Latest Drugwonks' Blog
Pfizer Drops Celebrity Pitch in New Lipitor Spots
As Generics Catch Up, Dr. Jarvik Is Jettisoned
From Heart-Drug Ads
By JON KAMP
The new television ad, set to debut Tuesday, features a testimonial from heart-attack survivor John Erlendson, a 58-year-old
In other words, they should talk to their doctors about Lipitor. The new campaign comes amid pressure on Pfizer's marquee drug from generic competition, and it follows criticism that prior Lipitor commercials featuring Dr. Jarvik were misleading. The New York-based company pulled the Jarvik ads in February amid criticism, and attention from a U.S. House committee, linked to the fact he isn't a practicing physician.
This time around, Pfizer felt that using an average guy, someone with a story similar to that of many other baby boomers, struck the right chord.
"When we did testing with consumers, what we found out was John really resonated with them," said Jim Sage, senior director and leader of the Lipitor marketing team at Pfizer.
Mr. Sage declined to say how much the drug company is spending on the new campaign but said it will have a wide presence on TV and in print. "This ad is going to run for a while on a national basis," he said.
Lipitor, the world's best-selling prescription drug, is a so-called statin drug that is typically taken once daily to block an enzyme in the liver that helps make cholesterol. The U.S. Food and Drug Administration approved Lipitor 12 years ago.
The drug had sales of $12.7 billion in 2007, a 2% decline from the prior year. Sales through the first half of 2008 were up 1%, with a strong overseas showing bolstered by the weak dollar.
Lipitor is feeling heat from health plans promoting the use of cheaper, generic versions of other cholesterol drugs. It stands to lose protection against generic copies in the
The new spot is visually similar to some of the Jarvik ads, in that it shows Mr. Erlendson in an outdoorsy setting, biking and picnicking by the water with his wife and son -- a notable ad with Mr. Jarvik showed a body double rowing a racing scull across a lake. But the new ad takes a different approach, relying on its star's experience rather than expertise, and his appeal for viewers to avoid his missteps.
"Talk about a wake-up call. I had a heart attack at 57," Mr. Erlendson says in the commercial's opening, in which he's filmed in close-up and black-and-white. "My doctor told me I should have been doing more for my high cholesterol. What was I thinking? But now I trust my heart to Lipitor." He had tried to tamp down his cholesterol with diet and exercise.
The commercial shifts to the color outdoor scenes -- while the drug's benefits and potential side effects are reviewed by a voice-over -- and closes with advice for viewers to discuss their risk and Pfizer's drug with their doctors.
The phrase "a Lipitor heart to heart" appears on screen near the beginning and end and will be a recurring theme in other ads.
While marking a departure from the Jarvik ads, which leaned on a figure with stature in matters of the heart, Lipitor's new pitch man is not a total outsider. The talent agent -- who will be paid a union scale rate -- said he learned of the ad campaign when news of Pfizer's search for a testimonial subject crossed his desk. They were looking for a heart-attack survivor who took Lipitor, and he knew one who fit the profile.
"I'm hoping my message can get out to people like myself," Mr. Erlendson said.
Future ads could follow the theme of the new spot and may feature other Lipitor users; Mr. Erlendson could also reprise his role.
http://michellemalkin.com/2008/08/31/palin-derangement-syndrome/
The authors used a general practice research database which "contains information from over six million patients registered at over 400 general practice surgeries in the UK.11 Continuous information is recorded for each patient, including a record of each consultation, any diagnoses made, all prescribed medicine, and basic demographic data. The geographical distribution and size of general practices represented in the database are largely representative of the population of England and Wales, and the individuals registered on the database are representative of the whole UK population in terms of age and sex.12 The data held are rigorously checked and regularly audited and have been successfully used to conduct over 500 peer reviewed published studies. The information obtained from the database is entirely anonymous."
The authors were able to control for length of drug use, type of drug, and "measured the differential effects of typical and atypical antipsychotics among all patients and stratified by dementia status."
The most relevant results are here:
| Any antipsychotic drug | Typical only | Atypical only |
| Patients with recorded dementia (n=1423) | |||
| No in group | 1423 | 1208 | 85 |
| Exposed v unexposed periods | 3.50 (2.97 to 4.12) | 3.26 (2.73 to 3.89) | 5.86 (3.01 to 11.38) |
| Days after treatment: | |||
| 1-35 | 4.03 (3.34 to 4.87) | 3.74 (3.05 to 4.59) | 5.70 (2.50 to 12.98) |
| 36-70 | 3.04 (2.33 to 3.96) | 2.92 (2.20 to 3.88) | 4.41 (1.40 to 13.89) |
| 71-105 | 2.71 (1.97 to 3.73) | 2.40 (1.69 to 3.41) | 3.50 (0.76 to 16.25) |
| 106-140 | 2.14 (1.45 to 3.15) | 2.16 (1.44 to 3.23) | 2.21 (0.28 to 17.34) |
| 141-175 | 1.53 (0.95 to 2.44) | 1.49 (0.90 to 2.44) | 2.40 (0.30 to 18.88) |
The authors note that only a handful of patients even received an atypical so it is hard to extrapolate beyond what previous studies have suggested: that people 80 and older are much more likely to have a stroke than other groups of patients and that a small statistical association between stroke and atypicals exists. However, it is unclear from the data whether the association is a function of dose or duration. In any event, the research provides a much needed systematic assessment of an important clinical issue dealing with the treatment of dementia.
Not so the rigged and biased attack Curt Furberg launches on all oral diabetic drugs....
"We reported [in the journal Diabetes Care] in June 2007 that thiazolidinediones doubled the risk of congestive heart failure in patients with type 2 diabetes...The increased heart failure appears to be a class effect."
Well, appearances are deceiving, especially when you are reporting on a highly selective group of studies....
A random-effects meta-analysis of three randomized controlled trials showed an odds ratio (OR) of 2.1 (95% CI 1.08-4.08; P = 0.03) for the risk of heart failure in patients randomized to TZDs compared with placebo. Four observational studies revealed an OR of 1.55 (1.33-1.80; P < 0.00001) for heart failure with TZDs. A dose-time-susceptibility analysis of 28 published reports and 214 spontaneous reports from the CADRMP database showed that heart failure was more likely to occur after several months (with median treatment duration of 24 weeks after initiation of therapy). Heart failure equally occurred at high and low doses. The adverse reaction was not limited to the elderly, with 42 of 162 (26%) of the reported cases occurring in patients aged <60 years. CONCLUSIONS: Our teleo-analysis confirms the increased magnitude of the risk of heart failure with TZDs. We estimate the number needed to harm with TZDs to be approximately 50 over 2.2 years. Existing guidelines and package inserts may have to be revised to incorporate these risk characteristics of TZDs..
Furberg also uses the ACCORD and ADVANCE studies to justify yanking Avandia off the market. According to ScienceDaily, here is Furberg's logic:
"They said that results from three large randomized clinical trials published this past June all failed to demonstrate that intensive control of blood sugar reduces mortality or events from cardiovascular disease in patients with type 2 diabetes.
The three trials were ACCORD, ADVANCE, and the Veterans Affairs Diabetes study. In ACCORD, the patients who received intensive treatment to control blood sugar actually had more cardiovascular disease mortality than patients receiving standard treatment."
Uh, maybe because they were sicker to begin with.
In any event, what has that to do with Avandia's risks and benefits. Nothing. But Furberg is grasping at straws here and he knows it.
Yes, post market evaluation of meds is important. But it needs to be done right and honestly.
Even the NY Times know when they are being jerked around.
First of all, the article points out, the $2,500 figure includes not only the portion of premiums paid by individuals, but also the large portion paid by employers and, in the case of Medicare and Medicaid, the government.
Given that caveat, what’s the source of the $2,500 figure? It comes from this memo, put out by three Harvard professors who are unpaid advisers to the Obama campaign. They cited RAND findings that investing in health IT could $77 billion a year, and improving management of chronic disease could save another $81 billion. Cutting administrative costs in the insurance industry could save up to $46 billion, the memo said, citing the Commonwealth Fund.
The memo points out that it’s impossible to predict actual savings, and cites a wide range of possible outcomes. But the authors say their best guess is annual savings of $200 billion.
They took that figure, divided it by the population of the U.S., multiplied to get a family of four, then rounded down to $2,500 to get a round number, the article says.
Whether all those savings estimates are realistic — and what time frame it would take to realize the savings — are both subjects of debate. Earlier this year, the Congressional Budget Office said stirred things up when it said that RAND may have overstated potential savings from investing in health IT.
And what about giving everyone else the same health care coverage members of Congress have? The plan would be paid for by cutting payments to doctors and hospitals. Obama's model for the national plan is not what his colleagues in Congress have but how states have tried to expand Medicaid to create universal health coverage.
Obama's National Health Exchange would set up a public planrequire all private insurers to accept everyone regardless of illness, pre-existing condition, etc. set premiums and then " require that all the plans offered are at least as generous as the new public plan and have the same standards for quality and efficiency. And that means price controls.
Obama claims this will eliminate bankrupcty from health care expenses and reduce uncompensated care expenses.
Not so. Rationing will force patients to sell off houses and pay out of pocket for services biggovhealth says no to. Just like in Canada and England. Allowing states to extend coverage to illegal immigrants and a new provision to provide health insurance to the children of illegal immigrants via SCHIP and Medicaid will see costs skyrocket and private hospitals will be forced to make up the difference between the federal reimbursement and what they have to spend on care, just as they do now.
Finally, "Obama will require that providers that participate in the new public plan, Medicare or the Federal Employee Health Benefits Program (FEHBP) utilize proven disease management programs. This will improve quality of care, give doctors better information and lower costs."
Is there any evidence of that? No. But we will have a government agency that will tell doctors what they can and cannot use based on one-size fits all and outdated studies of how to treat chronic illness. Such studies, because they ignore genetic, gender, racial differences will deepen health disparities. Combined with cuts in payments to doctors, care and coverage in the poorest areas will dry up.
Change. Yes we can.
But here’s how Alicia Mundy, in today’s Wall Street Journal, begins her story about a disease awareness campaign on just this public health issue:
“Pfizer Inc. has found a way to encourage the use of its antismoking drug Chantix without detailing serious potential side effects through a commercial that doesn't mention Chantix at all.”
Okay class, is this going to be a story that praises Pfizer (the world’s largest pharmaceutical company) for educating people about how to quit smoking? Or is it a story about how Big Pharma is trying to hide the fact that (gasp!) drugs have risks?
Ms. Mundy continues:
“Under Food and Drug Administration rules, if an ad doesn't directly name the drug, it doesn't have to include the reading of possible side effects that can chew up expensive television time.”
True. But consider the phrasing. For Ms. Mundy, “disease awareness” is just another clever ploy to avoid fair balance/adequate provision.
And she lumps all disease awareness ads together:
“This unbranded approach has been used in the past to promote disease awareness and build markets for treatments for those disease. Bob Ehrlich of DTC Perspectives, which monitors direct to consumer advertising by drug makers, says the Ambien and Chantix promotions may be clever, but ‘There's a risk they could rouse congressional ire over cute commercials that don't emphasize medicine.’ “
Bob, there’s a difference between these two campaigns. Check them out and judge for yourself. One has to assume that Ms. Mundy did – and that she’s decided that all disease awareness ads are the same – meaning that they are equally devious.
But, in fairness, she gives Pfizer the chance to comment:
“Pfizer says it isn't pushing Chantix in its ads, or trying to circumvent FDA rules. "The goal of the My Time to Quit campaign is to encourage people to quit smoking," said company spokeswoman Sally Beatty. "My Time to Quit is designed to encourage people who are thinking about quitting to speak to their healthcare provider about the benefits of quitting smoking and available treatment options," she said.”
Isn't it refreshing when Big Pharma stands up for itself?
Perhaps the most astounding and important paragraph in the article is the following:
"With unbranded ads, you don't have the 'fair balance' requirement," said Rich Gagnon of the ad agency DraftFCB, part of Interpublic Group of Companies Inc., in New York. "Imagine paying millions to run that ad campaign, and having to use up 30 seconds to list all the problems," said Mr. Gagnon, who has several pharmaceutical clients.”
“Imagine” paying millions to talk about risk? I should say its money well spent. Does Mr. Gagnon really believe that disease awareness ads are just a slick way to sidestep providing fair balance? If he was misquoted or if his comment was taken out of context, he should strive to correct the record a pleine vitesse.
Ms. Mundy also goes to Ruth Day – with whom we often disagree on DTC issues:
“Ruth Day of Duke University, a frequent critic of direct to consumer ads, gave the commercial and website high marks for useful information. An expert in how medical ads work on consumers, Dr. Day said mytimetoquit.com is relatively easy and gets to lists of side effects quickly.”
And we’ll leave it at that.
Do “complete response” letters offer more clarity or ambiguity? It depends who you ask.
Always included in that much touted number are scores of healthy young people — close to 20 million, by some accounts — who elect not to buy health insurance even though they can afford it. They voluntarily choose not to have health insurance — which is quite different from not being able to get health insurance.
Invulnerable? Not always.
Check out the new website, "don't be bob," that is trying to attract this segment of the uninsured population. It's good for these uninsured adults. It's good for the overall risk pool.
And it's a good start towards solving the problem with smart and savvy free-market solutions.
For more on that same sane notion of free-market solutions, have a look at the op-ed in today's Wall Street Journal by Grace-Marie Turner, president of the Galen Institute. She writes:
"A new study by University of Minnesota economists Stephen Parente and Roer Feldman shows that Congress could boost by more than 12 million the number of people who have health insurance without spending taxpayer dollars. The change required is to allow people to buy health insurance across state lines, so they can shop for less expensive policies ... For example, a typical health-insurance policy in heavily regulated New York costs more than three times as much as in less regulated Iowa ($388 a month versus $98 a month for the same coverage)."
But you won't hear any of that free-market hooey coming out of Denver.
Which means that Dr. Pasteur would have been been banned from doing such research and promoting it's value by Stanford. Instead, the funding would have gone to the dean of the medical school and a group of bureaucrats more interested in political correctness than medical progress. According to the new Stanford medical school policy on industry support for medical education, "the faculty, in conjunction with the office of CME, will decide the choice of topic and content for all Stanford CME activities, and curricula will be chosen based on the educational needs of our learner populations."
http://deansnewsletter.stanford.edu/#1
And as we all know, academics are free of any bias and never seek to steer money away from approaches they don't believe in and funnel cash to their own pet theories.
Which means that Pasteur, whose original ideas were rejected and ridiculed would have been labeled as "corrupted" by industry funding and would never have seen the light of day. CME would have gone instead to supporting treatments of disease based on spontaneous generation. Pasteur's subsequent work on the anthrax and rabies vaccine would be similarily attacked for it too had industry funding.
Pasteur challenged the dogma of the time and challenged his critics to attack him not in terms of circular and self-justifying arguments but by engaging in their own experimental research.
Attack my experiments," he challenged his critics. "Prove that they are incorrect instead of trying new ones that are merely variants of mine, but into which you introduce errors that then have to be pointed out to you."
Sadly today, that spirit is being extinguished by the new religion of politically correct science. When the Dean of one of the finest medical schools in the country claims "the historical and traditional models of CME, based largely on lectures and discussion groups, have served a purpose, although their impact on truly enhancing medical knowledge that leads to improvements in health care outcomes is unresolved" he is parroting the catechisms of a anti-science caste who believe, without evidence, that commercial support of research, training and symposium have an adverse impact on public health.
Simply handing the CME cash over to medical schools is problematic particularly if the role of CME in health improvement is unresolved. And if Dean Pizzo and others truly believe that, then they should be not responsible for the nearly $1 billion in industry support for such activities. For all the prattle about lack of accountability in CME, their is no murkier moral or intellectual stew than an academic department at a major university or no entity better at siphoning dollars for overhead, salaries and indirect expenses.
The larger issue, that men and women of insight and teaching talent might find themselves barred by universities of promoting ideas and interests they have researched remains. So does the fact that medical schools have largely failed to serve the primary care and nonphysician workers who treat the medically underserved, those health care providers who don't have the money or the luxury of an tony academic appointment or CME cash.
As with all myopic ideological movements, the attack on industry support of CME has casualties. Public health will be one. Truth another. As Pasteur put it, "In each of us there are two men, the scientist and the man of faith or doubt. The two domains are distinct, and woe unto him who seeks to make the one encroach upon the other in the current imperfect state of our knowledge."
http://www.people.fas.harvard.edu/~agoldham/articles/pasteur.htm
Here's a new article from today's edition of The Scotsman:
Advertising rules stifle free market for prescriptions
By Peter Pitts
IN EUROPE, it is illegal for drug companies to advertise prescription-only drugs to consumers. But the European Commission (EC) recently announced that it will allow pharmaceutical firms to disseminate "information" on their products over the airwaves, on the internet, and in print.
I think this change can't come soon enough. For too long, European bureaucrats have put cost considerations before patient care, keeping patients in the dark about alternatives that may best address their needs. Officials have, I think, paid lip service to the idea of empowering patients with more information on treatment options.
James Copping, a principal administrator of the EC, said in 2006: "We want a system where patients can be empowered to take an equal part in healthcare decisions." But thus far, no such thing has happened.
Consider the European agencies tasked with weighing the effectiveness of various treatments, such as the UK's National Institute for Clinical Excellence (Nice) or Germany's IQWiG. These agencies exist to provide unbiased medical information to government.
But because they are operated by government, I would say they have a vested interest in keeping costs down and have an incentive to conclude that newer, more expensive medicines are no more effective than older, cheaper ones.
Nice offers an instructive example. In 2001, contrary to expert findings by licensing authorities in 65 countries – including Scotland – it cited "insufficient evidence" for recommending the use of Gleevec in leukaemia patients.
In 2002, US authorities approved Gleevec for the treatment of stomach cancer and it was deemed a miracle drug. It wasn't until 21 months later that Nice authorised the use of Gleevec for English victims of the disease.
IQWiG seems similarly set on depriving German patients of vital treatments. The agency has promoted an "efficiency frontier" as its governing methodology for evaluating treatments. But such jargon is smoke and mirrors, designed to cover for the government's preference for established – and generally less expensive – treatments, and by decreeing the most cost-effective option in a treatment category, these agencies effectively determine what a doctor must prescribe, irrespective of a patient's individual characteristics.
Obviously, pharmaceutical companies have products to sell. But, by allowing them to provide Europeans with medical information, they could serve as a counterbalance to the heavy-handed pronunciations of state-run comparative-effectiveness agencies.
Indeed, a great deal of evidence demonstrates that consumers benefit when drug manufacturers participate in healthcare decision-making.
In the US, for example, a 2002 study by the Food and Drug Administration found that direct-to-consumer advertising of pharmaceuticals improved both patient-doctor discussions and compliance with physician recommendations. The study also found that 88 per cent of patients who asked about a specific drug were afflicted with the condition in question.
A 2003 study in US health policy journal Health Affairs arrived at a similar conclusion. According to the study, ad- inspired doctor visits resulted in the advertised medicine being prescribed in only about 47 per cent of cases. Put another way, patients didn't get a prescription for the medicine they came in to discuss on more than half their visits. Even with advertising, doctors exert appropriate judgment when they prescribe drugs.
On other occasions, according to the study, previously undiagnosed medical conditions get treated – a good thing.
For European bureaucrats, there is reason for concern. If consumers can get additional information on drug options thanks to direct-to-consumer efforts, there's a good chance they'll start to ask the state-run health systems why they can't access certain treatments.
As European Parliament member Jorgo Chatzimarkakis recently argued: "Citizens cannot be deprived of information by their own governments on such crucial issues as one's health."
Government-run systems have demonstrated that they're not interested in spending more money, but armed with new information, consumers may be able to make the case to their leaders that the status quo of rationed, controlled care will no longer suffice.
The researches argue that neither health care spending or private premiums would go up that much because "hospital spending on uncompensated care has been relative stable. That is partly because the public hospitals and clinics that most often care for the uninsured often don't have many privately insured patients to absorb the costs."
Translation: most uncompensated care is due to the fact that Medicare and Medicaid don't pay the full cost of medical expenditures. Uncompensated spending has been stable because Medicare and Medicaid have held reimbursement rates steady and because in many cases the state match (to pay for the care of illegals) has skyrocketed with most of the money going to urgent care and maternal health, not complex medical procedures.
GIve people a full blue plate entitlement and watch both government expenditures rise and uncompensated care increase as well. In every state where a single payer plan has been enacted uncompensated care continues to go up. The best example is the Oregon Health plan which ensures the uninsured by rationing access to cutting edge treatments and raising taxes. The trend of uncompensated care since 1994 in that state is below.
Statewide Uncompensated Care by Year: | |||||||
Year | Charity Care | % Change from Prev. Year | Bad Debt | % Change from Prev. Year | Total Uncomp. Care | % Change from Prev. Year | |
1994 | 74,653,735 |
| 90,272,616 |
| 164,926,351 |
| |
1995 | 55,645,120 | -25.5% | 90,262,052 | 0.0% | 145,907,172 | -11.5% | |
1996 | 53,036,784 | -4.7% | 80,387,137 | -10.9% | 133,423,921 | -8.6% | |
1997 | 55,123,781 | 3.9% | 83,974,361 | 4.5% | 139,098,142 | 4.3% | |
1998 | 58,291,332 | 5.7% | 96,289,876 | 14.7% | 154,581,208 | 11.1% | |
1999 | 53,994,527 | -7.4% | 102,732,393 | 6.7% | 156,726,920 | 1.4% | |
2000 | 64,916,584 | 20.2% | 128,914,104 | 25.5% | 193,830,688 | 23.7% | |
2001 | 77,772,655 | 19.8% | 138,822,832 | 7.7% | 216,595,487 | 11.7% | |
| 2002 | 107,854,204 | 38.7% | 164,629,911 | 18.6% | 272,484,115 | 25.8% |
2003 | 183,626,444 | 70.3% | 221,580,947 | 34.6% | 405,207,391 | 48.7% | |
2004 | 268,333,010 | 46.1% | 269,741,864 | 21.7% | 538,074,874 | 32.8% | |
2005 | 374,330,244 | 39.5% | 301,574,208 | 11.8% | 675,904,452 | 25.6% | |
2006 | 445,884,426 | 19.1% | 305,343,908 | 1.3% | 751,228,334 | 11.1% | |
2007 | 524,707,945 | 17.7% | 351,866,447 | 15.2% | 876,574,392 | 16.7% | |
 | |||||||
The same thing happened in Tennessee when Tenncare was enacted. The idea that a single payer system will eliminate uncompensated care is bogus unless the single payer doubles what it pays providers, hospitals, etc. Just the opposite takes place in a single payer system. What will reduce uncompensated care -- apart from rationing which will drive up costs elsewhere -- are changes to the financial and technological structure of healthcare that reward saving and investment in personal health and staying healthy. Indeed, as the percent of people in consumer directed plans increases and includes the uninsured, the amount of out of pocket spending has remained stable and as a RAND study last year shows, the consumer directed plans are associated with reduced hospital and physician visits and increased access to prescriptions. This does not always "control" costs but does appear to improve quality by encouraging more management of costly chronic illnesses,
http://content.healthaffairs.org/cgi/content/full/hlthaff.27.5.w399/DC1
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
