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.
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 brand-name pharmaceutical industry constantly pushes the myth that its expensive blockbusters are breakthrough treatments that greatly increase people’s health and well-being, and thus are worth the high price-tag. That myth has more holes than a slice of swiss cheese, yet they keep pushing it on the American public like it’s one of their drugs.
As Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of “The Truth About the Drug Companies” (see an interview with Dr. Angell in PAL’s newsletter here) famously said, “Important new drugs do not need much promotion. Me-too drugs do.” So drugs which offer little breakthrough in treatment need to be (over)hyped.
For years, the drug industry has touted antidepressants (particularly SSRIs - Selective Serontin Reuptake Inhibitors — Prozac, Paxil, Wellbutrin, Zoloft, Celexa, Lexapro, etc. as one of its major successes. Yet, this week, a major meta-analysis (a study that reviews the full range of studies and articles on a particular drug) was published in the open-access medical journal PLoS (Public Library of Science) Medicine. That article concluded that, for the majority of patients, SSRI antidepressants are barely better than a placebo.
It’s likely that patients in the U.S. (and their health plans, and government health care programs like Medicare, Medicaid, the Veterans Administration, the military health care plan Tri-Care, etc) have spent tens of billions of dollars on antidepressants in the past decade, despite the fact that for many of them, it was likely a waste of money, exposed them to the risk of side effects, and may have resulted in their not availing themselves of other non-pharmaceutical options for treating their depression.
Drugs for depression are just one of numerous groups of drugs for which the benefits are overhyped and people for whom an expensive drug is unnecessary or overkill are convinced to take it in lieu of something cheaper, that’s been around longer and whose risks and benefits are more well known.
“Statin” drugs for reducing high cholesterol are another group of drugs that have been massively overhyped, and that also have been in the news a great deal lately. Last month, the results of a study of Schering-Plough and Merck’s combination-cholesterol drug Vytorin, the ENHANCE study, were released, showing that it offered no benefit over simvastatin (Zocor), a statin that last year went generic. Vytorin is a combination of Zocor and Zetia, which is also sold by itself. Vytorin and Zetia together have more than $5 billion in sales.
Statin drugs have also been in the news because of the revelation that Dr. Robert Jarvik, Pfizer’s boat-rowing pitchman for Lipitor, is not a licensed physician, cannot write a prescription for Lipitor or any drug for that matter, and is not even a rower (a stunt double was used in the Lipitor ads). We’ve blogged about Jarvik-gate here on several occasions, including proposing some other famous “doctors” who aren’t licensed physicians that Pharma ought consider using as paid flaks — including Dr. Teeth from the Muppets, Basketball legend Dr. J, Dr. Nick Riviera from the Simpsons, and New Orleans musical legend Dr. John).
Of course, the real Lipitor story is not Dr. Robert Jarvik and his rowing and prescribing credentials. At best, he’s a bit player in this drama. The real story is how incredibly overhyped Lipitor is. Pfizer boasts it’s the “most powerful” statin as though that means that everyone with high cholesterol should be on it. But for many (perhaps most) people with high cholesterol, using Lipitor is like using a chainsaw to cut paper instead of scissors: that is, unnecessary overkill. Members of the PAL coalition filed a lawsuit against Pfizer in 2005, alleging that Lipitor had been overhyped and promoted to patients for whom it offered no benefit, and we gave them and AstraZeneca, the makers of Crestor, a Bitter Pill Award in 2006: The “Got Cholesterol?” Award: For Overpromoting Expensive Brand-Name Statins.
[Statins] are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006. Half of that went to Pfizer for its leading statin…
The second crucial point is hiding in plain sight in Pfizer’s own Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read the smaller type. It says: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”
Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100.
Compare that with, say, today’s standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1. Give the drugs to 11 people, and 10 will be cured.
A low NNT is the sort of effective response many patients expect from the drugs they take. When Wright and others explain to patients without prior heart disease that only 1 in 100 is likely to benefit from taking statins for years, most are astonished. Many, like Winn, choose to opt out…
NNTs are the “dirty little secret” of the world of prescription drugs. And a perfect illustration of how hyping drugs through advertising to consumers and marketing to doctors (through the 100,000 salespeople employed by drug companies, self-serving biased clinical trials and corporate-influenced “continuing medical education”) doesn’t benefit patients. As the article says,
The truth about drugs’ effectiveness wouldn’t be as worrisome if consumers and doctors had an accurate picture of the state of knowledge and could make rational decisions about treatments. Studies by Darlington Hospital’s Trewby, UBC’s Wright, and others, however, show that patients expect far more than what the drugs actually deliver…
The whole statin story is a classic case of good drugs pushed too far, argues Dr. Howard Brody, professor of family medicine at the University of Texas Medical Branch at Galveston. The drug business is, after all, a business. Companies are supposed to boost sales and returns to shareholders. The problem they face, though, is that many drugs are most effective in relatively small subgroups of sufferers. With statins, these are the patients who already have heart disease. But that’s not a blockbuster market. So companies have every incentive to market their drugs as being essential for wider groups of people, for whom the benefits are, by definition, smaller.
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.)
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…
The director of Prescription Access Litigation (PAL) appears in a documentary called “Money Talks: Profits Before Patient Safety”. The film focuses on the questionable marketing tactics of the pharmaceutical industry. A trailer is below:
It shares this honor with a number of other distinguished documenatries, including “Jesus Camp,” “Maxed Out,” and Spike Lee’s “When the Levees Broke.”
We here at PAL are honored to have been part of this project and applaud the filmmakers, Kathleen Slattery-Moschkau (director of “Side Effects,” an independent feature film on drug marketing starring Grey’s Anatomy’s Katherine Heigl) and Holly Mosher, of Be Well Media. To learn more, go to www.moneytalksthemovie.com. The filmmakers’ press release is below:
Madison, WI (PRWEB) January 24, 2008 — The American Library Association Video Round Table Committee has announced their top picks for the “2008 list of Notable Videos for Adults.” Among the committee’s 15 choices was the award-winning and timely documentary Money Talks: Profits Before Patient Safety by critically acclaimed filmmakers Kathleen Slattery-Moschkau and Holly Mosher. The film offers compelling insight into the questionable marketing tactics of the pharmaceutical industry.
“Money Talks presents a wealth of unsettling information and forward-looking ideas about one of the most urgent issues facing our country today. This film should be required viewing for anyone concerned about the complexities and failings of the American health care system,” said Meghann Matwichuk, University of Delaware, Media Librarian / Video Round Table Notable Videos for Adults Committee Member.
Each year the committee selects top educational and instructional titles based on criteria that include expanding the viewers’ knowledge, clarifying a difficult topic, and contributing to the solution.
The 50-minute documentary explores the pervasiveness of drug industry influence through featured interviews with medical community heavy-hitters, including Harvard’s Dr. John Abramson, author of Overdo$ed America; Columbia University’s Dr. Bob Goodman, founder of the ‘No Free Lunch’ program; Alex Sugerman-Brozan, director of Prescription Access Litigation; and Dr. Jerome Hoffman of UCLA Medical School.
Money Talks: Profits Before Patient Safety is Slattery-Moschkau’s and Mosher’s second film about the issues within the pharmaceutical industry. Their internationally acclaimed debut film Side Effects, starring Katherine Heigl, was a fictional look at writer/director Slattery-Moschkau’s decade working as a sales rep for two of the nation’s top drug companies.
Most recently, the two outspoken consumer health advocates launched Be Well Media, a nonprofit media production and promotion company focused on healthcare education via entertainment.
Money Talks: Profits Before Patient Safety is available on DVD, or as part of an educational viewing package at www.moneytalksthemovie.com.
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.
Critics of drug ads have been calling for restrictions ever since the ads hit the airwaves back in 1997. The pharmaceutical industry has always been able to block any Congressional attempts at putting meaningful regulation into place. This past year, a number of Congressional Reps and Senators tried to put in place a “moratorium” in which new drugs would not be able to advertise to consumers for a certain length of time (say, two years). Even that modest reform was removed from the final bill, which became the FDA Amendments Act of 2007. (FDAAA, which we prefer to pronounce as though it’s “open wide and say FDAaaaaaa….”).
One reform did make into the final legislation, however. But don’t fret — the ad agencies that produce drug ads won’t be showing up on your street corner with “Will Shill for Food” signs anytime soon. The FDA has never had the power to require drug companies to submit their ads before they hit the airwaves, and they still don’t. But, now, drug companies can voluntarily submit drug ads to the FDA for “pre-broadcast review.” If they choose to do so, they have to pay a fee for that review. And the FDA has just announced that the fee for each ad in 2008 will be $41,390. That’s a pretty modest fee – most ads no doubt cost much more than that to produce and to air.
How did the FDA arrive at this seemingly odd number? Why $41,390 and not $57,642? The FDAAA called for the FDA to raise $6.5 million for the program in the first year. The FDA asked drug companies to estimate how many ads they’d submit in 2008, and then divided $6.5 million by that number. Which means that drug companies estimated that they’d be submitting 157.04 ads for pre-broadcast review in 2008 (I, for one, look forward to seeing the .04 ad – I imagine it won’t get past “Ask you doctor ab…”).
What if a drug company goes over its estimate? It pays a 50% surcharge.
Now one might reasonably ask “Why would a company submit an ad for pre-broadcast review if it’s voluntary?” And that’s a good question. Arguably, many won’t. Those that will are hoping to avoid the FDA later issuing an enforcement letter citing violations in their ads. Better to get “clearance,” if you will, beforehand, than a rebuke after the fact. This is the reverse of the old saw that it’s better to seek forgiveness than permission.
Here’s what’s unclear: What legal status will an FDA pre-broadcast approval of an ad have?
What if, for instance, consumers are deceived by an ad that overstates a drug’s effectiveness or understates its risks, despite the FDA’s pre-broadcast review, and file a lawsuit claiming that the ad violates state consumer protection acts? I have no doubt that drug companies will argue that an FDA pre-broadcast approval of an ad “preempts” any claims under state law that an ad was unfair or deceptive. The industry has been arguing that virtually any claim under state law that a person was harmed, deceived, injured or even killed is “preempted” by the FDA’s authority to regulate prescription drugs. (We’ve written about the preemption issue ad nauseam on this blog — see archived posts on the topic here).
Arguably, the standards that the FDA will apply in its pre-broadcast review are different than those that are relevant to state consumer protection laws, which aim to protect the public from “unfair or deceptive” conduct in the marketplace. The FDA is primarily concerned with making sure that drug ads do not “misbrand” drugs a term from the Food, Drug and Cosmetics Act and the FDA’s regulations.) Conduct that is “unfair or deceptive” under state law is arguably broader than conduct that constitutes “misbranding.” But conduct that constitutes “misbranding” is most likely also “unfair or deceptive” under these state laws. This is a good example of how state consumer protection law and the FDA’s authority are complementary, rather than contradictory. So I would argue that an FDA pre-broadcast approval should not insulate a drug company from liability under state law. Whether or not courts will agree is an open question — the jury, as they say, is still out on the issue. The Supreme Court just recently took up the preemption issue generally in the case of Riegel v. Medtronic, a case that concerned medical devices, not drugs. (PAL joined an amicus brief in that case, and we’ve blogged on it here before.) The Supreme Court’s ruling on preemption in that case is likely to have some effect on how Courts address drug preemption issues, although not as much as if the Supreme Court directly addressed the question of preemption in the realm of drugs.
It will be interesting to see how the FDA pre-broadcast review program shakes out in its first year. Will it result in fewer enforcement letters being issued? Will it change the tone and tenor of drug ads in any meaningful way? To find out, all you’ll need to do is stay tuned to your TV, where drug ads will continue to bombard you on a regular basis. Enjoy!
Here’s Consumer Report’s very clever and thorough deconstruction of the ad:
John Mack reports on the Pharmaceutical Marketing Blog that this critique angered folks at the Restless Legs Syndrome Foundation. Guess who’s a major sponsor of this alleged consumer group? Why, GlaxoSmithKline, of course, the maker of Requip! Here’s what John Mack wrote about this today:
However, CR does have a HUGE readership that I can only dream of! As a result, its attack on Requip drew the attention of the Restless Leg Syndrome Foundation, the supposedly grassroots patient advocacy group with suspicious monetary and corporate ties to GlaxoSmithKline (GSK), the marketer of Requip (see posts cited above).
The RLS Foundation issued this clarion call to its “members”:
“We wanted to apprise everyone on our mailing list of some bad press for RLS. We want to encourage you to ‘fight back’.
“A video on consumerreports.org promises ‘relief from restless legs hype.’ The RLS Foundation is taking a tough stand against this type of bad press for RLS.
“Click here to watch this extremely sarcastic and insulting video for yourself. Then, click here to read the RLS Foundation’s response to this video.
“The RLS Foundation is calling for drastic measures to respond to this video. We aren’t concerned that they are reporting on a drug. We are concerned that they are mocking a condition that so many people live with everyday. We encourage you to respond to this advertisement immediately. If you are a subscriber of Consumer Reports, we encourage you to cancel your subscription….”
We applaud Consumer Reports for its new AdWatch feature and for examining the Requip ad. While RLS is a real condition and some people will get relief from drugs such as Requip, the shameless overmarketing of it through ads like this is enormously harmful. The purpose of drug ads is to expand the market for the advertised drug, to convince as many people as possible that they need a particular drug, even if they don’t actually need it. Since 2005, we have been calling attention to and critiquing particularly troublesome drug ads through our Bitter Pill Awards: Exposing Drug Company Manipulation of Consumers. We’re glad to be in the company of Consumer Reports in our efforts.