A week or so ago we blogged about comments Prescription Access Litigation and others made to the FDA in support of proposed rules on presenting risk information in broadcast drug ads.
Numerous other consumer and public health groups have commented, and overall offered resounding support for these proposed regs. The Patient, Consumer and Public Health Coalition offered their support for these regulations and stressed that “the goal of DTC ads is to persuade, not to educate, and so DTC ads emphasize the benefits but not the risks of prescription drugs.”
Consumer groups, including the National Consumers League, additionally offered support for the proposed fifth requirement of dual-modality, simultaneous audio and textual presentation. Consumers Union voiced the importance of dual-modality in their comment stating that “[p]roviding an audio warning with other things happening in the background is, no matter how hard one tries, distracting” and, “[p]roviding a text warning while talking about other things is distracting;” “Providing the same, simultaneous audio and visual warning is the single best way to make a lasting impression that will be helpful to patient-consumers.”
Some consumer groups also argued that pre-review of ads should be required. Here’s Public Citizen: “to obtain approval of DTC advertising on broadcast media, a party shall present market research demonstrating that information concerning side effects, contraindications and warnings is comprehensible to the target audience.” A pharmacists group and pharmaceutical powerhouse Eli Lilly also supported the use of focus groups to review and “pre-approve” ads and to pilot test that elements (e.g. font size, color, placement) of an ad.
In addition to these shared themes, AARP also suggested that the FDA rule should specify where in the ad the “major statement” should appear” and that the major statement should not be allowed to be placed in the middle of the ad “where it can be bookended by conveyance of benefit information and is least likely to be retained by consumers.”
The two pharmacist organizations that commented–the American Society of Health-System Pharmacists and the Academy of Managed Care Pharmacy (AMCP)—supported the new proposed rules, as well as dual modality in ads and pre-dissemination review whether by the FDA or by consumer test groups.
Industry against dual modality, for delays
Industry was relatively quiet on these new proposed regulations: only the Pharmaceutical Research and Manufacturers of America (PhRMA) and four pharmaceutical companies submitted comments so far. Though industry all stressed the public health benefits of DTCA and generally offer their support for the FDA’s action to further clarify the standards, a few common themes of opposition are apparent in all industry comments.
On the whole, industry seems very opposed to the proposed fifth standard of requiring dual modality. Sepracor argues that dual modality “could prove to complicate the presentation for consumers.” PhRMA seconded this argument and said that “dual modality might produce presentations that actually overemphasize risk information.”
Merck further stated that dual modality “does not improve consumer recall or understanding of important risks information.” Though Merck supported this argument with one 2005 study, it went on to mention the limitations of this study and none of the other industry commenters provided any support for their arguments against dual modality, and all of industry’s comments against dual modality ignore the numerous studies that have shown that the technique enhances clarity and recall of information (and which the FDA cited in its proposed rule).
The second overarching theme of the industry comments seems to be an attempt to delay the implementation of these rules. Sepracor, Merck and Eli Lilly all suggest that the FDA do further research and analysis on these standards before implementation. Sepracor argued that the rule should not be made effective until the results of FDA’s study on the impact of distraction can be published and commented on.
This argument reads largely as a delay tactic employed by Sepracor to postpone the inevitable implementation of this rule. Though there is no doubt that the FDA’s study may help them to further understand what elements of broadcast media can be distracting, there’s little debate that the impact of distraction on consumer understanding… is to distract, and that’s hardly a reason for FDA to delay implementing these rules when the public’s health is at stake.
In one of the more head-scratching unsupported assertions, Sepracor stated that up to 70 percent of the time slot of an ad is used to convey safety information for the drug. Anyone who’s ever viewed one of the numerous DTC ads currently on TV knows that this statistic has little foundation in reality.
Last week, the American College of Physicians (ACP), a 129,000-member group of internal medicine physicians, and second-largest doctors group in the US, called for increased FDA authority and funding to help protect consumers from the risks of newly-approved prescription drugs. Their six recommendations were:
1) increased funding for FDA staff and technological capability to keep pace with the increased workload due to the number and scientific complexity of new products submitted for pre-approval, globalization, and emerging safety challenges.
2) increased FDA authority and capacity to regulate drugs manufactured outside the US;
3) expanded FDA authority and involvement in the design of clinical trials to better evaluate safety and efficacy, through longer trials with larger, more representative target populations;
4) a ban on clinical studies of ‘bundled’ drug products that reduce access to drugs;
5) Improvements that increase reporting of adverse events by doctors and others; and
6) limits on direct-to-consumer advertising in the first 2 years a drug is on the market.
Increased FDA funding:
The ACP report notes that FDA’s “ability to approve and monitor new drugs has been compromised by chronic underfunding, limited regulatory authority, and insufficient organizational structure.” ACP recommends that FDA funding is increased, to improve their “ability to approve and monitor prescription drugs….”
Regulating drug manufacturing overseas:
The ACP should be praised for bringing attention to severe under resourcing at FDA, particularly as it affects the Agency’s ability to ensure the safety of drugs manufactured overseas. Today’s globalized pharmaceutical supply chain has rapidly outgrown FDAs capacity, and FDA is not able to inspect foreign sites with any meaningful frequency. A 2008 GAO study found it would take FDA 13 years to inspect each foreign manufacturing establishment once, while domestic sites are inspected on average every 2.7 years.
ACP points out that a provision for increased foreign inspections were included in a bill (H.R.759) introduced by Reps. Dingell, Pallone and Stupak in January this year. A similar bill (S.882) championed by the late Senator Kennedy and Senator Grassley also seeks to increase foreign site inspections by FDA. Both bills establish new industry user fees to pay for this expanded oversight, but also require annual increases in other appropriations to ensure sustainability. ACP importantly indicates that both types of financial support are needed, and mentions a number of other key provisions in the House bill, including a requirement for dedicated foreign inspection staff.
Facilitating increased physician reporting of adverse events:
The ACP also recommends FDA pursue efforts to “educate physicians on how and when to report an event that is potentially drug-related.” They also proposed streamlining the reporting systems and ensuring anonymity to “facilitate reporting by health professionals.”
DTC advertising of new drugs:
The report acknowledges that direct-to-consumer (DTC) advertising can “dramatically increase [use] of a new drug and … may expose large numbers of people to a drug with undocumented safety concerns.”
The best example of this concerns was seen in the rapid use of the pain-killer Vioxx upon hitting the market. The aggressive DTC advertising and other promotional activities by manufacturer Merck lead to Vioxx’s use by over 20 million consumers, which then lead to 88,000-139,000 cardiac events, and an estimated 35,000-55,000 deaths. Adverse reactions and safety concerns arose with the drugs Zyprexa and Bextra, among many others
To address this concern, ACP recommended that FDA ‘limit’ the DTC advertising of newly approved prescription drugs, and require that labels and ads indicate that data related to the new drug’s “risks and benefits … are less extensive than those [for older] products…”
Prohibiting clinical trials of ‘bundled’ products:
In addition, ACP also makes a recommendation that would help FDA avoid placing itself in the position of helping drug manufacturers introduce ‘bundled’ or combination drug products designed to protect a drug from generic competitors.
For example, the report describes how, in 2005, the drug manufacturer “Pfizer submitted plans to the FDA to begin conducting large trials to test the cholesterol drug torcetrapib in combination with the popular and widely used statin Lipitor.” By allowing clinical trials of the ‘combination drug’ rather than just torcetrapib alone, approval of the new combination drug product would insulate Lipitor from competition. This then puts FDA, in approving the study design, in the awkward position of helping the drug manufacturer avoid anti-trust prohibitions, the report said.
This concern is similar to the claims in the PAL member lawsuit on the drug Norvir, where drug manufacturer Abbott Labs bundle their HIV protease inhibitor cocktail drug Norvir in a new bundled-product-drug Kaletra, in order to increase market share.
ACP recommends that FDA not approve clinical trials which seem to be designed to ‘bundle’ a new drug with an existing brand name drug, and thus perpetuate the patent-protected sales of the new combination product.
As we reported back in August, (Abbott and plaintiffs agree to proposed Norvir settlement), Abbott Laboratories (NYSE:ABT) and plaintiffs who brought a nationwide class action challenging Abbott’s 400% price increase on its HIV/AIDS drug Norvir agreed to a settlement of between $10 million and $27.5 million. Under the settlement, the amount that Abbott would have to pay would depend on whether the Ninth Circuit Court of Appeals accepts an appeal of certain key issues in the case, and how that Court ultimately rules on those questions. For a full description of the different scenarios, and amounts that Abbott would have to pay, see the earlier post here.
Yesterday, the Ninth Circuit Court of Appeals issued an order accepting the appeal. This allows the settlement process to move forward, although how much Abbott will have to pay will remain up in the air until the Ninth Circuit issues its actual decision on the appeal.
Recently, the FDA requested comments on direct-to-consumer (“DTC”) advertising, and its effects upon subsets of the general population, such as the elderly, children, and racial and ethnic minority communities.
PAL and our sister organization, the Prescription Project (www.prescriptionproject.org ) weighed in on the relationship between DTC advertising and the risks and costs of prescription drugs. Our assessment overall was that
“direct-to-consumer advertising produces no proven public health benefits and likely plays a role in driving unnecessary use of pharmaceuticals. Manufacturer-sponsored television advertisements, in particular, are ill-suited to effective communication of risk-benefit information about prescription drugs. Elderly consumers, the less-educated and those with English as a second language may be at particular risk for misunderstanding the potential risks and benefits associated with advertised drugs.”
First, we noted that there is evidence that DTC ads prompt people to discuss advertised conditions and treatments with their doctors – in short, DTC ads work. Why else would the drug companies spend increasing billions each year on drug ads. But, more importantly, we point out that there is no evidence that what ‘works’ to sell drugs is of any benefit for patients. To the contrary, there is abundant evidence of the harm and cost of DTC advertising to consumers.
Populations at risk.
Drug companies tend to focus their advertising on new drugs, with the hopes of finding the next billion-dollar block-buster. When successful, ads drive a rapid increase in prescribing that can expose a large number of the public to the health risks and previously-unknown side effects associated with the new drug. (Clinical trials of new drugs that drug companies run as part of getting FDA approval usually involve only a few thousand participants for a short time, usually less than two years. Therefore side effects that are rare, or that emerge only after patients have used a drug for a longer period of time, may only become obvious once the drug is on the market for a while and being taken by millions of people.)
Vioxx: The Poster Child for Drug Usage Driven by Advertisements
Developed as a daily-use pain reliever, Vioxx was no more effective than ibuprofen (Advil) or naproxen (Aleve). Its only established improvement over these older, time-tested (and much cheaper!) medicines was a decreased risk of stomach bleeding and ulcers. However, no more than 2-4% of patients are at risk for developing these stomach problems. As a result of the substantial DTC advertising and other aggressive promotion, Vioxx use soared from 1999 until its recall on September 30, 2004. Our comment notes that the rapid explosion of Vioxx use, made possible in part by DTC advertising, was
“responsible for an estimated 88,000 to 140,000 cases of serious coronary heart disease and an estimated 38,000 to 61,000 deaths in the USA.”
Even without these risks, DTC advertising drives up health care costs. DTC advertising promotes medically unnecessary prescribing that offers “little or no meaningful clinical benefit for many patients….” This is true of cholesterol lowering agents, allergy medications, antidepressants, and many other types of heavily advertised drugs.
For instance, we noted one study in which actors went to doctors offices posing as patients, and specifically asked for Paxil after supposedly seeing an ad. Doctors wrote prescriptions for Paxil in very high percentages even when the purported condition was one for which there was little evidence (minor depression), or even no evidence (social adjustment disorder) that Paxil was an effective treatment. This illustrates how DTC advertising helps fuel medically inappropriate use.
Debunking drug industry propaganda that DTC advertising promotes public health
In our comments, we took the opportunity to review the many other submissions to the FDA by drug companies which claimed that DTC advertising promotes public health. We noted that most of their purported ‘proof’ were ‘opinion surveys’ of how doctors or patients felt ads helped lead to needed diagnoses or treatment. Only one cited study looked at how often ads lead a patient to seek diagnosis. But we noted that there were no studies proving that DTC ads actually lead to objectively measured, medically necessary and appropriate care.
DTC advertising is not balanced
Under federal regulations, promotional materials for prescription drugs must achieve a ‘fair balance’ between showing the benefits of a drug, and its risks. Also, promotional materials must provide adequate warning of the possible risks or adverse side effects.
The heart of the problem with direct to consumer advertising is that it does not achieve this ‘fair balance.’ DTC ads have been shown to focus more on the benefits, and to downplay or undermine the viewer’s understanding of risks. As a result, one study found that patients can accurately describe the benefits of drugs 80% of the time, but can only understand the risks 20% of the time. This is because drug ads spend more time describing a drug’s benefits, using easier language, with frequent repetition. In contrast, drug risks are often presented more quickly, in more difficult language, with other audio and visual distractions.
Our conclusion
We recommend that FDA closely examine whether DTC ads can or do achieve a ‘fair balance’ between benefits and risks, given the ads representation of, and the public’s perceptions of, these risks. In addition,
“it must be remembered that DTC advertising drives attention to conditions chosen for their return on investment, not their importance in improving the public health.”
PAL’s and Prescription Project’s comments are here.
The FDA Amendments Act of 2007, also known as FDAAA, as in “open wide and say FDAAA,” is a riveting 156-page read, and buried in its contents is a provision, known to its friends as 121 Stat. 890 Sec. 502(f)(1), that requires drugmakers to include a toll-free number in print advertisements for prescription drugs, for consumers to report adverse effects or negative side effects from those drugs.
(The FDA published a notice in the Federal Register on January 3, advising that the rule went into effect on January 1, 2008. Interestingly, although it says the rule goes into effect January 1, that doesn’t mean that all drug companies must comply with the rule by January 1 — the Federal Register notice says “In the preamble to the toll-free number proposed rule, the agency proposed that all manufacturers, dispensers and
pharmacies subject to the rule be in compliance not more than 1 year after the effective date of the final rule.” I guess only at the FDA does “in effect on Jan. 1, 2008″ really mean “in effect one year later than Congress required.”)
But what about TV ads? There’s no requirement that drugmakers include that toll-free number in their television ads. And no doubt drug companies wouldn’t want that requirement. Can you imagine a drug ad that said “Side effects may include bloat, foaming at the mouth, heart attack, hives, hallucinations, insomnia, excessive sleepiness, erections lasting longer than 4 hours, and compulsive gambling. Call 1-800-FDA-1088 if you experience any negative side effects while taking this drug.” That certainly would tend to, um, accentuate the negative, if you will.
But having these toll free numbers on TV ads is arguably far more important. It’s impossible to watch prime time TV without seeing several drugs an hour. People spend far more time watching TV than they do reading magazines. Drug companies spent twice as much on TV ads on Network and Cable TV in the first half of 2007 (nearly $1.6 billion) as they did on national magazines, sunday supplements and newspapers (just over $838 million). [Source: DTC Perspectives, "Spending Review," December 2007]
There’s a bevy of opinion pieces and articles about drug marketing in the news today, mostly in the wake of the “Jarvik-row-gate,” the scandal concerning Dr. Robert Jarvik, Lipitor pitchman, being neither a licensed physician nor a practicing rower. We blogged on this story here and here.
Here’s a roundup, saving you the time of actually having to go read these pieces yourself. We aim to please here at the PAL blog.
In the Chicago Tribune today, Katie Watson, acting associate director of the medical humanities and bioethics program at Northwestern University’s Feinberg School of Medicine, opines about “a terrible disease — physician addiction to drug money.” She cautions against overfocusing on Dr. Jarvik and his lack of prescribing and rowing credentials, and recommends instead that “Congress should use his Lipitor endorsement as a catalyst for reviewing the larger issues it raises.”
She raises a point that we here at PAL and others have made in the past: That pharmaceutical advertising, nay, medical advertising in general, improperly turns “patients” into “consumers:”
Pharmaceutical advertising is a good place to start. This is typically called “direct-to-consumer” advertising, and the committee’s letter to Pfizer says it’s concerned that “consumers” may misinterpret Jarvik’s health claims. But consumers can’t buy prescription drugs, only patients can. Patients are people who make decisions with expert partners; consumers roam grocery stores picking cereal alone. Once patients were recast as consumers, prescription drugs could be advertised as if they were tennis shoes. It was just a matter of time before a celebrity pitchman turned a drug like Lipitor into Air Jarvik.
The pharmaceutical industry uses advertising to pull patients away from physicians — come in with your mind made up, and your physician is reduced to prescription writer. The industry undermines the other side of the patient-physician partnership by throwing money at physicians. This half of the divide-and-conquer strategy usually happens behind the scenes, but Pfizer’s partnership with Jarvik for mutual profit makes a widespread practice visible.
Business Week hosts a “debate” on the topic of “Halt the Pharma Freebies.” On the “Pro” side to ending pharma trips, meals and gifts is Dr. Philip A. Pizzo, from Stanford University Medical Center. He recounts Stanford’s adoption of policies in 2006 seriously restricting pharma access to doctors in the hospital:
In October, 2006, we enacted a policy across the Stanford University Medical Center campus, prohibiting our faculty members from accepting gifts of any kind, however small, anywhere on the medical campus or at off-site facilities where they may practice.
It also bars industry sales and marketing representatives from wandering the hallways of our two hospitals and our laboratories, and prevents companies from directly paying for meals in connection with educational programs—once a fairly common practice. It requires that those involved in the decision to buy formulary drugs or clinical equipment disclose any related financial interests….
Since our policy went into effect, many other academic medical centers have followed suit. As we train the next generation of physicians under these new standards, we will sow the seed for what could be a wholesale cultural change in the U.S. medical profession.
Our colleagues at The Prescription Project are working with numerous other academic medical centers to adopt policies similar to Stanford’s. They author the very fine blog, PostScript.
On the “Con” side is Ken Johnson, from PhRMA, who has the unenviable task of defending his industry’s positions. Unfortunately, his arguments fail to stray from the now-very-tired PhRMA playbook, and fly in the face of quite a bit of documented evidence.
So, despite what critics say, it’s insulting to suggest that doctors would prescribe treatments based on who gave them a slice of pizza, a pen, or a medical dictionary.
It might be insulting, but it doesn’t make it not true. Numerous studies document that even small gifts affect prescribing. (See, e.g. Physicians and the Pharmaceutical Industry- Is a Gift Ever Just a Gift? in JAMA from 2000. See also here for many more studies documenting this.) This is not a conscious quid pro quo (”Gee, that pizza the drug rep brought sure was good. I think I’ll prescribe her drug to the next patient I see.”) but rather a subconscious engendering of good feeling and goodwill. We are all prone to it, whether we went to medical school or not.
What’s more, there are regulations and a comprehensive industry ethics code to help make sure information about new treatments provided by America’s pharmaceutical research companies is accurate and well-substantiated.
To which I can only say, Ha. One need only browse the boards at CafePharma to read numerous tales of the thwarting, skirting and even outright ignoring of said regulations and codes of ethics.
Existing federal law is very clear: Pharmaceutical research companies and their technically trained representatives, including some health-care professionals, must not give physicians anything of value in exchange for the doctors writing prescriptions for their medicines. The companies must also ensure that information they convey to physicians is consistent with pharmaceutical product labeling approved by the Food & Drug Administration. The fact is, federal and state authorities, including the FDA, the Justice Dept., and state Attorneys General are closely monitoring for improper activities.
And guess what? That monitoring, and the work of brave qui tam whistleblowers, has brought to light countless examples of widespread improper activities in the past few years. Which suggests that perhaps, methinks, compliance is not fully robust.
For its part, the Pharmaceutical Research & Manufacturers of America (PhRMA) sponsors ethical guidelines to keep communications between its member companies and physicians focused on proper use of medicines and the needs of patients. The PhRMA ethics code says all forms of entertainment are inappropriate and only modest meals—such as sandwiches—should be provided when doctors meet with pharmaceutical research companies. Additionally, our code says items given to physicians should not exceed $100 in value and should be things, including stethoscopes and medical dictionaries, that benefit patients or support a medical practice.
Ah, voluntary guidelines, the pharmaceutical industry’s favored method to forestall true regulation and enforcement. These guidelines are not binding (except in California, which by legislation adopted them as state law), and there’s no enforcement for violations. PhRMA and their members liked these unenforceable physician gift guidelines so much that they used the same approach for drug advertising in their “”Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines.” These guidelines earned PhRMA one of PAL’s coveted “Bitter Pill Awards” in 2006: The Fox Guarding the Henhouse Award: For Pushing Toothless “Guiding Principles” on Drug Advertising.
In the end, it’s clear pharmaceutical research companies have the most extensive information about new medicines. After all, they devote 10 to 15 years and spend nearly $1 billion to develop just one new medicine in a process that generates thousands of pages of scientific data.
They also have the greatest incentive to “spin” their drugs, by withholding negative information and clinical trial results (ahem, Zetia/Vytorin anyone?), by pushing on doctors medical journal articles that show their drug only in the most favorable light, etc. And PhRMA, please stop trotting out the tired $1 billion figure for new drug development. Merrill Goozner handily refuted that myth in his book The $800 Million Pill (back when PhRMA was only claiming it cost $800M for a new drug) and continues to do so on his excellent blog GoozNews.
Over at HOI-19 News (an ABC affiliate), there’s a story called “Drug Pitch Police.” It begins by reciting, mostly unquestioningly, PHrMA’s claims about drug marketing and the costs of drug development, but then gives a description of the Independent Drug Information Service (IDIS), a program that is providing “counter-detailing” or “academic detailing” to physicians in Pennsylvania. These “academic detailers,” mostly nurses and pharmacists, provide a vital counterbalance to the self-serving and slanted messages of the drug company sales reps. They provide doctors in PA with information about the true effectiveness and cost-effectiveness of various drugs, in order to both reduce costs to Pennsylvania’s Medicaid program and improve treatment.
The Roanoke Times has an editorial today calling on Congress to “Pull the Plug on Drug Ads.” It talks about the House Committee on Energy and Commerce looking into Dr. Jarvik’s bona fides and says, among other things:
The committee is compiling information and will most likely head on down the rabbit hole of “celebrity endorsements.” Instead, it ought to be looking at the bigger picture: It is unwise to allow pharmaceutical companies to continue direct marketing to consumers whether they feature Jarvik or a next-door neighbor…The House committee should be persuaded to go much further than looking at deceptive marketing and, instead, renew the ban on marketing to consumers.”
That’s it, folks, a busy day for those holding forth on drug marketing. What do you think? Good points? Bad points? Beside the point? Let us know in the comments.
On Feb 6, David Lazarus, writer of “Consumer Confidential” for the Los Angeles Times, wrote an article on drug advertising, “Ads spur urge for drugs“. The article didn’t break any new ground in its analysis of how drug ads spur people to ask for drugs they may not need, but was a good overview of the issue.
Lazarus focused on a new Direct-to-Consumer ad campaign for Provigil, which originally was approved by the FDA to treat narcolepsy and is now also approved to treat “excessive sleepiness associated with obstructive sleep apnea.” The ads claim that Provigil can “fight the fog.”
Lazarus reports this telling exchange:
Jenifer Antonacci, a Cephalon spokeswoman, said the new DTC campaign is merely intended to raise awareness about excessive sleepiness.
“We’ve decided to take a leadership role in this area,” she said. “Our goal is to help educate consumers about excessive sleepiness and start a dialogue between patients and their physicians.”
While Provigil is being marketed as a remedy for fatigue resulting from sleep apnea, it’s not hard to imagine on-the-go people in today’s 24/7 world seeing the drug as a nifty way to cram a few more hours of wakeful activity into already crowded days.
Why settle for a venti latte at Starbucks when you can get the same kick (and possibly more) from a little pill?
Antonacci described a potential Provigil user as someone who repeatedly finds himself nodding off on the couch while watching TV at night.
“That’s me!” I responded.
“Maybe you have sleep apnea,” Antonacci observed.
So don’t be surprised if a lot of consumers who now ask their doctors about Provigil don’t have obstructive sleep apnea, shift work sleep disorder or narcolepsy, the only three conditions for which using Provigil to treat “excessive sleepiness” is approved. And don’t be surprised if those doctors write a prescription for those patients anyway:
Some doctors I’ve spoken with say they’ll suggest generic equivalents or alternative approaches. But if patients are determined to try a name-brand drug they’ve seen pushed on TV or in the paper, it’s often not worth the trouble trying to talk them out of it.
And studies bear this out. When patients ask their doctors for drugs they’ve seen on TV, doctors will prescribe them in much higher numbers than if the patients didn’t ask for an advertised drug by name. See, for instance, a study published in 2005 in the Journal of the American Medical Association: Influence of Patients’ Requests for Direct-to-Consumer Advertised Antidepressants
It strikes me as highly ironic that two very big markets for prescription drugs, and that feature lots of ads, are (1) drugs to help you fall asleep (Ambien, Ambien CR, Lunesta, Rozerem) and (2) drugs to help you stay awake (Provigil). It suggests that perhaps the problem is not a medical one, but a social one — we as a society just don’t get enough sleep. And no amount of pills will solve that. No matter what drug ads claim.
Or, as Lazarus put it:
I asked Antonacci what else could cause excessive sleepiness.
“The No. 1 cause of excessive sleepiness is not getting enough sleep,” she replied.
I’m no doctor, but the remedy for that seems simple enough.
Last month, the House Energy and Commerce Committee announced that it would be looking into the use of celebrities in drug advertisements, and in particular into the appearance of Doctor Jarvik in Pfizer’s ads for Lipitor. We posted “Should you trust Dr. Jarvik on Lipitor?” discussing this investigation. It was revealed back then that Dr. Jarvik has never had a license to practice medicine, is not a cardiologist and thus has never written a prescription.
The New York Times ran an article today, ““Drug Ads Raise Questions for Heart Pioneer” describing the dust-up, and providing some additional damning details that don’t exactly improve the credibility of Dr. Jarvik or Pfizer.
Here’s some of the juicier excerpts:
The ads depict Dr. Jarvik rowing on a lake. But…
And, for that matter, what qualifies him to pose as a rowing enthusiast? As it turns out, Dr. Jarvik, 61, does not actually practice the sport. The ad agency hired a stunt double for the sculling scenes.
“He’s about as much an outdoorsman as Woody Allen,” said a longtime collaborator, Dr. O. H. Frazier of the Texas Heart Institute. “He can’t row.”
Rep. John Dingell (D-MI), who is leading the investigation, said:
“It seems that Pfizer’s No. 1 priority is to sell lots of Lipitor, by whatever means necessary, including misleading the American people,” Mr. Dingell said.
Lipitor, the world’s single best-selling drug, is Pfizer’s biggest product, generating sales of $12.7 billion last year. But as it has come under competition from cheaper generic alternatives, Pfizer has used the Jarvik campaign, introduced in early 2006, to help protect its Lipitor franchise.
Pfizer spent $258 million from January 2006 to September 2007 advertising Lipitor, according to TNS Media Intelligence. Much of that went for the Jarvik campaign.
Spending $258 million to get $12.7 billion is a pretty good return on investment. Of course, that number doesn’t include the other promotional spending to drive up Lipitor prescriptions, such as the cost of pharmaceutical “salespeople” and free “samples.” Assume for the sake of argument that Pfizer spent as much on those types of promotion as they did on ads, for a total of a strictly-hypothetical $516 million. That’d be a return of 2,460%. Not bad at all. (Of course, not all of the spending on Lipitor in 2007 can be attributed to the marketing, but the returns are still pretty handsome.)
Moving on…
Despite the efforts by industry and government to curb drug advertising, spending on consumer drug ads increased more than 300 percent from 1997 to 2007, when it reached about $4.8 billion.
There are various estimates for how much in additional sales you get for each dollar you spend in consumer drug ads. They range from $1.50 to $4.20. Pretty good returns no matter how you slice it.
And back to the row about the rowing…
A newsletter published by the Lake Washington Rowing Club in Seattle describes how one of its rowers was a stunt double in the ad for Dr. Jarvik. The sculler, a professional photographer and rowing enthusiast named Dennis Williams, was picked partly for his size and partly because, like Dr. Jarvik, he has a receding hairline, according to the newsletter, which said a crew filmed the commercial for three days at Lake Crescent, near Port Angeles, Wash.
In the ad, Mr. Williams was shown as a solitary sculler navigating an unspoiled lake. Through deft editing, he appeared to be Dr. Jarvik. But, in fact, the frames that actually included Dr. Jarvik were shot in a rowing apparatus on a platform, according to the newsletter.
So Jarvik’s not a licensed MD, not a rower. Does he really even take Lipitor? Is that really his receding hairline, or it’s a hair-double’s? (Of course if you were going to have a “hair-double,” you’d go for the full head of flowing locks, right?)
In conclusion, we have the world’s best-selling drug owing a likely-good-sized-chunk of its success to the appearance of a man whose credibility, at this point, is highly questionable. I’d suggest that, rather than shying away from featuring “doctors” in drug ads who aren’t really doctors, perhaps drug companies should embrace it. In the style of “I’m not a doctor, but I play one on TV.”
Certainly, there are many actors and other non-medical celebrities who play doctors who probably have more credibility with many viewers than real doctors. I offer here a few suggestions:
Zach Braff, who plays Dr. John Dorian on the hit comedy “Scrubs.”
Katherine Heigl, who plays Dr. Izzy on Grey’s Anatomy. (But she also starred earlier in her career in “Side Effects,” an independent film poking fun at drug company salespeople, so perhaps not… Incidentally, I appear in Money Talks: Profits before Patient Safety, a documentary about the drug industry that Kathleen Slattery-Moshkau, the director of Side Effects did as a nonfiction counterpart to her comedy feature. So if we’re playing “Six Degrees of Katherine Heigl” that means there’s just two degrees between me and Dr. Izzy. We’re practically cousins. Katherine, how come you never call?)
Dr. Teeth, bandleader of the “Electric Mayhem,” a regular staple on the Muppets in the late 70s. With the kids who grew up with the Muppet Show rapidly approaching and entering their 40s, he might be perfect.
Dr. J, aka Julius Erving, legendary basketball player
Dr. Nick, intrepid medical provider to the denizens of The Simpsons, known for his distinct “Hi Everybody!” greeting, demonstrating his solid bedside manner and approachability.
Dr. John, famed New Orleans musician.
I could go on like this all day. Other suggestions of famous doctors, medical or otherwise, that Big Pharma should recruit for drug ads? Post a comment with them…
Pfizer’s commercials for Lipitor featuring Dr. Robert Jarvik, “inventor of the artificial heart,” are probably among the most recognized drug ads on TV today. The ads rely on us viewers assuming that because Dr. Jarvik supposedly invented the artificial heart, he must be an authority on cholesterol… Right? The ad above has Dr. Jarvik saying “Just because I’m a doctor doesn’t mean I don’t worry about my cholesterol.”
Hmmm… What if the ads also said that Dr. Jarvik never actually practiced medicine, and in fact never even got licensed to practice medicine? Suddenly, he doesn’t seem like that much of an authority, does he?
Well, apparently that is the case. The Energy and Commerce Committee of the US House of Representatives is investigating “the use of celebrity endorsements of prescription medications in direct-to-consumer advertising, specific to Dr. Robert Jarvik’s appearance in Pfizer’s Lipitor Commercials,” according to the Committee’s press release:
Washington, D.C. – Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, announced today that they are opening an investigation into the use of celebrity endorsements of prescription medications in direct-to-consumer advertising, specific to Dr. Robert Jarvik’s appearance in Pfizer’s Lipitor Commercials.
“We are concerned that consumers might be misled by Pfizer’s television ads for Lipitor starring Dr. Jarvik,” said Dingell. “In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine.”
“Dr. Jarvik’s appearance in the ads could influence consumers into taking the medical advice of someone who may not be licensed to practice medicine in the United States,” said Stupak. “Americans with heart disease should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break.”
It’s not surprising that Pfizer chose Dr. Jarvik as its spokesperson. In the past three years, we’ve seen a stampede of white coats in drug ads — either actual doctors or actors dressed up like doctors. The white coat conveys authority and gravity to the ads.
But there’s something very bothersome about using a “Doctor” who has no license to practice medicine, and who in fact apparently has never done so, to advertise Lipitor. And that is the fact that particularly when it comes to cholesterol medications, the prescribing details matter. The decision of whether to prescribe a statin (such as Lipitor, Crestor, Zocor, Pravachol, etc.) and which statin to prescribe are ones that require a fair amount of knowledge and experience on the part of the doctor — different patients need different statins, different statins have different side effects. So who should use Lipitor -versus another statin or even versus just changes to diet and exercise – are complicated questions requiring doctors to know a fair amount. Yet Pfizer has Dr. Jarvik, who can’t even practice medicine, advising consumers to take Lipitor!
It’s a measure of what Pfizer thinks of us lowly consumers that they use a celebrity doctor spokesperson who can’t even prescribe the product they’re endorsing.
What with the recent flap over Montel Williams, PhRMA’s patient assistance spokesperson, threatening to “blow up” a high school student, and now the revelation about “Doctor” Jarvik, it makes us wonder whether celebrities are the best choice for drug ads…
You could say that ads for prescription drugs were the camel’s nose under the tent. Once you start advertising prescription drugs like they’re shampoo or fabric softener, what’s next? How about medical devices? Or even surgical procedures? Heck, why NOT? If you’re going to turn medical treatments into a consumer commodity, why not go whole hog, as it were?
Well, because, of course, it’s a terrible idea. Medical treatments, be they pills, devices or procedures, are not consumer goods, and we shouldn’t treat them like consumer goods. It minimizes their importance, causes people to use them when they shouldn’t, and most fundamentally, promotes the notion that health care is a “product” that we “consume.” It is a triumph of marketing over medicine that we now consider ourselves health care “consumers” rather than “patients.”
Some might argue that this can be a good thing, given people’s interest in being informed, empowered consumers; that it’s a further shift from the old “doctor knows best” days when we were passive recipients of whatever our doctors deemed was in our interest. But medical marketing doesn’t necessarily turn us into empowered consumers — it just as easily turns us into the unpaid sales force for drug and device companies — and the target we’re trying to sell to, ironically, is ourselves, and our doctors.
Now a new frontier is opening in health-care advertising that may be even trickier to evaluate: ads for medical devices and procedures.
A raft of ads for everything from hip replacements to radioactive seeds to treat prostate cancer has hit the airwaves over the past couple of years, as companies tap the aging population to boost sales. And like most commercials, the ads don’t pull any punches. A spot that launched in January for Medtronic’s implantable defibrillator, used to revive someone who’s suffered cardiac arrest, promises a longer life for patients. “If you’ve had a heart attack or have heart failure, inside this little device, you just might find 10,000 more kisses, snow, 200 more football wins…
We here at PAL frequently argue that drug ads are on balance a bad thing, and in making this argument, we frequently pose the hypothetical of medical procedures being advertised. “Most people,” we like to say, “would think it a bad thing if they saw an ad for open heart surgery, or a coupon for 20% off your next colonoscopy.” Yet that’s exactly the type of promotion that the market is starting to move towards.
Here’s one example of a TV ad for a medical device:
Want to give the breast holiday present ever? How about the gift that keeps on giving: Plastic surgery!
We’ve all heard about high schoolers begging for — and getting — nose jobs for graduation or sugar daddies funding their girlfriends’ lunchtime lipo, but now, just in time for Christmas, you can give the one you love a BOTOX® Cosmetic (Botulinum Toxin Type A) gift card. Just wait until you see the (lack of) expression on her face when she unwraps what she thinks is a $50 Bed, Bath & Beyond gift certificate but is actually the pathway to three-to-six months of eternal youth.
“Dear Journalist,” the press release addressed to me read, “For your Holiday Gift Guide, please consider a story about taking the stress out of finding the perfect holiday gift! A recent international survey found that 52% of women ‘of a certain age’ would like to receive cosmetic injectables as a gift, which begs the question … how do you wrap it?”
One question about ads for medical procedures and devices is whether they contain adequate information about risks and side effects. Obviously, a medical device has one key difference from a drug: You can stop taking a drug at any time, but you can’t just yank out a knee replacement, gastric band or cardiac defibrillator. If you have a problem with a medical device, or if new information about risks comes to light, you usually have to have surgery to remove it — which can take time, be costly, and have its own risks. Consumer Union, the publisher of Consumer Reports, recently petitioned the FDA to require that all ads for implantable devices warn consumers about the risk of hospital-acquired infections and the expected life span of the advertised device. Here’s an excerpt of the press release:
Advertisements for Medical Devices, Implants Should Carry Warnings of Dangerous Side Effects, Infections
Consumers Union petitions FDA to require clearer warnings on DTC device ads
(Washington, DC) – Consumers Union has filed a petition with the FDA requesting it require all advertisements for implantable devices – such as knee, hip and heart valve replacements, cosmetic implants and heart stents – carry a warning about the possibility of dangerous infections or failures of the devices once they are in the body.
Implantable device makers recently have launched a wave of direct-to-consumer advertisements for their products, and Consumers Union said a review of these ads show that most lack basic information about the possibility of severe or fatal side effects.
“There is no question that many of these devices can restore high quality-of-life in patients, but we are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.
“We’re asking the FDA to require clear warnings about the dangers of infection during and following such surgery, and information about how long the devices are likely to last once they are in the body,” Vaughan said.
(The full Consumers Union FDA petition can be found here.)
All of this begs the larger question of whether advertising medical treatments — drugs, devices, procedures — at all is a good idea. Most countries don’t allow so-called “Direct-to-Consumer Advertising.” Yet the pharmaceutical industry alone spent more than $5 billion advertising prescription drugs in 2006, and that number has been growing steadily since 1997. The reason? It’s extremely profitable. Estimates vary, but on average every dollar spent on drug ads produces $1.50 to $4.20 in sales — quite a handsome return on investment. Other industries, particularly the medical device industry, are no doubt eager to hop on board this gravy train. But we rightly should ask whether it’s for our benefit… or their bottom line.
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