls costs for the American people.

I know my colleagues share these same priorities. I believe the steps I propose will save money. But, even more importantly, they will save lives.

Prescription drugs rank among the most powerful tools in medicine. We could not and should not do without them. But we must use them—and market them—with care.

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