Prescription Drug Abuse Up– Dramatically

I wrote the other day that I was “generally suspicious of the pharmaceutical zeitgeist. And terribly so as it concerns myself.” The following, I suppose, is that zeitgeist’s underbelly. Reuters reports:

U.S. officials reported a 400 percent increase over 10 years in the proportion of Americans treated for prescription painkiller abuse and said on Thursday the problem cut across age groups, geography and income.

The dramatic jump was higher than treatment admission rates for methamphetamine abuse, which doubled, and marijuana, which increased by almost half, according to figures from the Substance Abuse and Mental Health Services Administration.

They said 9.8 percent of hospital admissions for substance abuse in 2008 involved painkillers, up from 2.2 percent in 1998. The percentage of people admitted to treatment for alcohol dropped by 5 percent and for cocaine dropped by 16 percent over the same period.

The report, which is brief and chock full of interesting charts and graphs, can be found here.

Fast Food, Childhood Obesity & the Hidden Costs of that Free Toy

Late last month, a consumer advocate group called the Center for Science in the Public Interest (CSPI) announced its intention to sue McDonald’s for using toys to market Happy Meals to children.  In an open letter to McDonald’s, CSPI litigation director Stephen Gardner alleged the toys were part of an unfair and deceptive marketing tactic which gave children “pester power” and taught them unhealthy eating habits.  Mr. Gardner further alleged the company violated Massachusetts, New Jersey, Texas, and California consumer protection laws.  Apparently McDonald’s recent Shrek 3 toy promotion was the final straw (and, somehow, the risk of cadmium exposure isn’t a concern here).  In a follow-up press release, Mr. Gardner also compared McDonald’s to:

… the stranger in the playground handing out candy to children.  McDonald’s use of toys undercuts parental authority and exploits young children’s developmental immaturity — all this to induce children to prefer foods that may harm their health.  It’s a creepy and predatory practice that warrants an injunction.

McDonald’s must decide later this month whether it will continue its Happy Meal toys or succumb to pressure.  So far the company believes that “[g]etting a toy is just one part of a fun, family experience….”

Before you completely write-off this lawsuit and characterization as over-the-top theatrics, just remember that CSPI already has a proven track record.  In 2006, the group sued KFC for using partially hydrogenated oils to deep-fry its food.  KFC subsequently switched to a trans-fat-free frying oil.  That same year CSPI also negotiated a settlement agreement with the Kellogg Company which set certain nutrition standards for marketing to children.  Better not tell CSPI about Cracker Jack and removable tattoos or Topps baseball cards and chewing gum.

In all fairness, CSPI isn’t the only group focusing on marketing to children.  Earlier this year in California, the Santa Clara County Board of Supervisors banned the inclusion of toys with meals numbering 485 calories or more.  Granted, Supervisor Donald Gage voted against the ordinance because “[i]f you can’t control a 3-year-old child for a toy, God save you when they get to be teenagers.”  The Los Angeles Times has reported on the increasing number of fast food television advertisements directed at children, particularly non-white children.  Likewise, CNN has reported on successful junk food marketing campaigns through the use of cartoon characters.  Perhaps CSPI and its supporters should go after DreamWorks and other studios whose agents negotiate these marketing agreements.  Just a thought.

This concern over McDonald’s Happy Meals and developing good eating habits in children coincides with the Trust for America’s Health (TFAH) report “F as in Fat: How Obesity Threatens America’s Future 2010.”  The report found that 38 states have adult obesity rates above 25 percent, a sharp increase from 20 years ago when no state had an obesity rate above 20 percent.  (Click here to see how your state weighs in.)  According to TFAH executive director Jeffrey Levi:

[o]besity is one of the biggest public health challenges the country has ever faced, and troubling disparities exist based on race, ethnicity, region, and income….  Millions of Americans still face barriers — like the high cost of healthy foods and lack of access to safe places to be physically active — that can make healthy choices challenging.

The report suggested a connection between income disparities and adult obesity: “35.3 percent of adults earning less than $15,000 per year were obese compared with 24.5 percent of adults earning $50,000 or more per year.”  The report also showed that “more than 12 million children and adolescents are considered obese” and half of Americans believe this is an important issue to address.  However, rather than suggesting that consumers sue fast food and junk food companies, the report recommended investing in public health initiatives and prevention programs.

I’m not a parent, so I won’t preach about better parenting skills when it comes to “pester power” and how a child’s eating habits are determined as much by their parents as the cartoon characters selling the food.  I’ll just say that there was seldom any debate with my parents over the foods that I ate as a child.  Admittedly, there sometimes are no other alternatives.  Whether you’re a high school athlete on the road, a parent with no time to make dinner, or looking for an inexpensive meal, fast food is the cheap and easy way to go.  Perhaps the key is moderation?

Does this mean CSPI should hold the fast food (and junk food) companies responsible for the development of our eating habits, from childhood to adulthood?  The TFAH report also referred to obesity liability laws in 24 states protecting restaurants, manufacturers, and marketers from weight-related lawsuits.  Take note, CSPI.  (And you, dear reader, take note of Michael Ricciardelli’s post containing some staggering numbers relating to the healthcare costs of managing Type-2 diabetes, in which obesity plays a factor, and Professor Pasquale’s beverage tax utilitarian calculus.)

Nurses, Prescriptions and Pharma Influence– Under the Radar?

Very interesting point made over at Gary Schwitzer’s Health News Review Blog regarding Industry funding of Continuing Medical Education (CME) for Nurse Practitioners (if you’ve never visited Mr. Schwitzer’s blog you should, he is informative, well written and generally brief).

Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy issued a White Paper last year, “Drug and Device Promotion: Charting a Course for Policy Reform,” which called for a cessation of industry funding of CME. The Center noted:

Reforming Funding for Continuing Medical Education (CME). Most states require physicians to undertake continuing medical education to maintain their medical license. The drug and device industry currently funds over half of the accredited CME courses available to physicians. The Center recommends that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians.

And that

• Ninety-four percent of physicians have some kind of financial relationship with industry, as reported in a major recent national study.

• Commercial support for accredited CME, nearly all of it from drug and device manufacturers, grew from $302 million in 1998 to $1.2 billion in 2006.

But what about nurse practitioners? Schwitzer, who attended the recent Georgetown Conference, “Prescription for Conflict: Should Industry Fund Continuing Medical Education?” noted that:

There are more nurse practitioners (147,000) than there are family physicians (100,000) in the US.

These advance practice nurse professionals can write prescriptions, and it’s estimated that the average nurse practitioner writes more than 6,000 a year.

And about 70-80% of those nurses who regularly attended lunch or dinner “continuing education” events sponsored by drug companies said they were more likely to prescribe the drugs that were highlighted in the lunch.

The presenter was nurse-researcher Elissa Ladd, PhD, RN, Asst. Clinical Professor, Massachusetts General Hospital Institute of Health Professions, who says the possible pharma influence on nurse-prescribers has largely flown “under the radar.”

A little quick and basic math will give us some inkling of just how much flies under that radar. We’ll use the minimum figure in all estimates. So…

147,000 Nurse Practioners each writing 6,000 prescriptions per year = 882,000,000 prescriptions. Yes, that’s 882 million prescriptions per year– conservatively estimated.

“More likely to prescribe the drugs that were highlighted in the lunch” we can estimate at 51%. We wind up with a potentially influenced 449,820,000 prescriptions. Again, conservatively estimated.

So now the only question is just what percentage or how many Nurse Practitioners “regularly attended lunch or dinner ‘continuing education’ events sponsored by drug companies?”

With a total pool of over 882 million prescriptions per year available– at least 450 million of them potentially swayed over lunch–my guess is that Pharma’s answer would be “As many as possible.”

Ethical Marketing Measures in Access to Medicines Index: An Important First Step

Earlier this week, the Access to Medicine Foundation released its 2010 Access to Medicine Index, “a ranking of the world´s largest pharmaceutical companies on their efforts to increase access to medicine for societies in need.”

In a change from the 2008 Index, which was the first to be issued, the 2010 Index includes measures designed to assess companies’ commitment to, and practice of, ethical marketing behavior.  Per the report accompanying the Index, “[t]he marketing and promotion of drugs can have a significant influence on the type of medicines that patients receive.  Particularly in Index Countries [88 countries with low or medium levels of development] with less robust regulatory enforcement and consumer protection, the marketing behavior of pharmaceutical companies can shape access to both appropriate and affordable medicines.  Unethical marketing can lead to suboptimal clinical decisions, prescription of more expensive drugs and irrational use of medicines by consumers, which can result in reduced treatment efficacy and other complications, such as adverse drug reaction and drug resistance.”

The Index ranks pharmaceutical companies’ marketing behavior along three axes: (1) commitments, (2) transparency, and (3) performance.  In the commitments category, companies are assigned points for the marketing codes and standards they have adopted and that they require their local third party sales agents to adopt.  For example, “originators,” i.e., research-based pharmaceutical companies, receive 5 points on a scale of 1-5 for committing to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Pharmaceutical Marketing Practices, the WHO Ethical Criteria for Medicinal Drug Promotion, “or an equivalent industry code.”  Originators that have not committed to any external codes but that have an internal code which covers the same core principles receive 2.5 points.  (The scoring is different for generics on this measure because they do not have a “viable up to date and auditable external code.”)  With regard to third party sales agents, both originator and generic companies can receive all 5 points if they make “specific ethical marketing demands” of their sales agents and then audit the agents’ practices to ensure compliance.

For transparency, the Index gives points to companies that “publicly disclose[] detailed information regarding [their] marketing and promotional programs in the Index Countries, such as payments to physicians or other key opinion leaders and also its promotional activities for other healthcare providers, distributors, etc.”  None of the companies earned any points in this category.  While some have started to disclose payments made in the United States, no company has disclosed payments made in any of the Index Countries.  According to the report, three companies — GlaxoSmithKline, Merck, and Roche — have pledged to disclose payments made in the Index Countries soon.  Companies can also earn disclosure points for revealing breaches of marketing codes and marketing-related litigation in the Index Countries.

For the third category, performance, companies lose points if they breach the IFPMA Code or if they are sued or subjected to fines for marketing behavior.  Companies can earn points for including binding ethical marketing requirements in their agreements with their sales agents and by establishing employee codes of conduct in the Index Countries equivalent to the codes they have in place in other markets.  Despite the fact that issues have been raised “about pharmaceutical marketing practices in the Index Countries, especially regarding clear mention of … adverse side effects,” none of the companies studied lost any points in this category.

As the title of this post suggests, I think that the Index’s attempt to rank companies’ commitment to and practice of ethical marketing practices is important.  Anyone who works in a law school knows how influential rankings can be — for better or for worse.  It is easy to imagine the Access to Medicine rankings providing an additional nudge to companies to begin disclosing payments to healthcare providers around the world not just here in the United States.  At the same time, there is ample room for refinement.  In the performance category, for example, measures, in addition to breaching the IFPMA Code/being sued/ being fined, are needed to expose differences that surely exist in companies’ approaches to marketing in the Index Countries.

Survivors’ Costs Gone Wild, Beverage Tax Edition

Gradgrind is alive and well, as this exchange on soda taxes explains:

This discussion between Greg Mankiw and David Leonhardt reads a bit like an economics textbook gone rogue. At issue is whether a soda tax makes sense. David Leonhardt says it does: There’s good evidence that it will reduce obesity, which will reduce health-care costs. Au contraire, says Mankiw: You have to “net out the appropriate budgetary savings from shorter lifespans.” In other words, maybe it’s not worth it, as the obese live shorter lives and so cost the government less.

Ezra Klein goes on to describe how the calculation of survivors’ costs (without offsetting valuation of survival benefits) “disadvantages the quality/value agenda as compared with the cost-control agenda.”

I would add a couple more points to complicate the analysis:

First, Mankiw may be interested in exploring the benefits of the “plus-size” clothing market. As the NYT reports, “The plus-size market increased 1.4 percent while overall women’s apparel declined 0.8 percent in the 12 months leading up to April 2010 versus the same period a year earlier, the most recent figures available, according to NPD Group, a market research firm.” Certainly taxes that discourage the development of this growth industry should be scrutinized carefully.

Second, for team Leonhardt, we might think of the tax as a way of deterring anti-beverage tax ads which have glutted the tri-state airways over the past few months. We could all do with a little less of the rent-seeking featured below:

Bad Ads and Doctor Deputies

Earlier this month, the FDA launched a new initiative — the Bad Ad Program — to “help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”  In an article appearing earlier this week in Advertising Age, advertising executives and others decry the program as a “publicity stunt” with the potential to lead to physician “vigilantism” and to become “unbridled and messy.”  Also quoted in the article is PhRMA Senior Vice President Ken Johnson, who states that PhRMA views the Bad Ad Program as “another step to help educate — and receive feedback from — healthcare providers about prescription drug advertising and promotion.”  The Advertising Age article, correctly I think, characterizes this statement as offering only “tepid support.”

There appear to be two central criticisms of the Bad Ad Program: (1) that it is not as low-cost as it seems because it will take up physicians’ time and create more work for the FDA’s already overburdened Division of Drug Marketing, Advertising, and Communications (DDMAC) and (2) that it will be an ineffective compliance tool either because doctors cannot tell the difference between compliant and noncompliant advertising or because doctors will “go on personal jihads on ads they don’t like - ads that very well might be in perfect compliance.”

Both concerns seem overblown.  Doctors do not have to participate if they do not have the time or inclination — it seems likely that most will not — and pharmaceutical companies have been reporting each other’s marketing abuses to DDMAC for years, so the Division has experience sifting through more and less credible information.  Doctors may well have difficulty discerning which ads are compliant and which are not — see, e.g., this study revealing that doctors could not accurately identify the FDA-approval status of a significant percentage of the drugs they prescribe — but this is not an argument against the FDA’s effort to educate them.

The bottom line is that while pharmaceutical companies track what happens in physician offices in multiple ways, including through sales rep call notes and sales message recall studies, they do not, at least not consistently and/or voluntarily, use the information gathered in service of compliance, as opposed to sales, goals.  In the words of Arnie Friede, to the extent that the FDA’s Bad Ad Program creates “an additional incentive for a company to closely monitor and control communications by their sales people” it is “an understandable, perhaps even brilliant move.”

Why You Should Never Mix Two Kinds of Drain Cleaner Together

This article is not so much a health reform post as it is perhaps a public service announcement–or a warning.  Two weeks ago I found myself sitting in an Emergency Room hooked up to a steady stream of oxygen; the recipient of various and sundry breathing treatments.  My follow-up visit to the doctors’ brought more breathing treatments, a steroid prescription, and the assurance that the x-rays showed that my lungs had suffered no permanent damage and that my breathing would return to normal in a week or two to a month. For the most part, it has.

The culprit? Drain cleaners–specifically:  two kinds inadvertently mixed. I heaved and coughed and choked as though my lungs were on fire for almost an hour before I made my way to the hospital. I simply could not breathe, and breathing itself was (and remained for almost a week) painful. But I kept my head, and remembered to bring the offending chemicals with me.

To make a long story short, the sink upstairs in my old house was clogged. I purchased a nondescript drain cleaner which contained hydrochloric acid. Unbeknownst to me, my upstairs tenant had already poured drain cleaner in the sink but did not tell anyone. When I made my way to the sink, it was filled with a pool of blue liquid. On the sink counter was a bottle of blue liquid hand soap. I assumed that the liquid filling the the sink was the blue hand soap mixed with water which would not drain. I was wrong, and dangerously so.  The blue liquid was another kind of drain cleaner; it contained sodium hypochlorite–which is bleach.

Apparently, the combination of hydrochloric acid and sodium hypochlorite (bleach) creates chlorine gas–which was used for chemical warfare early in World War I, a precursor to mustard gas. The following passage, culled from a few different sources will relay the pertinents  better than I can:

Concentrated hydrochloric acid (fuming hydrochloric acid) forms acidic mists. Both the mist and the solution have a corrosive effect on human tissue, with the potential to damage respiratory organs, eyes, skin, and intestines. Upon mixing hydrochloric acid with common oxidizing chemicals, such as sodium hypochlorite (bleach, NaClO) or potassium permanganate (KMnO₄), the toxic gas chlorine is produced.

Chlorine is a toxic gas that irritates the respiratory system. Chlorine is detectable in concentrations of as low as 0.2 ppm. Coughing and vomiting may occur at 30 ppm and lung damage at 60 ppm. About 1000 ppm can be fatal after a few deep breaths of the gas.^[4] Breathing lower concentrations can aggravate the respiratory system, and exposure to the gas can irritate the eyes.^[47]

Chlorine’s toxicity comes from its oxidizing power. When chlorine is inhaled at concentrations above 30ppm it begins to react with water and cells which change it into hydrochloric acid (HCl) and hypochlorous acid (HClO).

Chlorine gas, also known as bertholite, was first used as a weapon in World War I by Germany on April 22, 1915 in the Second Battle of Ypres. As described by the soldiers it had a distinctive smell of a mixture between pepper and pineapple. It also tasted metallic and stung the back of the throat and chest. Chlorine can react with water in the mucosa of the lungs to form hydrochloric acid, an irritant which can be lethal. The damage done by chlorine gas can be prevented by a gas mask, or other filtration method, which makes the overall chance of death by chlorine gas much lower than those of other chemical weapons. It was pioneered by a German scientist later to be a Nobel laureate, Fritz Haber of the Kaiser Wilhelm Institute in Berlin, in collaboration with the German chemical conglomerate IG Farben, who developed methods for discharging chlorine gas against an entrenched enemy. It is alleged that Haber’s role in the use of chlorine as a deadly weapon drove his wife, Clara Immerwahr, to suicide. After its first use, chlorine was utilized by both sides as a chemical weapon, but it was soon replaced by the more deadly gases phosgene and mustard gas.^[40]

I was exposed to the blue pool of gas for about ten minutes all told as I attempted to clear the sink in various ways. At first I believed that the irritation and coughing was being caused by the drain cleaner merely doing its work, and that I had just gotten an untoward whiff. Later, when I saw the offending bottle of drain cleaner tucked away in the corner and realized I had mixed two kinds of poison together  I got air but had to go back to bail out the liquid so it would not continue to emit the gas and  endanger others. I warned my son, gave him both bottles of drain cleaner and told him I had inhaled the gas from them, that I had to go back upstairs to clear the sink, and that if something were to happen to me he was to call 911, tell them what happened and give them the bottles of drain cleaner. I didn’t pass out.

The vicious coughing, inability to breathe, and pain got considerably worse in the next half hour. The oxygen and breathing treatments at the hospital helped a great deal, as did those I received at the doctors’ next day. The worst of it lasted about 4 days, though now I’m almost entirely back to snuff.

The truth is, I know to not mix two kinds of drain cleaner together, but made an incorrect and costly assumption regarding the origin of the blue liquid. But as I’ve told this story over the last two weeks, I was surprised at how many people did not know. Thus this post.

Having said that, although I did know that one wasn’t supposed to mix these common household products together, I certainly didn’t know that doing so could create a gas so toxic it was once used for chemical warfare. And having said that, not to let the J.D. at the end of my name take over, but the warnings on the labels of these two products which are sold right next to each other come nowhere close to expressing the magnitude of the harm of which they are capable of in combination. The small type letters on the back of the bottle would do far better service as large letters highlighted by a skull and crossbones on the front. More effective labeling could, I believe, without significant cost have a significant impact on health and safety.

Comment on Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions (Parts III & IV)

[Ed. Note: This post is a continuation of a post we published the other day regarding "modifications and additions to initial marketing regulations implementing The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("MMA"), which "established the Medicare Prescription Drug Benefit Program (Part D) and made revisions to [] provisions” of the Medicare Advantage Program.” The initial post, detailing the modifications, can be found here.]

By Michael Rabasca

PART III

The strongest argument against these final regulations is that they prevent eligible enrollees “from learning about their full range of healthcare options” and, thus, unduly hinder the market for Part C and Part D plans. (Federal Register, Volume 73, No. 182 at p. 54214). In order for consumers to make informed healthcare decisions, they need to have ready access to information. Marketing is all about the strategic distribution of information, and placing restrictions on plan marketing activities limits the information available to potential enrollees. Thus, regulating the marketing activities of Part C and Part D plans could lead to consumer ignorance and severely limit the choices of Medicare eligible individuals.

These new rules significantly hinder the ability of potential Part C and Part D plan participants to both obtain plan information and enroll in plans. Many individuals who are eligible for Medicare are hospitalized or living in nursing homes where healthcare is delivered. Under these rules, Part C and Part D plans would be unable to make marketing presentations, distribute enrollments applications, or collect completed applications from these individuals. Unfortunately, these potential enrollees are often the people who would benefit the most from enrolling in these plans and these regulations severely limit their ability to do so.

PART IV

I think that government oversight of Part C and Part D plans’ marketing activities provides vital protection to the individuals who are eligible to participate in these plans. I feel that Medicare participants are particularly vulnerable to questionable marketing practices, and these final regulations provide important modifications and additions and to CMS’s marketing regulatory scheme. Nevertheless, I am not convinced that these rules do enough to deter Part C and Part D plans from engaging in impermissible marketing activities. Although CMS may impose civil monetary penalties or marketing/ enrollment sanctions on plans that violate its marketing regulations, these penalties are merely discretionary. I agree with one commenter who suggested that CMS should mandate civil monetary penalties for plans that violate the marketing rules in order to ensure that violators are punished. (Federal Register, Volume 73, No. 182 at p. 54211). Additionally, I feel that CMS should provide some sort of financial incentive for both individuals and competing plans who report marketing violations in order to increase the likelihood that violations are discovered and reported. These additional enforcement tools would help to ensure that the new final marketing regulations serve their purpose by effectively protecting individuals who are eligible to participate in Part C and Part D plans from inappropriate marketing tactics.

Comment on Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions (Parts I & II)

By Michael Rabasca

Part I

These rules represent modifications and additions to initial marketing regulations implementing The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (”MMA”), which “established the Medicare Prescription Drug Benefit Program (Part D) and made revisions to [] provisions” of the Medicare Advantage Program (Part C). (Federal Register, Volume 73, No. 182 at p. 54208). The Centers for Medicare and Medicaid Services’ (”CMS”) enacted these final regulations pursuant to §§ 1851(h) and 1860D-1(b)(1)(B)(vi) of the Social Security Act, which empower the CMS to “implement standards consistent with ‘fair marketing.’” (Federal Register, Volume 73, No. 182 at p. 54210).

The most significant aspect of these final regulations is the new restrictions they place on Part C and Part D plans’ marketing activities. Specifically, these rules prohibit the following:

(1) unsolicited direct contact with potential enrollees, including telemarketing (42 C.F.R. §§ 422.2268(d), 423.2268(d));

(2) selling non-healthcare related products during a plan marketing event or presentation (42 C.F.R. §§ 422.2268(f), 423.2268(f));

(3) conducting marketing presentations or distributing and/or collecting enrollment applications “in provider offices or other areas where healthcare is delivered to individuals, except . . . where such activities are conducted in common areas in healthcare settings” (42 C.F.R. §§ 422.2268(k), 423.2268(k));

(4) conducting marketing presentations or distributing and/or collecting enrollment applications at “educational events”  (42 C.F.R. §§ 422.2268(l), 423.2268(l)); and

(5) offering meals to potential plan enrollees at marketing events (42 C.F.R. §§ 422.2268(p), 423.2268(p)).

These regulations also implement new rules regarding CMS’s procedure for reviewing Part C and Part D plan marketing materials. Generally, Part C and Part D plans must submit all marketing materials to CMS at least forty-five days before distribution. (42 C.F.R. §§ 422.2262(a), 423.2262(a)). However, the regulations provide for an abbreviated “file and use” procedure, under which CMS deems certain materials approved five days after submission. (Federal Register, Volume 73, No. 182 at p. 5410). Previously, Part C plans could use the “file and use” procedure to obtain approval of marketing materials if: 1) the plan had a record of continued exemplary performance in CMS reviews of its marketing materials; or 2) the plan certified that the marketing materials in question did not contain “substantive content” or, alternatively, only used “model language already reviewed and approved by CMS.” (Federal Register, Volume 73, No. 182 at p. 54210).  Part D plans, on the other hand, could only obtain “file and use” approval through plan certification. (Federal Register, Volume 73, No. 182 at p. 54210). However, these final regulations “eliminate file and use status based on an organization’s track record” for Part C plans, and implement “a uniform policy of applying the file an use policy to marketing materials that either use model language without substantive modification, or materials identified by CMS as not containing substantive content warranting CMS review” for both Part C and Part D plans. (Federal Register, Volume 73, No. 182 at p. 54210-54211).

Additionally, these final regulations implement licensure requirements for plan marketing representatives. Specifically, the rules require Part C and Part D plans to exclusively use State licensed marketing representatives to conduct direct marketing activities targeted at potential plan enrollees. (42 C.F.R. §§ 422.2272(c), 423.2272(c)). Plans must also notify states that they are using licensed representatives in a manner that is “consistent with the appointment process provided for under State law.” (42 C.F.R. §§ 422.2272(c), 423.2272(c)).

Finally, these rules mandate that Part C and Part D plans make certain disclosures to plan participants. Under these final regualtions, plans must now disclose the information specified in §§ 422.111(b) and 423.128(b) to all plan participants both “[a]t the time of enrollment and at least annually thereafter, 15 days before the annual coordinated election period.” (42 C.F.R. §§ 422.111(a)(3), 423.128(a)(3)).

PART II

The best argument in support of these final regulations is that they provide necessary consumer protections. Generally, individuals age sixty-five and older, and people with disabilities are eligible for Medicare programs. This group of potential enrollees is particularly vulnerable to dubious marketing tactics. Allowing insurers to market their Part C and Part D plans unchecked could be harmful potential participants. Indeed, permitting plans to distribute information and solicit enrollment applications at any place and in any manner they chose has the potential to confuse potential enrollees and, in some cases, could result in plans coercing individuals into participating. Thus, a free market philosophy as to plan marketing practices is inappropriate in the Part C and Part D setting, and strict regulation is required.

These new rules protect consumers by: 1) prohibiting certain problematic marketing activities; and 2) limiting the places where plans may conduct marketing activities. Indeed, prohibiting Part C and Part D plans from offering meals or selling non-healthcare related products to potential participants prevents hurried “enrollments without personal attention to the appropriateness of the plan.” (Federal Register, Volume 73, No. 182 at p. 54215). Additionally, prohibiting plans from conducting marketing activities and soliciting enrollments at educational events and anywhere healthcare is delivered prevents plans from targeting individuals for enrollment when they are vulnerable to suggestion, and avoids the appearance that individual providers and facilities recommend or support specific plans.

Pharma Marketing, Advanced

With the Senate’s bill clearing late night hurdles, the coverage in the mainstream media is, at least for the moment, broad. But there was a segment on NPR’s All Things Considered in the midst of all that Health Reform bill coverage that is well worth a listen. The segment, “How A Bone Disease Grew To Fit The Prescription,” (transcript linked, audio below) functions as a sort of biography of the evolution of both a drug and a disease– which was not, it seems, an entirely independent process.

The drug is Merck’s Fosomax, the disease is Osteopenia. Fosomax had sales in 1996 of $281.8 million; by 2005, on the heels of what qualifies as a comprehensive and wildly successfull marketing effort, the drug had sales of $3.2 billion.  Osteopenia derives its origin as somewhat of an afterthought, when in 1992 “a group of osteoporosis experts gathered under the auspices of the World Health Organization” and drew a somewhat arbitray bright line to determine what level of bone mass loss was normal and what amount constituted a disease. The term “Osteopenia” was coined, on the spot, to give clinical researchers a term which described those whose bone loss was considered normal, but was close to the line. They never imagined that Osteopenia would come to be considered a disease in itself, but it did. Millions of women are said to have it; millions treat it with Fosomax. The story of how this came to be (and the implications regarding the role of Pharma in health care) is fascinating.

“You’re Going to Die”: the “Paranoid” Style of Reform Opposition

An AP story on Wednesday quoted Tom Coburn, a Republican Senator and former obstetrician, addressing the reform bill’s Medicare cost-containment provisions, and delivering a message to seniors:  “I have a message for you: you’re going to die sooner.”  Some Democrats, such as Senator Pat Murphy, are clearly frustrated that Republican Senators, having opposed many recent Medicare improvement measures (see MIPPA 2008, which expanded primary care and suspended a scheduled cut in physician reimbursement), now cast themselves as the pro-Medicare party.  And standing with Coburn was Senator McCain, whose ‘08 presidential campaign argued for health reform financed in part with savings from Medicare and Medicaid.

The health reform bills contain interlocking provisions concerning coverage, finance, and delivery reform.  I doubt that any two thoughtful people would agree on every aspect of the current bill.  Comments of two sorts seem in order under these circumstances  (and hopefully are reflected in the posts on this site):  specific comments providing reasoned support or opposition to particular provisions and/or proposing amendments thereto, or general and reasoned comments supporting or opposing the overall package.  Coburn’s comment fits most nearly into the second category, but “reasoned” it ain’t.  It made me think of the classic Richard Hofstadter essay, The Paranoid Style in American Politics. (H/t to CBC’s Ideas, broadcast on November 28, podcast available here.)  Hofstadter, a Pulitzer Prize-winning Columbia University historian and commentator on American anti-intellectualism, wrote in his 1964 essay of the dark tradition in American politics of outrageous argumentation calculated to see “how much political leverage can be got out of the animosities and passions of a small minority.”  He was clear that he was not using “paranoid” in a clinical sense, but instead as a label to evoke a “sense of heated exaggeration, suspiciousness, and conspiratorial fantasy.”

Hofstadter was clear that the “paranoid style” was not used only by one movement, or even by only one slice of the American political spectrum.  He argued that examples could be found on the left and the right, and on both sides of many major issues.  It is not Coburn’s position that harkens to Hofstadter’s characterization of irresponsible speakers.  Rather, it is the style of his speech.  Hofstadter explained it this way:

Of course this term is pejorative, and it is meant to be; the paranoid style has a greater affinity for bad causes than good. But nothing really prevents a sound program or demand from being advocated in the paranoid style. Style has more to do with the way in which ideas are believed than with the truth or falsity of their content.

American history is filled with examples of political spokespersons resorting to this sort of extreme speech:

In the history of the United States one finds it, for example, in the anti-Masonic movement, the nativist and anti-Catholic movement, in certain spokesmen of abolitionism who regarded the United States as being in the grip of a slaveholders’ conspiracy, in many alarmists about the Mormons, in some Greenback and Populist writers who constructed a great conspiracy of international bankers, in the exposure of a munitions makers’ conspiracy of World War I, in the popular left-wing press, in the contemporary American right wing, and on both sides of the race controversy today, among White Citizens’ Councils and Black Muslims.

Joining all of these examples together are several factors: extreme overstatement; the use of specific “facts” as the basis for factually unsupportable positions; and the apparent intent to inflame rather than reason.  There are of course, examples of such political speech today on the right and left.  It is no longer surprising — although regrettable — to hear simplistic and hateful comments from “entertainers” and “commentators” on cable news and talk radio programs.

But Colburn is not an entertainer.  He is in a leadership position in the United States Senate.  He might speak factually — rhetorical flourishes and all — about aspects of the bill with which he disagrees.  He might forcefully explain why he believes Americans should decide that we’d be better off without this version of health reform.  Instead, he has taken himself out of the discourse, and has used “factual” arguments for the purpose of misleading and inflaming.  He has, in short, removed himself from reasoned debate and embraced the demagoguery decried by Hofstadter.  Americans deserve better from our Senators.

The FDA Steps In: Regulating Prescription Drug Promotion on the Internet

The FDA has been widely criticized for not providing guidance for drug companies eager to promote their products on the internet.  Earlier this year, the FDA expressed the view that the message was what was important, not the medium, meaning that companies should simply apply the rules governing prescription drug advertising in print media to the internet.  On April 2, 2009 the agency issued Notice of Violation letters to 14 companies who sponsored links on internet search engines advertising their products; the links gave the name of the drug and, in some cases, its indicated use, without including the required “fair balance,” i.e., safety information such as contraindications and potential side effects.  In reliance on the so-called “one-click rule” — which had never actually been adopted by the FDA — the companies had put the required safety information one click away on a separate page.

In recent months, the FDA has indicated that it is open to providing internet-specific marketing guidance.  Yesterday and today (November 13^th) the agency is holding a hearing on “Promotion of FDA–Regulated Medical Products Using the Internet and Social Media Tools.”  Representatives from advertising agencies, consumer groups, health-related websites, pharmaceutical companies, and search engines are scheduled to testify.

In written testimony released before the hearing, PhRMA, the pharmaceutical industry’s trade group, proposed that the FDA approve a standard universal warning: PhRMA suggests “All drugs have risks.  Click here for more information from the manufacturer.” — for use “in places throughout the Web where there is not enough room for complete disclosure of all warnings, indications, and contraindications (e.g., search results and microblog posts.)”  Such a warning would, PhRMA argues, allow companies to take advantage of sponsored links, make full use of Twitter, etcetera, while also providing easy access to safety information.  PhRMA even suggests that the warning incorporate the FDA’s logo, arguing that this could mitigate against “the dangers posed by illegal Internet drug sellers.”

It will be interesting to see whether and how the proposals of the other groups represented at the hearing differ from PhRMA’s, and, of course, whether the FDA in the end decides that its “fair balance” requirements should be modified for the web.  Among the other interesting issues FDA may address is companies’ responsibility for web content they do not control.  Google’s introduction of Sidewiki, which allows anyone visiting a pharmaceutical company’s website to leave a comment, has brought this issue to the fore, raising, for example, the prospect of doctors discussing a product’s off-label uses on the manufacturer’s site.

Anyone who wishes to comment on these or other internet-specific promotion issues may do so through February 28, 2010.

Under the Radar: Health Care Reform & Drug Advertising & Marketing

At the Food and Drug Law Institute’s 21^st Annual Advertising & Promotion Conference John Kamp of the pro-industry Coalition for Healthcare Communication discussed four proposals addressing drug advertising and marketing issues that may be incorporated into the final health care reform bill but have not been widely debated.  Mr. Kamp’s presentation is available here.  

Off the Table (For Now)

Of most concern to industry is an oft-floated proposal to eliminate the tax deduction for drug advertising.  (See, for example, bills sponsored by Representative Jerrold Nadler (D-NY) and Representative Daniel Lipinski (D-IL) here and here.)  Most recently, on September 11, 2009 Senator Bill Nelson (D-FL), a member of the Senate Finance Committee, announced his plan to put forth an amendment to the Baucus Bill that would eliminate the “tax break drugmakers get for TV advertising.”

Direct-to-consumer advertising is a prime target because, as the New York Times put it, for many “the ads are a daily reminder of a health care system run amok,” which “prompt people to diagnose themselves with chronic quality-of-life problems like insomnia or restless leg syndrome; lead people to pressure their doctors for prescriptions for expensive brand-name drugs to treat these conditions; and steer people away from cheaper generic pills.”   There is also concern that DTC ads do not present an accurate picture of drug risks and benefits and that they drive uptake of new drugs before their safety is fully known.

Another obvious driver is the need to pay for health care reform.  Senator Nelson echoed a claim made earlier this year by Congressman Charles Rangel (D-NY) that eliminating the tax break for TV ads would free up $37 billion over the next ten years.  Industry representatives contest the $37 billion figure, arguing that drug companies spend far too little on direct-to-consumer advertising to achieve that level of additional tax revenue.  They contend that Congress would have to eliminate the tax deduction for physician advertising and other marketing expenditures to garner $37 billion.

Less than a week after he announced it, Senator Nelson backed off his plan, perhaps under pressure from other members of Congress who come from districts with a strong media presence and have spoken out against eliminating the deduction.  According to Mr. Kamp, however: “Somebody else will raise this again before it’s over, you bet … Baucus says the reforms will cost $850 billion, the Congressional budget office $750 billion. Three-quarters of a trillion dollars is a lot of real money in Washington. The $37 billion will continue to be in the buffet of options as they try and figure out healthcare.”  

Still on the Table

Three proposals related to drug and device promotion are still on the table, with varying chances for inclusion in the final health care reform bill.

First, health care reform bills in both the House and the Senate contain transparency provisions akin to those in the Physicians Payments Sunshine Act of 2009 introduced in January by Senator Chuck Grassley (R-IA).  Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy recommended that disclosure of drug and device company payments to doctors be federally mandated in its January 2009 white paper.  As the Sunshine Act has widespread support, including from industry, transparency provisions are likely to be included in the final bill.

Second, Section 138 of the health care reform bill reported out of the House Education and Labor Committee   bans the commercial use of “prescription information containing patient identifiable and prescriber identifiable data,” essentially adopting as federal law New Hampshire’s ban on prescription data mining which survived a First Amendment challenge in the First Circuit.  If passed, Section 138 would end drug reps’ current practice of tailoring their sales messages to each doctor’s prescribing history, which many believe creates undue pressure on doctors to prescribe newer more expensive medications.

Third, a bill sponsored by Senator Jack Reed (D-RI) would authorize the FDA to evaluate whether use of a “drug facts box” format for presenting a drug’s benefits and risks would improve healthcare decision making and, if so, to promulgate regulations requiring that drug facts boxes be added to drug labels.  Senator Reed’s bill also empowers the FDA to set standards for comparative clinical effectiveness information included in drug labeling and advertising.

It is difficult to predict whether the data mining ban or Senator Reed’s bill will be included in the final health care reform bill.  Mr. Kamp calls Senator Reed’s bill’s chances a “toss up;” regarding the data mining ban, he has “no idea.”

What “Free Markets” Really Look Like

In health reform, as so many continue to extol the virtues of an unfettered private market– a “free market” if you will–it may be of some help to consider just what a free market is. What that calculus entails. Considered by many as the theoretical underpinning of the modern market (though, as Professor Frank Pasquale has noted, the economics of Health Care are decidedly “unconventional”) the work of Adam Smith is worth considering. Smith championed self-interest as the best means to societal benefit. “Self-interested competition in the free market, he argued, would tend to benefit society as a whole by keeping prices low, while still building in an incentive for a wide variety of goods and services.”  In Robert L. Heilbroner’s, “The Worldly Philosophers: The Lives, Times, and Ideas of the Great Economic Thinkers, we may find the following:

To Adam Smith, laborers, like any other commodity, could be produced according to the demand. If wages were high, the number of workpeople could multiply; if wages fell, the numbers of the working class would decrease. Smith put it bluntly: “…the demand for men, like that for any other commodity, necessarily regulates the production of men.”

Nor is this quite so naïve a conception as it appears at first blush. In Smith’s day infant mortality among the lower classes was shockingly high. “It is not uncommon,” says Smith, “… in the Highlands of Scotland for a mother who has borne twenty children not to have two alive.” In many places in England, half the children died before they were four, and almost everywhere half the children lived only to the age of nine or ten. Malnutrition, evil living conditions, cold, and disease took a horrendous toll among the poorer element. Hence, although higher wages might have affected the birth rate only slightly, they could be expected to have a considerable influence on the number of children who would grow to working age.

Hence, if the first effect of accumulation would be to raise the wages of the working class, this in turn would bring about an increase in the number of workers. And now the market mechanism takes over. Just as higher prices on the market will bring about a larger production of gloves and the larger number of gloves in turn press down the higher prices of gloves, so higher wages will bring about a larger number of workers, and the increase in their numbers will set up a reverse pressure on the level of their wages. Population, like glove production, is a self-curing disease-as far as wages is concerned.

And that is the free market calculus with regard to working people. Higher wages equals more food, better shelter and medical care and more babies living which in turn will produce more workers which in turn will force that greater number of living workers to compete for jobs which will then lower wages. Those lower wages will then produce less food, worse shelter, and less medical care which will produce less babies living– which in turn will produce less workers. A cycle of sweat, blood and tears unencumbered by the “distortions” of regulation.  That is the “human element” of a sheer free market calculus for workers. No regulation, no aid to dependent children or social security, no FDA–just the invisible hand of the market– that most efficient of instruments– “correcting itself” through infant mortality.

So as pundits, tea bag protesters and blog commenters across the nation call out in favor of “private markets,” “free markets” and the like, let us realize that few have the stomache for an actual pure free market. As is as it should be. So when we talk about governmental intervention in the market– let us be clear: we speak only of extent and degree– not principle.

This passage from Dickens, remembering life as a 12 year old boy working ten hours per day, 6 days per week in  early 1800’s industrial England gives some view of life under a veritable Laissez-Faire free market, as do many of his books:

As told to John Forster (from The Life of Charles Dickens):

Dickens at the Blacking Warehouse

The blacking-warehouse was the last house on the left-hand side of the way, at old Hungerford Stairs. It was a crazy, tumble-down old house, abutting of course on the river, and literally overrun with rats. Its wainscoted rooms, and its rotten floors and staircase, and the old grey rats swarming down in the cellars, and the sound of their squeaking and scuffling coming up the stairs at all times, and the dirt and decay of the place, rise up visibly before me, as if I were there again. The counting-house was on the first floor, looking over the coal-barges and the river. There was a recess in it, in which I was to sit and work. My work was to cover the pots of paste-blacking; first with a piece of oil-paper, and then with a piece of blue paper; to tie them round with a string; and then to clip the paper close and neat, all round, until it looked as smart as a pot of ointment from an apothecary’s shop. When a certain number of grosses of pots had attained this pitch of perfection, I was to paste on each a printed label, and then go on again with more pots. Two or three other boys were kept at similar duty down-stairs on similar wages. One of them came up, in a ragged apron and a paper cap, on the first Monday morning, to show me the trick of using the string and tying the knot. His name was Bob Fagin; and I took the liberty of using his name, long afterwards, in Oliver Twist.

“You’re not being Bipartisan.” “No, You’re not being Bipartisan.”

The Obama administration and the gang of six’s Republican Senators Charles Grassley and Mike Enzi continue to trade barbs about who is “not being bipartisan.”

The latest response comes from Senator Grassley responding to David Axlerod who had responded to statements Senators Grassley and Enzi had made over the summer recess.

Mr. Axlerod had the temerity on Monday to accuse the Senators of “negotiating in bad faith,” offering that the Senators actions suggested “that they don’t want to participate” in bipartisan talks. Mr. Axlerod further stated:

“If you’re sitting at a table negotiating in good faith, then you probably don’t send out mailers saying, ‘Help me stop Obama-care.’ That’s just common sense.”

According to A.P.,

Enzi, in a radio address Saturday, said Democratic proposals would restrict medical choices and make the country’s “finances sicker without saving you money.”

In an August fundraising letter, Grassley asked for “support in helping me defeat Obama-care.” He said Democratic-drafted bills would be “a pathway to a government takeover of the health care system.”

Far be it from me to define “bipartisan cooperation,” but I must admit “Help me defeat Obama-care” doesn’t really seem to capture the essence of that spirit.

Jill Kozeny, a spokeswoman for Senator Grassley defended the statement saying, according to A.P., that “Grassley was simply restating his well-known opposition to a government-run health insurance plan.”

In addition, Ms. Kozeny in turn responded to Mr. Axlerod’s  accusation as follows:

“Attacks by political operatives in the White House undermine bipartisan efforts and drive senators away from the table,” but added that “the so-called “Group of Six” senators would continue to work for a compromise despite his comments.”

Having been in a schoolyard tussle or two in my time, I can’t help but feel the similarity as each side accuses the other of failing to be “bipartisan.” As a kid growing up in the late sixties and seventies in working class New Jersey, schoolboys everywhere labored under the same admonition from our fathers: “Don’t you start a fight–but if anyone hits you first–or says something about your Mother–you can hit him.” Except for the truly spontaneous outbreaks, most fights (or putative fights) began with ten or twenty minutes of some form of verbal interchange designed to try to get the other guy to throw the first punch, followed by shoving, and then–if no one broke it up–a fight.

And I’m not entirely sure which category “You’re not bipartisan.” “No, you’re not bipartisan” fits (though I suppose there’s no question as to where all that talk about “pulling the plug on grandma” belongs) –but as I’ve said, the similarity to schoolboys trying to engage in a tussle without blame is keen–far too keen. It would be funny–if it weren’t for all those sick people and the fact that we somehow manage to spend considerably more for health care and get considerably less than most everyone in the world.

Obama is said to be scheduled to address Congress about Health Care Reform on prime-time television come the Wednesday after Labor Day. Maybe he can break it up. If not, it might be time to start shoving– or at least twisting some arms– LBJ style.

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