Hospitalizations are reduced by the upfront use of a genetic test for "warfarin sensitivity," according to new results from a comparative-effectiveness study. The Medco- and Mayo-sponsored trial of the anticoagulant (the dosing of which has caused more than one headache in physicians and patients during the last 70 years) compared hospitalization rates among warfarin-treated subjects who underwent genetic testing and those who didn't. The trial results were presented this morning at the ongoing meeting of the American College of Cardiology in Atlanta; data are also available at the company's web site.
In the study, the dose of newly initiated warfarin therapy in nearly 900 adult patients* was adjusted on the basis of Medco's genetic test (performed on blood or cheek swabs). During a 6-month period, the hospitalization rate in this group was 31% lower than that of a historical control group (N = 2688) who had not undergone genetic testing (ITT analysis: ~18% vs ~25%). The hospitalization rate for bleeding or thromboembolism was 28% lower in the genotyped group.
Results from the per-protocol analysis were even more impressive. The rate of all-cause hospitalization and the rate of hospitalization for bleeding or thromboembolism were 33% and 43% lower, respectively, in the genotyped group.
The genetic test, which is available from several companies,** assesses the function of 2 genes, CYP2DC and VKORC1. The former encodes a well-known P450 enzyme that metabolizes warfarin; the latter encodes an enzyme that activates vitamin K (which counteracts the anticoagulant properties of warfarin). The cost of a warfarin sensitivity test is quoted in the press at a range of $250-$400. The FDA first approved use of the genetic test (Verigene; Nanosphere) to inform warfarin dosing in 2007.
According to Medco, about 30 million warfarin prescriptions are written and 2 million patients start warfarin treatment each year. Warfarin is the leading cause of ED visits, hospitalizations, and drug-related deaths. One third of the variability in response to the drug is ascribed to the genetically determined function of CYP2C9 and VKORC1.
Last week, the FDA added a boxed warning to the PI for the antiplatelet drug clopidogrel (Plavix; BMS/sanofi), which may be less effective in patients with reduced function of the CYP2C19 enzyme. (To become active, clopidogrel, a prodrug, must be converted by CYP2C19.) The FDA advised that 2%-14% of Americans are "poor metabolizers" of clopidogrel. CYP2C19 testing is also commercially available through a number of companies.
ITT = intent to treat; PI = package insert.
* Patients were recruited through 29 Medco-managed prescription benefit plans.
** For example, Ambry Diagnostics and Arup Laboratories.
Image of warfarin (Coumadin) bottles from NIGMS/NIH.
As just about everyone knows by now, the Special Masters of the US Court of Federal Claims handed down their decisions on Friday, which deny a causative link between the vaccine preservative thimerosal and autism in 3 test cases.
Among the many opinions rendered in the decisions from the Special Masters (see here, here, and here) are discussions of the autism studies published by Mark and David Geier—whose work has been criticized sharply and at length at this blog and in my 2009 letter to the Journal of the Neurological Sciences.
The court's Special Master George Hastings, for instance, writes in his decision re King v Secretary of Health and Human Services:
[M]ost of the epidemiologic studies that have addressed the thimerosal/autism causation issue have failed to find any association between thimerosal-containing vaccines and autism, but there have been certain exceptions. Those exceptions were studies published by the research team of Dr. Mark Geier and his son David Geier[*]...To be sure, the petitioners in this case have not cited or relied upon those Geier studies in their post-hearing briefs, because, as I will discuss below...the petitioners argue that all of the epidemiologic studies done to date are irrelevant to the petitioners' causation theory in this case. However, since I find that the epidemiologic studies are of relevance, I have found it reasonable to examine those Geier studies, to see if they afford any significant counterweight to the many contrary studies...
After careful consideration, I conclude that the Geiers' studies cannot be given any weight. A number of those studies were considered by the Institute of Medicine (IOM) committee that fully studied the entire thimerosal/autism causation issue in 2004. That committee concluded that the studies were so flawed as to be "uninterpretable," and that the studies contributed nothing meaningful ("noncontributory") concerning the causation issue...The committee noted that the studies were based on databases that themselves had "significant limitations"...and that the studies had "serious methodological problems"...or "serious methodological limitations"...The committee added that the Geiers' articles describing their analytical methods were "not transparent" and omitted "important details," so that it was impossible to evaluate the studies...Other specific deficiencies in the studies were also discussed, including the fact that the Geiers incorrectly used several epidemiologic terms and measures.
In addition, Dr. Fombonne [respondent's expert] agreed with the IOM's criticisms of the Geier studies, and testified that the Geier studies in general failed to use accepted epidemiologic methods...Dr. Rutter [respondent's expert] was critical of the Geier studies as well...Further, petitioners' own expert witness concerning epidemiology, Dr. Greenland, agreed with the criticisms of the Geier articles, acknowledging that those studies are "deficient in methodology"...And none of the expert witnesses for the petitioners vouched for the reliability of the Geier studies.
I have reviewed the published Geier studies discussed in the 2004 IOM report, and I agree with the analysis of those studies set forth in that IOM report. Further, I have reviewed the additional studies published by the Geiers since the 2004 IOM report, and find that those studies suffer from the same type of flaws as the earlier Geier studies. That view includes a study published in 2008 by the Geiers, along with Young as the third author. Two of respondent's experts, Drs. Fombonne and Rutter, testified that that 2008 study was again deeply flawed, and those experts provided a number of specific examples of deficiencies in the study...And, again, none of the petitioners' experts testified in support of that 2008 Young, Geier, and Geier study.
In summary, I conclude that all of the Geier epidemiologic studies are not reliable, and cannot be accorded any weight.
In a lengthy footnote from the decision handed down in the case of Mead v Secretary of HHS, Special Master Patricia Campbell-Smith writes,
Although the studies conducted by Dr. Mark Geier and his son purport to find an association between thimerosal-containing vaccines and autism, their studies have been criticized consistently by various reviewers, including petitioners' own expert epidemiologist, as methodologically deficient...(Dr. Rutter [characterized] the 2008 Young study—that was conducted in part by Dr. Geier and his son...as a poorly designed study for the following reasons: (1) the researchers used a "strange" study design that is both a cohort study [a controlled study] and a time-trend analysis of the available database information [an ecological study] and (2) the researchers included emotional disturbance as one of the neurodevelopmental disorders observed following exposure to thimerosal-containing vaccines even though emotional disorders are not included in any of the official psychiatric classifications systems for neurodevelopmental disorders). The undersigned has reviewed carefully the presented studies conducted by the Geiers and has considered the criticisms leveled against the Geiers' studies. Persuaded that the studies are flawed methodologically in critical respects, the undersigned, without addressing the studies in extensive detail here, declines to accord any evidentiary weight to the studies. The undersigned notes that other researchers have been unable to verify the validity of the Geiers' statistical analysis on a number of occasions and a number of courts have expressed concerns about the reliability of their work.
Campbell-Smith goes on to cite 8 court cases in which the Geiers' work was called, among other things, "unintelligible," or in which Dr. Geier's testimony was described as "not reliable."
In her decision for the third test case, Special Master Denise Vowell affords special attention to the Young, Geier, and Geier study of 2008—which was specifically pulled apart at this blog and by Epi Wonk.
The only studies demonstrating a relationship between TCVs [thimerosal-containing vaccines] and ASD [autism spectrum disorder] are those in which Dr. and Mr. Geier appear as co-authors, including the Young study published in May, 2008, and funded by the OAP PSC [Omnibus Autism Proceeding Petitioners' Steering Committee]...Because petitioners’ own expert commented that the Geier studies were not reliable as evidence... and they were thus not addressed by respondent’s experts, I do not discuss the earlier Geier studies any further. In view of the numerous criticisms of the earlier Geier studies and petitioners' own expert’s dismissal of them, I have placed no reliance on them.
The Young study was an ecological analysis using the VSD database...Doctor Greenland [petitioners' expert] did not comment on this study during his testimony, as the article was introduced after his appearance and excusal. The study found an increased risk of ASD, based on increasing exposure to TCVs. Doctor Fombonne offered several criticisms of this study. In a critique common to many of the studies performed by Dr. and Mr. Geier, Dr. Fombonne commented that the Young article did not provide the data that would allow others to verify the calculations performed.
Doctor Fombonne reproduced one chart from the article...Using the chart, he explained that the birth cohorts used in the study did not all contain the same number of individuals, with most representing 40,000 children...One birth cohort, that of children born in 1990, contains only 2,000 children...When this "outlier" is removed, the purported statistical relationship between ASD and TCVs during the first four years of the sample disappears.
Doctor Fombonne was also highly critical of the authors' addition of invented numbers to the 1995 and 1996 data from the VSD...If the adjustments are removed, there is no correlation at all between the increase in thimerosal exposure and increase in autism cases per 10,000...Doctor Fombonne commented: "It’s dishonest to impute like 45 new cases which are just invented to top up the prevalence in a way which is supportive of their hypothesis. It’s clear that these investigators have a clear track record to do with the data that supports their hypothesis. And I’ve seen that in their previous papers."
Doctor Rutter offered similar criticisms of the Young study...calling it "a poor study for several different reasons"...It began with a cohort design, but ended up being analyzed as a time trend study. That required the authors to make adjustments to the first and last cohorts. Doctor Rutter described this as "putting together chalk and cheese in the hope of gazpacho soup coming out"...The "analytic design and strategy was not a satisfactory one."
He pointed to Table 3 as a striking example of the poor design...Table 3 compares "neurodevelopmental disorders" to several control disorders, measuring the difference in rates of the disorder developing in the cohorts that received 100 micrograms more mercury. The table shows higher rate ratios for autism, ASD, ADD/ADHD, developmental or learning disorders, disturbance of emotions, and tics...Doctor Rutter called this table an example of demonstrating a statistical effect without showing a causal effect...If the neuroinflammation hypothesis is correct, it is difficult to explain how neuroinflammation causes tics or disturbance of emotions. The study reported TCV effects across a very broad range of unconnected disorders having different ages of onset, different genetic factors, and different disease courses...The broad range of effects in these diverse disorders caused Dr. Rutter to be "immediately skeptical as to what [the study] shows."
He also questioned why "disturbance of emotions" was listed in the category of neurodevelopmental disorders, noting that anyone knowledgeable about the field of neurodevelopmental disorders would not have categorized it as one, and would have placed it with the control disorders...To prove their hypothesis that increased mercury exposure causes increases in neurodevelopmental disorders but not control disorders, the authors have to demonstrate that mercury is associated with increased rates of one but not the other. If "disturbance of emotions" was properly placed with the list of control disorders, it would undercut the authors' hypothesis. Their comparison between the two groups is therefore invalid.
Vowell also comments on a reanalysis of the Young et al data by Young herself, who found no association between birth year (which was purported to be associated with exposure to TCVs) and ASD when the imputed cases were removed.
Doctor Young’s subsequently-filed letter indicated that she reanalyzed the data to respond to Dr. Fombonne's criticisms. After she removed the 1990 birth cohort (the one containing only 2,000 cases) and the notional cases for 1995 and 1996, the results for autism, ASD, and unspecified developmental disorders lost statistical significance...She nevertheless defended the use of the 1990 birth cohort and her adjustments to the numbers for 1995 and 1996.
Vowell also dismisses the study of Young et al on the basis of its funding source.
For the reasons indicated in the criticisms proffered by Drs. Fombonne and Rutter, I have accorded the Young study little weight. An additional reason for viewing this study as unreliable is the conflict of interest generated by the PSC’s funding of the study. In its opinion on remand in Daubert, the Ninth Circuit considered whether the matters an expert proposed to testify about flowed from research conducted independently of involvement in the litigation in question, noting that this factor provides objective proof that the research was conducted for scientific purposes.
Yet, despite these unequivocal, disparaging opinions on the work of Geier and Geier, they continue to find sympathetic medical publishers. Their latest article (pdf here) can be found in the Journal of Toxicology and Environmental Health, Part A, which has now published the Geiers' work on 5 occasions.
In their latest article, the Geiers (along with Janet Kern of the Genetic Consultants of Dallas) again try to link the excretion of some urinary porphyrins (their dubious pet marker for mercury toxicity) with ASD severity. The study is very similar to their previously published work in the JNS, and one wonders if there isn't substantial overlap in the study subjects (26 vs 28 children).
Despite the suspicion, the tabulated presentation of the Geiers' urinary porphyrin data in JNS (nanomoles per gram of creatinine) makes it virtually impossible to compare these numbers with their urinary porphyrin values in the latest article (which are presented in "normalized" uP levels). Similar objections can be raised of their graphed data, primarily because of differences in the presentations of the x-axes.
N.B.--The Geier studies reviewed by Special Master Hastings included the following:
On the basis of his success with The Manchurian Candidate (1962), director John Frankenheimer was able to assemble a similar behind-the scenes crew for another B&W political thriller, Seven Days in May (1964). This time, however, Rod Serling (not George Axelrod) penned the highly effective screenplay.
The movie, based on a popular novel of the same name, is the story of an attempted military coup in the United States, spearheaded by the head of the Joint Chiefs of Staff (Burt Lancaster). The planned coup is in response to a nuclear disarmament treaty signed by an unpopular President (Fredric March). Kirk Douglas plays Lancaster's right-hand military man, who alerts the Administration to his boss's overthrow plot.
The soul-searching dialog, as noted by Frankenheimer in the DVD commentary, is pure Serling:
General Scott (Lancaster): You're a night crawler, Colonel. A peddler. You sell information. Are you sufficiently up on your Bible to know who Judas was?
Colonel Casey (Douglas): I suggest you read that letter, sir. It's from the President.
General Scott: I asked you a question.
Colonel Casey (hesitantly): Are you ordering me to answer, sir?
General Scott (angrily): I am!
Colonel Casey (calmy, stoically): Yes, I know who Judas was. He was a man I worked for and admired...until he disgraced the four stars on his uniform.
Thanks to a new editorial at the Archives of Internal Medicine web site, much is being made of the high-end technology that was used to recently examine POTOS's health status. At issue, according to cardiologist Rita Redberg, the journal's editor, is the ill-advised use of 2 noninvasive screening tests—electron-beam CT (EBCT) to look for coronary calcium (a marker of coronary heart disease) and virtual colonoscopy to look for colon cancer. Redberg argued that both tests unnecessarily exposed POTOS to radiation, which increases his risk of cancer. Moreover, she maintained, their use in the President stands as a hallmark of what's wrong with the US's expensive test-heavy health care.
With respect to the criticism of screening EBCT, Redberg cited Kim et al, who estimated that the lifetime radiation-induced incidence of cancer from a single EBCT scan in a 55-year-old man is 8 per 100,000 persons. (Most of the increased cancer risk is due to an increased risk of lung cancer [6 per 100,000 persons].)* Redberg further argued that the radiation-induced cancer risk of EBCT does not outweigh the benefit of this test in low-risk persons, like POTOS. To support this contention, she cited the 2004 recommendation of the US Preventive Services Task Force, which advised against screening for coronary heart disease with resting ECG, an exercise treadmill test, or EBCT in low-risk persons.
What isn't crystal clear, however, from the USPSTF recommendation is what constitutes a low-risk person. It is generally assumed to be someone with a less-than-10% risk of MI during the next 10 years. However, it is worthy to consider whether a less-than-10% MI risk should be parsed further when the patient in question is POTOS.
Obama's risky smoking habit, the depth of which is unclear, is otherwise well known. Assuming that the President is not taking antihypertensive medication, his 10-year risk of heart attack is 7%, according to the online formula provided by the National Cholesterol Education Program. If Obama didn't smoke, his 10-year MI risk would be 3% (Plugged-in values for the online formula were taken from an AP report on President Obama's health status.)
Now: Is a 10-year MI risk of 7% low, if we're talking about the President, and Joe Biden's next in line? And Nancy Pelosi after that? While nobody's maintaining that Obama's smoking habit should take a back seat in relevance to his coronary calcium score (via EBCT), the latter information is debatably important in someone whose health affects many, many (did I stress many?) people.
The issue is not that Obama deserves superior health care, which screening EBCT evidently doesn't provide (at least on a population level, circa 2004), because he is the President; the issue is that extra measures can arguably be taken to obtain more information specifically on Obama's cardiac health, given that he is a smoker and POTOS.
Redberg also implicitly chastised POTOS's physician for ordering a virtual colonoscopy to screen for colon cancer, "even though this screening is not recommended in [Obama's] age group." Redberg again cited the USPSTF, which recommended screening for colon cancer at the age of 50 years (Obama is 48) with fecal occult blood testing, sigmoidoscopy, or colonoscopy. (You talk to most physicians, and they'll generally recommend screening colonoscopy, beginning at the age of 50 years.)
Redberg noted that the USPSTF does not recommend virtual colonoscopy for screening purposes, because of 1) a lack of supportive evidence to justify its use (again, on a population level, this time circa 2008) and 2) the unnecessary exposure to potentially cancer-inducing radiation (like with EBCT).
However, in an AP article from today, the White House countermanded Redberg by stating that earlier screening for colon cancer is sometimes recommended in high-risk groups like African Americans.** Further, the advantage of virtual colonoscopy over conventional colonoscopy is that the former doesn't require sedation, which might necessitate a transfer of Presidential power to [shudder] Joe Biden.
N.B.--It is assumed that virtual colonoscopy was performed on the President by means of CT, rather than MR. Unfortunately virtual colonoscopy, like conventional colonoscopy, requires colon preparation (and for anybody who's undergone a colonoscopy, the 24-hour prep is the decidedly unpleasant part).
* Kim et al also noted that the radiation exposure during EBCT varies widely.
** POTOS is black.
Reconstructed CT images of a colon (not Obama's) from the National Cancer Institute.
Yesterday the Senate passed another bill to postpone the mandated 21% reduction in Medicare reimbursement to physicians. The $140-million bill, passed by majority Democrats,* delays the draconian Medicare cut to October 1st and also extends unemployment benefits, COBRA subsidies, and state funding through the American Recovery and Reinvestment Act of 2009. Dissenting Republican Senators, like Jeff Sessions (AL), argue that the bill adds $100 billion to the federal deficit. The bill will now be passed on to the House for a vote.
Most recently, Republican Senator Jim Bunning (KY) stalled a bandaid bill that delayed the SGR-defined cut in Medicare reimbursement to April 1st. On March 3rd, Bunning finally relented on a vote, and the bill was immediately signed into law.
According to Medscape, this is the third time in 4 months that Congress has acted to delay the cut in the Medicare reimbursement rate. The repeated passage of stop-gap bills has been characterized by critics as "kicking the can down the road." It is hoped that the latest bill, if enacted, will allow Congress enough time to create a permanent fix to the perpetually looming drop in Medicare reimbursement.
COBRA = Consolidated Omnibus Budget Reconciliation Act; SGR = sustainable growth rate.
* In a 62-to-36 vote.
Photo of weathered can from magannie at Flickr.
Addendum: Over at MedPage Today, a poll ("How would a delay in SGR cuts without higher reimbursement rates affect your Medicare practice?") reveals that about about a third of physician respondents would continue to accept new Medicare patients, a third would refuse to accept new Medicare patients, and the remaining are not sure.
Yesterday the FDA approved Botox (onabotulinumtoxin A; Allergan) to treat distal arm spasticity in adults.* The approval was based on results from at least 3 trials in a total of 305 people with arm spasticity after stroke. Two of the 3 studies have been published in peer-reviewed journals (see here and here).
While the FDA's new approval partially mitigates the legal issue that Allergan has had with the agency's mandate to disseminate off-label safety information about Botox (for necessary background, go here, here, here, and here), it does not resolve the problem with respect to the use of Botox for limb spasticity in children—a still unapproved indication.
The case of Allergan v the United States of America et al was scheduled for a motion hearing in the US District Court for the District of Columbia on March 2nd. However, the docket has evidently been altered. According to the current court calendar, a status conference is scheduled for March 25th in the chambers of Judge John D. Bates, and a motion hearing is scheduled for April 26th.
* Specifically the flexor muscles of the elbow (eg, biceps), wrist (eg, flexor carpi radialis), and fingers (eg, flexor digitorum profundus).
Image of deep muscles of the ventral forearm from Gray's Anatomy (1918).
The Alzheimer's Association has a new report on the large and growing effect of Alzheimer disease and other dementias on Americans. Here's the distillation:
- AD is the most common cause of dementia, affecting 5.3 million Americans (1.7% of the current US population). The vast majority (96%) of those affected are older than 64 years of age.
- Dementia affects women preferentially because they live longer, on average, than men. (Advancing age is the biggest risk factor for AD.)
- In 2006, AD was the 7th leading cause of death among all Americans. In those older than 64 years of age, AD was the 5th most likely cause of death.
- Next year, the first baby boomers will turn 65. In 30 years, all of the estimated 70 million baby boomers will be older than 65. The Association estimates that there will be 1 million new cases of AD by the year 2050.
- People with AD and other types of dementia need a lot of health care, including long-term and hospice care. In 2010, care costs for people with dementia will reach $172 billion. Medicare costs for people with dementia are nearly 3 times higher than those for the nondemented elderly. Medicaid costs are nearly 9 times higher. (Blogger's note: I suspect this is the result of Medicaid-funded nursing home care.)
- Older African Americans and Hispanics are about 2 and 1.5 times more likely, respectively, to have AD and other types of dementia than older whites.* Reasons for the higher risk of AD among these minorities include a greater prevalence of known risk factors for dementia, like hypertension, diabetes, and lower education and income levels. (Ethnically dependent genetic risks have not been identified.) Despite the higher risk of dementia among African Americans and Hispanics, the diagnosis is more likely to be delayed in affected minority patients. Delays in diagnosis mean missed opportunities for treatment, which is more likely to be effective in the early stages of AD.
- Last year, nearly 11 million family members or other uncompensated persons provided 12.5 billion hours of care for people with dementia. Unpaid care was assessed at $144 billion, which is more than the US government (ie, Medicare and Medicaid) spends on people with dementia. Costs of giving care are also measured in emotional and physical stress, declining caregiver health, and lost employment-related productivity.
* This is the lead of today's press release from the Alzheimer's Association.
Photograph of atrophied brain from person with AD: National Institute on Alcohol Abuse and Alcoholism.
Trials of the monoclonal antibody ocrelizumab, a humanized version of the uber-mAb rituximab (Rituxan; Genentech/Biogen Idec), in rheumatoid arthritis and lupus have been halted because of drug-related infections and deaths. News of the grave snag in the mAb's phase 3 development (which is evidently not a huge surprise to those in the know) was announced today by the companies and reported in The Street and the WSJ. The study of ocrelizumab in multiple sclerosis, now in the phase 2 stage, continues.
Because profits from ocrelizumab would have been split 70-30, in Genentech's favor, the stalled development actually benefits Biogen Idec to some extent—because the company receives a greater share (40%) of the profits from Rituxan.* (Approval of ocrelizumab for RA, lupus, and any other condition would have eaten into Rituxan sales. A humanized mAb—meaning one that contains fewer mouse parts—is theoretically safer and provides greater long-term efficacy than a chimeric mAb, like Rituxan.)
Share prices of Roche, Genentech's owner,** are largely flat, while Biogen's stock price has climbed steadily since November for reasons that are unclear (to me). Biogen also sells the mAb natalizumab (Tysabri) and an IM version of interferon beta-1a (Avonex), both of which are FDA approved for the treatment of MS.
* An arbitration ruling over the decision-making rights for the development of ocrelizumab and Rituxan was handed down in June of last year. Net US sales of Rituxan in 2008 totaled nearly $2.6 billion. Rituxan is currently FDA approved to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and RA.
** For those emerging from long-term unconsciousness: Last year, Roche bought Genentech for $46.8 billion USD.
Image of Son of Superman comic book cover from Wikipedia.
(1948): Underappreciated noir from director Anthony Mann,* with moody voiceover narration from Claire Trevor, the Queen of Noir. A northern California setting provides the fog.
The story: Homme fatale Joe (Dennis O'Keefe) takes the prison rap for a crime boss, Rick (Raymond Burr), who owes Joe 50 Gs. Rick then sets up a prison escape for Joe, while relying on the odds that he'll get caught. But Joe escapes the police dragnet with the aid of his lovesick BFF (Trevor) and the reluctant cover of a pretty legal aid.
Despite the caliber of the film, the transfer to DVD (Classic Media) provides the bare minimum. Not even a subtitle option to catch every last drop of juicy screenplay—let alone any deserving commentary.
* Of noir and western fame.
Pharma's financial layout in 2009 for DTC ads remained, for all practical purposes, stable, when compared with 2008's numbers. According to the latest Nielson data, by way of MM&M, a total of $4.5 billion was shelled out by drug companies for ads on TV (64%), in magazines (28%), in newspapers (4%), on the web (3%), and on the radio (1%).
Here's Ye Microsofte Pie for the graphically impressed (dollar amounts are in millions).
For those who blame DTC advertising on the high cost of healthcare generally and that of drugs specifically, keep in mind that changes in DTC spending don't parallel the ever-increasing costs for drugs, outpatient care, and inpatient care.
Also costs for prescription drugs account for only about 12% of the overall healthcare spend (and are arguably one of the most cost-effective aspects of healthcare). In 2006, the spend on outpatient care was $850 billion (~41% of overall costs), and that on inpatient care was $458 billion (~22%), according to the McKinsey Global Institute.
Last year, the Congressional Budget Office reminded us that pharma invests relatively heavily in sales-rep detailing: $12 billion in 2008. The CBO's number for DTC ad spending in 2008 was $4.7 billion.
HT for lead: Pharmalot
