The Government Accountability Office released a report today, finding that “in several key areas, FDA rules for drug approval fail to guarantee the safety and effectiveness of drugs for seniors.” Among the problems identified:

• Inclusion of seniors in clinical trials. GAO found that drug manufacturers “generally included elderly persons and reported safety and effectiveness data for elderly persons in clinical trials.” However, in a number of cases, selected drug trials excluded participants on the basis of age, restricting the participation of seniors.
• Inadequate FDA guidance. FDA has failed to clarify important requirements in the drug evaluation process for seniors, resulting in potential information gaps. For example, FDA does not require that medical officers determine whether a sufficient number of seniors participated in drug trials.
• Failure to document safety and effectiveness. According to GAO, one-third of new drug reviews failed to include documentation of FDA medical officers’ review of drug safety and effectiveness data for seniors.

Of these, excluding or failing to recruit adequate numbers of seniors for drug trials is the most troubling. Since the clinical trials are the only data that the FDA has to determine whether a drug is safe and effective for the population that will be using it after approval, it is vitally important that the clinical trial participants be a microcosm of the much larger patient population that is likely to use the drug once it’s approved.

We know that some side effects don’t show up in clinical trials, either because of the smaller number of people taking the drug or because some side effects only surface after patients have used the drug for longer periods. The FDA at times requires drug makers to conduct “post-marketing studies” after the drug has been approved — studies designed to ferret out the drug’s true risks and side effects once the “real world” data from millions of uses are available. Yet last year, the Office of the Inspector General issued a report documenting the incredibly shoddy job the FDA does at following up and making sure that drug companies actually do these studies.

The FDA’s failure to ensure that post-marketing studies are conducted makes it all the more important that clinical trials conducted to get the drug approved accurately reflect the patient population that is likely to take the drug once it’s approved. This is doubly important for seniors, who take more drugs, are likelier to suffer side effects, and far likelier to have other, complicating conditions.

Yesterday, Democratic presidential contender John Edwards announced a set of proposals to “Stop Misleading Drug Marketing By Standing Up To Drug Companies.”

We’re glad to see these proposals, not necessarily for their specifics as such (more on that later), but rather for their “diagnosis,” if you will. Edwards is correctly pointing the finger at drug advertising as a major factor in runaway drug spending and inappropriate prescribing. The statement on his website points to the explosion of spending on drug ads since the FDA relaxed the rules for such ads in 1997, reiterates that drug companies spend roughly twice as much on marketing and administration as they do on research and development, and highlights the role that drug ads play in “promoting ineffective and even dangerous drugs” (sing Zelnorm as an example — which we’ve written about here before: Zelnorm: A Case Study in why drug advertising is a bad idea). Finally, he lays a good chunk of the blame were it belongs: On the FDA, for failing to review drug ads in a timely manner, and on the pharmaceutical industry’s massive spending on lobbying and campaign contributions, producing a Congress that lacks the gumption to pass real and significant reform of how drugs are tested, approved, marketed and paid for in the U.S.

Here’s what his campaign website says he proposes to do, and our thoughts on each proposal

Proposal #1:

Delay New Ads to Put Safety First: Often, serious safety issues appear only after a drug has hit the market. Edwards will institute a two-year delay on consumer advertising of all new drugs, as recommended by the Institute of Medicine and the American Medical Association. A delay will ensure that well-informed doctors – not high-paid advertising consultants – drive prescriptions in the early phases before Americans know the full effects of new drugs.

Our thoughts: The “two year moratorium” has been batted around since Merck’s voluntary withdrawal of Vioxx back at the end of 2004. Most recently, this was briefly proposed as a provision in the FDA Amendments Act of 2007 (FDAAA – as in “open wide and say Fdaaaaaaa….”), but taken out, after the industry lobbied heavily against it and made implicit and sometimes explicit threats to sue to block it on the grounds that it would violate drug companies’ free speech rights. PhRMA, the drug industry’s lobbying group, included in its ” Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines” (for which PhRMA received one of PAL’s coveted Bitter Pill Awards, the “The Fox Guarding the Hen House Award : For Pushing Toothless Voluntary Guidelines on Drug Advertising”) a provision calling on signatory companies to:

“spend an appropriate [unspecified] amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign.”

In other words, even PhRMA supported a delay between the introduction of a new drug and when ads begin appearing on TV — but they of course wanted it to be voluntary.

What would such a delay do? Such delays are premised on the idea that the reality of new drugs — side effects, risks, etc — doesn’t become clear until several years after the drug has been on the market. The clinical trials which drug companies submit to the FDA test the drug on, at most, a few thousand people. Unusual risks and side effects, or those that show up only after prolonged use, either don’t show up in those trials or fly below the radar. Supporters of drug ad moratoria presume that more of those longer-term or rarer side effects and risks will be apparent after the moratorium ends, than if drug ads started right away. That is likely true, although two years may not be enough. If drug ads are delayed, patients won’t be seeing ads on TV for a brand-spanking-new drug the week it comes on the market and thus not crowding their doctors’ offices demanding a prescription. The notion is that doctors will have two years to come to a calm, independent conclusion about the drug — and then they’ll be better prepared to deal with patients’ demands for the Wonder Drug they just saw on TV.

But this presumes too much. What will be happening in those two years? Those legendary perky young attractive drug salespeople will be descending on doctors’ offices to preach about the wonders of the new drug to doctors. Medical journal articles written or ghostwritten by doctors on the take from the drug company will appear, lauding the new drug. “Thought leaders,” physicians identified by the company as particularly influential, will get paid to be “guest speakers” at conferences and dinners to talk about how great the drug is.

In other words, the same thing that goes on now in doctors’ offices will continue to go on, skewing doctors’ impressions of new drugs, and convincing them to prescribe them to their patients, even if it’s more expensive and no better. There’s nothing to guarantee that a doctor will to a more independent or more thoughtful conclusion about a new drug just because there was no ad on TV in the first two years.

While it’s true that evidence about side effects and risks, and about the drug’s true effectiveness, may come to light in the intervening two years, such a delay in and of itself will not do much to change the landscape of drug advertising. A drug can be hyped through clever ads whether it’s been on the market for a day or a decade. A delay presumes too much by concluding that ads for drugs have any place in our health care system — a conclusion that every other country besides the US and New Zealand has rejected.

Proposal #2:

Get Control with Real Oversight of Advertising: Edwards will give the Food and Drug Administration real power to prevent misleading drug ads by requiring the agency’s approval before drug companies can launch major ad campaigns. He will also increase the penalties for drug companies that violate truth-in-advertising laws.

The aforementioned FDA Amendments Act of 2007 gave the FDA for the first time the power to charge fees for drug companies that submit their drug ads for “pre-broadcast approval.” However, it didn’t go so far as to require that drug companies submit their ads before they air. As long as submitting ads before broadcast is “voluntary,” drug companies will be able to run ads that violate the FDA’s standards.

The FDAAA also gave the FDA the power to impose fines on drug companies that violate these standards (before, all the FDA could do was send the company a letter asking them to stop running the ad, and usually these letters came months after the ad had stopped running). So even if a drug company doesn’t submit an ad for “pre-broadcast approval,” the FDA theoretically now has the power to do something about it (levy a fine). It remains to be seen whether the FDA actually will ever use this power to levy a fine, and whether it will back down the company that gets fined raises a stink about it. As far as Edwards’ proposal to “increase the penalties,” there’s not enough detail there to comment on it. Except to say that the penalties allowed for under the FDAAA are modest — up to $250,000 for each violative ad, but not exceeding $500,000 for the same company in three years. And the key words here are “up to,” as we’ve said here before.

Proposal #3:

Require “Whole Truth” Disclosures: Edwards will improve drug makers’ disclosures to the public, requiring companies to tell the public the whole truth about side effects and how effective drugs are against placebos and existing alternatives. As a result, drug companies will no longer be able to advertise costly “me-too” drugs without disclosing the existence of less costly alternatives. He will also require drug companies to disclose foreseeable side effects from implants of medical devices, which are not disclosed today.

This gets to one of the main problems with how drugs are evaluated in the United States – the FDA only requires that a drug company show that its new drug is better than a placebo – in other words, better than nothing. There’s no requirement that a drug company test their new drug against other drugs treating the same thing, or that they tell you how their drug stacks up against competitors. It is a system like this that allows a drug like Nexium, which is no better than its predecessor Prilosec, to rack up $4.6 billion in 2006 sales. A huge percentage of new drugs in the past ten years have been so-called “me too” drugs — drugs that treat the same thing in the same way (mechanism of action) as other drugs currently on the market. Most of the time, there’s no meaningful difference between the various drugs. Yet this is the stuff that billion-dollar blockbuster drugs are made of.

It’s not clear from this proposal exactly what Edwards proposes to require. The next proposal offers a little more detail:

Proposal #4:

Help Doctors Make Decisions Based on Evidence, Not Ads: Edwards will establish a non-profit or public organization – possibly within the Institute of Medicine – to research the best methods of providing care, drawing upon data from Medicare and the Health Care Markets and medical experts from across the nation. The center will perform head-to-head testing of drugs, as well as devices, to see which work best for specific conditions and populations. It will quickly and widely disseminate its unbiased, scientific findings to physicians and patients. In addition, the FDA will require drug companies to conduct head-to-head testing prior to approving new drugs.

Head-to-head testing of drugs makes enormous sense and is one the main things missing in our current system. However, we should not be content to leave such testing to the drug companies themselves. Research has shown that studies head-to-head drug studies sponsored by one manufacturer tend to show that manufacturer’s drug in a more positive light (surprise!). Having an independent body do such testing makes sense. This is a central piece of what’s needed to make a shift to what’s being referred to these days as “evidence-based prescribing.”

Having the FDA require head-to-head testing as a condition of approval is intriguing, but again the proposal here is a little short on detail. Does this mean that the FDA would only approve drugs that perform better than others already on the market? Or does it mean that drugs that performed better than a placebo would still be approved, but would have to disclose that they didn’t perform better than other drugs.

In sum, Edwards’ proposals announced today offers some interesting and important ideas, and hopefully will contribute to a more vigorous debate in the presidential race about how to address these issues. Some of these proposals are not fully fleshed out, so fully evaluating them is not possible at this stage. Hopefully, more detailed proposals — from all the candidates — will be forthcoming. With health care continuing to rank second in most voters’ most pressing issues for the presidential candidates to address, and prescription drug costs contributing so significantly to the cost of health care, the candidates need to get specific about how they’ll rein in the worst excesses of the pharmaceutical industry.

Readers of this blog have previously read about a lawsuit brought by PAL member Service Employees International Union (SEIU) Health and Welfare Fund against Abbott Laboratories (NYSE:ABT), charging that Abbott’s unconscionable 400+% price increase of the vital anti-HIV/AIDS drug Norvir violated antitrust laws.

That lawsuit has withstood various attempts by Abbott to have it dismissed– defeating a motion to dismiss, defeating a motion for summary judgment, being certified as a national class action, and then surviving an Abbott challenge to that class action status. The trial is scheduled to begin next summer.

Now the chain supermarkets are joining in. The Wall Street Journal reported yesterday that Safeway Inc., Walgreen Co., Kroger Co., Supervalu Inc.’s New Albertson’s Inc. and American Sales Co. have filed a similar lawsuit. It’s not clear from the WSJ article what exactly the supermarkets are claiming, or how they allege they have been damaged. If a copy of the complaint comes our way, we’ll update this entry.

Abbott announced the price increase back in December 2003. What took these supermarkets so long? It’s almost 3 years later. The filing of the suit now may have been motivated by the fact that various states have 3 year statutes of limitations (the amount of time you can file a lawsuit after an alleged “wrong” has occurred) for various kinds of claims concerning alleged fraud. Three years would be up in this instance in about a month. These supermarkets may also have seen the progress of the SEIU suit and concluded that they have a viable case as well.

Merrill Goozner, of GoozNews, (and author of the $800 Million Pill, which contains a chronicling of the development of Norvir), dryly noted “If we had a government (and a Justice Department) that cared about consumer protection, it would join in these suits by invoking the government’s right to ensure that the drug is made available on reasonable terms.”

The last phrase in that quotation refers to the fact that Norvir was developed in part with public funds. Under the Bayh-Dole Act, inventions developed with government funds must be made available to the public on reasonable terms. In 2004, the consumer group Essential Inventions petitioned the FDA and NIH to force the licensing of a generic (a move provided for by the Bayh-Dole Act) because Abbott was not making Norvir available on reasonable terms. In a move notable for its lack of surprise, the FDA and NIH declined.

Even we prescription drug policy geeks here at PAL have to take a break occasionally…

And we’re located in Boston, so we have to give props to our Hometown Team, who last night won Game 2 in the World Series, against the Colorado Rockies.

Go Sox!

Let the Red Sox remind us all that an underdog once woken is a force to be reckoned with…

Courtesy of the indefatigable Peter Rost at BrandweekNRx:

So this week I participated in a hearing in the Swedish Parliament on more effective use of pharmaceuticals.

Anders_lif_23I wasn’t the only one presenting, Anders Blanck, the deputy CEO of LIF/PhRMA (the Swedish pharmaceutical industry organization) also spoke for a short while.

He’s probably the only PhRMA executive in the world with long stylish hair and a pony tail, but hey, I thought he was cute and this is Sweden, after all.

What he said was, however, more important than his hair.

He strongly stated that “Direct to consumer advertising of pharmaceuticals is not something we like or support.”

I couldn’t help myself, so I stood up and suggested that if he’d said that in the U.S. he’d been fired. He didn’t want to comment on that.

And clearly, what is good and bad in pharma-land, simply depends on what you can get away with.

We could use a few American pharma executives to break with the PhRMA party line and admit that Direct-to-Consumer Advertising is Not a Good Thing.

Speaking of Lunesta (see yesterday’s Most memorable drug ads — but what do viewers remember?), here’s a very funny parody of the ubiquitous Lunesta “luna moth” ads (yes, it’s not a butterfly, it’s a luna moth). I believe this is from Saturday Night Live.

Hat Tip: BrandweekNRx

PAL offers its hearty congratulations to the United Federation of Teachers and to the UFT Welfare Fund (the latter a member of the PAL coalition). 28,000 New York City home-based child care providers overwhelmingly voted to form a union with the United Federation of Teachers as their collective bargaining agent. The organizing drive was New York’s largest in decades, and was the result of an unprecedented collaboration between a union (UFT) and a community organization (ACORN).

As union members, these 28,000 child care workers will now to be able to negotiate for better wages and benefits (including, of course, health care). Child care workers usually receive incredibly low pay for work that is absolutely vital to the health, well-being, development and education of millions of children. High-quality child care from trained providers makes an enormous difference in children’s long-term development and educational success. Having a safe and nurturing place to send their children enables millions of parents to go to work. Yet child care workers often struggle to provide for their own families and often have no health coverage. How our society treats child care workers is a sad commentary on how we have failed to provide this essential profession the respect it deserves.

We welcome these 28,000 child care workers to the PAL coalition, through their benefit fund, UFT Welfare Fund. Their victory is a victory for them, their families, the Labor movement, and children everywhere.

Here is the UFT’s press release:

Home child care providers give resounding “yes!” to UFT

Oct 24, 2007 2:00 PM

Providers celebrate the victory at UFT headquarters

Culminating the city’s largest labor organizing drive in decades, New York City’s 28,000 home-based child care providers have voted overwhelmingly to form a union with the United Federation of Teachers as their collective bargaining agent, UFT President Randi Weingarten announced today.

According to the New York State Employment Relations Board (SERB), which tallied secret ballot cards mailed in between September 5 and October 15, the providers voted 8,382 to 96 to form a union that will be represented in contract talks by the UFT, which represents the city’s 110,000 public school educators.

“This vote caps a two-year drive to secure an economic and political voice for home child care providers,” Weingarten said, adding, “The UFT will soon begin negotiations for them and will seek the economic dignity and professional opportunities and respect they so deeply deserve but now lack.

“It is a privilege for the UFT to represent these hard-working providers,” she continued. “They share a bond with teachers in that they help educate and care for thousands of our city’s youngest children. We are grateful for this vote of confidence and we are committed to fighting for their interests and the interests of the kids they serve and integrating the providers into our union family.

“We and our affiliates at New York State United Teachers and the American Federation of Teachers want to help these providers help children make the transition to pre-kindergarten and kindergarten by ramping up what we started, giving the providers opportunities for professional development as well as access to curricula and training. The unionization and professionalizing of providers will give thousands of children who will enter our public school system the head start they need,” Weingarten said.

“We are thrilled that the providers have taken this ultimate step toward obtaining the compensation, dignity and respect they deserve,” said Bertha Lewis, executive director of the New York Association of Community Organizations for Reform Now (ACORN), which worked hand-in-hand with the UFT on a two-year grass-roots campaign to organize the providers.

“This is one of the first genuine collaborations between a community organization and a major labor union, and the result is important for both,” Lewis continued. “Today we celebrate a major accomplishment that bodes well for all workers striving to become part of the middle class in New York City. This partnership between ACORN and the UFT shows that great things can be accomplished when progressive labor groups and community organizations work together.”

“Today marks a great victory for the over 28,000 providers who have joined the UFT, and I thank Randi Weingarten and ACORN for all their work these last few years to make this a reality,” said City Council Speaker Christine Quinn. “In voting to be represented by the UFT, these hard-working New Yorkers have cast a vote for a living wage, for quality health care, for the ability to retire with a pension,” she continued. “This is also a victory for New York City families whose children will now benefit from providers who have access to professional development, curriculum and training.”

Weingarten noted that the providers are among the lowest-paid workers in the region. A 2006 ACORN study showed that the average annual wage for family and group family providers in New York City is $19,933. The federal poverty line for a family of four in 2004 was $18,850. The providers have no health benefits, pension plan or paid vacations.

Luz Alvarez, a 53-year-old native New Yorker who provides care for children in her Manhattan home, said, “Thank Heaven we finally have a union. I’ve been a provider for eight years and in that time I’ve had one vacation, which was to attend my daughter’s wedding. The union can help us go in and negotiate a salary and other benefits so we can take a vacation once a year or take a sick day without losing pay.”

Weingarten said anything the UFT can do to improve services and working conditions for the providers will result in huge, long-term benefits for the children they care for. She cited the Perry Pre-School Study in Michigan, which tracked children from the ages of 3 or 4, when they began pre-school, into their 20s. The study participants had increased cognitive skills and higher academic achievement, improved graduation rates, more college enrollments and greater rates of employment. That study also estimated a savings of $7 for every dollar invested in early education through reduced special education needs, lower incarceration rates and reduced welfare and unemployment costs.

Weingarten thanked and congratulated ACORN and those who spearheaded the union-organizing effort, including UFT Vice President Michelle Bodden, Special Assistant to the President, Amina Rachman, special coordinator Fran Streich and several providers who merited special recognition for their contributions including Tammie Miller, Melvina Vandross, Nila Edwards, Shirley Middleton, Adele Kearny, Cheryl Ipperson, Gladys Jones, Jenni Rivera, Lourdes Lebron and Andrea Royal.

“Our providers did a lot of hard work over the past two years going door to door to enlist the support of their colleagues, getting cards signed, holding house meetings, attending rallies, writing letters, lobbying elected officials and making phone calls. They have done a real service for their brothers and sisters in the cause,” Weingarten said.

Weingarten also thanked key elected officials for supporting the organizing effort including Gov. Eliot Spitzer, Senate Majority Leader Joseph Bruno, Assembly Speaker Sheldon Silver and Assemblyman Adriano Espaillat who had introduced legislation in the state Legislature to allow the providers to organize. Espaillat’s bill was approved by the Legislature but Gov. George Pataki vetoed it. Gov. Spitzer later approved the measure as an executive order.

Weingarten went on to thank state Senate Minority Leader Malcolm Smith, state Senator Bill Perkins, former state senators Carl Andrews and Nick Spano, City Council Speaker Quinn and City Council members Bill de Blasio, Robert Jackson and Joel Rivera for supporting the organizing effort.

“It took a lot of hard work by a lot of people to get to this point, and there’s still much more work ahead of us,” said Bodden, who helped coordinate the union organizing effort. “But even so, we should take a moment to savor this victory and congratulate the providers for taking this bold step toward their empowerment.”

“Today the voices of thousands of city day-care providers have been heard,” said Richard Iannuzzi, president of New York State United Teachers, the UFT’s statewide affiliate. “These new union members join forces statewide with more than half a million NYSUT members who work in education and health care. As unionists, their voices will be amplified as together we seek the pay and respect that recognizes the important work they do.”

Nat LaCour, secretary treasurer of the American Federation of Teachers, the UFT’s national affiliate, said the inclusion of the providers in the AFT marks the largest addition of workers unaffiliated with any other union or organization in the AFT’s history.

“There is an old saying in early childhood education: ‘Parents can’t afford to pay, workers can’t afford to stay, there’s got to be a better way.’ Today I believe that the UFT and ACORN have created that elusive better way,” LaCour said. “Together they have blazed a trail for a new form of community-focused union organizing that recognizes child care workers’ right to fair wages, children’s right to the best early learning experiences possible, and parents’ right to affordable and readily available, high-quality care.”

Following the vote count, several of the providers said they are thrilled to be part of a union with the ability to fight for a better way of life for them and their colleagues as well as better conditions for the children they serve.

“I’ve been doing this for four years now, and I couldn’t be happier about this vote because what the UFT will be able to do for us will improve the lives of thousands of children throughout New York City,” said Tammie Miller, a 40-year-old native New Yorker and a mother of two children attending city public schools who cares for children in her home in the Kensington section of Brooklyn.

“We are the children’s first teachers, so we represent hope in their lives just as the UFT represents hope in our lives. Without a union, without all this hard work, there was no hope for us,” Miller continued. “We always teach our children that if they work really hard they can be whatever they want. And that’s what we’ve been doing, working hard for two years now for what we want. We are living examples of that. Being in a union was just a dream at one point, and now it’s here.”

The UFT and ACORN already helped the providers by successfully lobbying the city and the state over the summer to pay some of them $160,000 in back pay. The UFT’s Teacher Center also sponsored free classes in childhood development, early preparation for literacy and other subjects for about 3,500 providers.

Weingarten said the next step will involve surveying the 28,000 providers to determine their contract priorities, goals and professional needs before seeking to begin negotiations with the New York State Office of Children and Family Services.

The UFT and ACORN had worked to unionize the providers for about two years in what had been the largest organizing drive in New York City since the UFT became a union in 1960 with 45,000 members.

After counting authorization cards it received from more than 12,000 New York City home day care workers last May, SERB certified that the UFT and ACORN surpassed the margin required for the workers to hold an election to join a union. The cards were filed May 17, less than a week after Governor Eliot Spitzer signed an executive order allowing more than 60,000 providers across the state to organize. Prior to the Governor’s action, the providers could not organize because the state treated them as independent contractors. His executive order effectively made the providers quasi-employees of the state, which permits the UFT to negotiate for them.

Signatures on the authorization cards from 30 percent of the total 28,000 city providers – fewer than 9,000 – were needed to trigger an election. SERB conducted a count of the city providers’ cards between July 12 and July 19 and determined that the margin was surpassed with 8,860 providers voting to hold an election. SERB scheduled the election and the UFT and ACORN embarked on a get-out-the-vote effort involving advertisements in local newspapers, rallies and door-to-door campaigning through the end of August.

SERB tallied the mailed in secret ballot cards yesterday. A simple majority was required for the UFT to become the providers’ collective bargaining representative. As a result of the vote, the UFT now represents the 28,000 providers in New York City. The Civil Service Employees Association is seeking to organize day care providers in the rest of the state.

New York is the eighth state to let home-based providers unionize. They receive government subsidies to watch, care for and educate children from low-income families in pre-school and after-school settings. They provide meals and snacks, help children with reading, learning colors and numbers, help with homework, direct safe play and change diapers.

Yesterday IAG Research released “the latest syndicated data for the most memorable new prescription drug ads launched during the 2006/2007 TV season.”

The results were not surprising — some of the drug ads that many of us love to hate topped the list for “memorability.” What’s galling is that even those of us who hate them have been affected by them.

Not surprisingly, a number of winners of PAL’s coveted Bitter Pill Awards were among those most recalled. Our Bitter Pill Awards particularly seek to call attention to those drug ads that elevate image over substance, or that overpromote expensive brand-name drugs that most people don’t need. Among those deemed most memorable were Lunesta (see its While You Were Sleeping Award here), Lipitor (Got Cholesterol? Award here), Crestor (ditto)and Cialis (Performance Anxiety Award here)

IAG’s press release says:

Whether it is a moth, a talking bee or a dead president and beaver, this season’s ranking of the most memorable new ads is dense with unique icons that have become the cornerstone for successful campaign development in this industry. Icons have taken the shape of human and animal figures as well as symbols such as Vytorin’s “food and family” split screen comparison or Cialis “outdoor tubs”.

“The fact that Lunesta along with other prescription brands including Nasonex, Rozerem and Vytorin remain at the top is a testament to strong campaign development that continues to deliver seamless creative extensions that effectively break-through the clutter and reinforce the brand identity synonymous with the icon present in the ads,” said Ms. Fariba Zamaniyan, Sr. Vice President of IAG Research’s Pharmaceutical Practice.

In other words, the key is to find an eye-catching image that “reinforce[s] the brand identity.” What about whether the drug is effective, or what the side effects are, or how it compares to other treatments? Is this information what constitutes the “clutter?”

IAG measured memorability this way:

The Recall Score is the percentage of TV who can recall within 24 hours the ad and the brand they were exposed to during the normal course of viewing TV. These scores are then indexed against the mean score for all new ads during the period (Recall Index). 100 equals average.”

Noticeably absent is anything about whether the viewers could recall anything important about the drug after 24 hours — like the risks and side effects, and who should not take the drug. It’s safe to say that while people probably remember the Lunesta luna moth, they probably don’t remember “In rare cases, severe allergic reactions can occur. Most sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Side effects may include unpleasant taste, headache, drowsiness and dizziness.”

Here’s the list for most recalled ads, courtesy of IAG:

Rank	Brand	Company	Ad Description	Recall Index
1	Lunesta	Sepracor	7-Night Challenge; luna moth flies over bridge and water and into people’s homes/tents. (:60)	157
2	Lunesta	Sepracor	7-Night Challenge; luna moth flies over a lake into couple’s home, then onto woman’s pillow. (:60)	155
3	Zyrtec	Pfizer	Story #43; clothes falls on woman and she sneezes. (:45)	140
4	Nasonex	Schering-Plough	Animated bee talks about prevention of nasal allergy symptoms while buzzing next to Nasonex bottle. (:30)	138
5	Rozerem	Takeda	Abraham Lincoln, talking beaver, man in suit and man in diving suit at a bus stop; your dreams miss you. (:60)	136
6	Lipitor	Pfizer	Dr. Robert Jarvik in white lab coat discusses risk of heart disease and stroke caused by high cholesterol. (:60)	126
	Crestor	AstraZeneca	Man at fish market near ocean whose cholesterol is out of wack; his body splits into various sections. (:60)	126
	Vytorin	Merck/Schering-Plough	Plates of food shown next to shots of relatives such as Grandpa Bow and bowtie pasta. (:60)	126
7	Valtrex	GlaxoSmithKline	Couple talks about the risks of contracting herpes; 70% of people affected got it from their partner. (:60)	124
	Cialis	Eli Lilly	Couples in various romantic places including laying in front of fireplace, in restaurant, in rowboat and laying on hammock. (:60)	124
8	Gardasil	Merck	Young women including a cowgirl, colorguard, gymnast and softball player say they want to be “One Less” (:60)	120
	Caduet	Pfizer	Woman in red vest walks along a beach; splits into two and says she has high blood pressure & cholesterol. (:60)	120

Hat tip: The irrepressible Pharmalot

The Association of Community-Affiliated Plans, a member of the PAL coalition, released a study yesterday showing that Medicaid managed care health plans that manage their members prescriptions have higher rates of generic usage and better coordination of patient care than Medicaid managed care plans that do not.

Many states encourage Medicaid recipients to enroll in “Medicaid Managed Care Organizations (MCOs),” private health plans that contract with the state. Some states include prescription drugs in the package of services that Medicaid MCOs deliver (so-called “carve-ins”) while other states specifically exclude prescription drugs, which the state then pays for and manages itself (so-called “carve-outs.”) One reason that some states “carve out” the pharmacy benefit is that Medicaid MCOs are not eligible to receive the Federal rebate that states receive for Medicaid prescription drug costs. ACAP says that allowing Medicaid MCOs to receive that rebate would save an additional 20% on drug costs. ACAP is supporting bills currently before Congress which would make Medicaid MCOs eligible for the rebate.

Here’s ACAP’s press release:

For Immediate Release
October 24, 2007

Pharmacy Carve-In Arrangements for Medicaid Managed Care Promote Better Health and Savings

Washington, DC – A study released today by the Association for Community Affiliated Plans (ACAP) finds that Medicaid managed care programs operate more effectively and thus improve patient care and cost-savings when prescription drugs are included within managed care arrangements rather than “carved out.” (“Carved out” means that the drug benefit is not provided by Medicaid health plans in the Medicaid managed care program.) The report, written by The Lewin Group and called Programmatic Assessment of Carve-In and Carve-Out Arrangements for Medicaid Prescription Drugs, is released as a proposal is pending before Congress that would protect “carve-in” arrangements by allowing Medicaid health plans to have access to the Federal drug rebate—a proposal that the Congressional Budget Office predicts will save the Federal Government over $2 billion over the next ten years.

“We engaged Lewin to assess the programmatic issues involved in including pharmacy benefits and the potential impact on both the quality and coordination of patient care,” said Margaret Murray, Chief Executive Officer of ACAP, which funded the study. She added, “We were interested in hearing from and interviewing a variety of key stakeholders, including Medical and Pharmacy Directors from managed care organizations in both carve-in and carve-out state Medicaid environments, as well as others who could provide insight into the state Medicaid agency, provider, and pharmacy perspectives.”

Some of the study’s specific findings include:

• Carve-in arrangements can improve patient care because pharmaceutical and other medical benefits are managed by one entity, allowing for faster and more efficient communication. Carve-ins also generate incentives to address the “total person” effectively from both a clinical and cost perspective.
• Carve-in health plans rely more heavily on generic drugs to achieve pharmacy cost savings. As of 2006, 75% of health plan prescriptions were filled using generic products, whereas in Medicaid carve-out settings generic fill rates range from 55% to 63%.
• Medicaid health plans managing pharmacy benefits have the capability to access in-house pharmacy and medical claims data in real time, which is a critical tool in promoting improved health outcomes, tracking prescriptions among multiple pharmacies, and positively influencing physician prescribing patterns to identify quality and cost issues.
• Pharmacy carve-in arrangements allow health plans a unique opportunity to closely monitor all prescription drugs that patients take to safeguard against dangerous drug interactions, drug abuse, and to effectively address the needs of the chronically ill.
• Pharmacy carve-ins also alleviate a range of operational challenges as Medicaid recipients, providers, health plans and states no longer need to sort through how various parts of the benefits package are administered. Health plan enrollees in a carve-out model, for example, typically need to carry multiple health insurance cards and to keep track of which card is needed for a given type of service.

“To ensure the greatest possible coordination of our enrollees’ health care, the pharmacy benefit must be included with all other physical and mental health services,” said Pamela B. Morris, CEO of CareSource in Dayton, Ohio. “Medicaid health plans want to treat the entire individual to provide better quality health care, and since pharmacy is a critical part of medical treatment, it should always be carved-in.”
In regard to providing better opportunities for care coordination and the management of patients’ costs and care, Joel Menges, a Lewin Vice President and principal author of the study, noted that “the optimal financial situation, by far, is to combine the health plans’ benefit management expertise with the rebates that currently can be accessed only in the FFS Medicaid setting. A change in Federal policy allowing Medicaid health plans the same rebates for Medicaid prescriptions as Medicaid FFS receives would likely yield more than a 20% savings in net pharmacy costs for Medicaid managed care enrollees.”

Such a policy change has been included in two pieces of currently proposed Federal legislation – Senate Bill #1589 (sponsored by U.S. Senator Jeff Bingaman (D-NM) and House Bill #3041 (sponsored by U.S. Representative Bart Stupak (D-MI)). The Congressional Budget Office has scored such a proposal as saving the Federal Government $2.3 billion over ten years.

An electronic copy of the study is available at: www.lewin.com and www.communityplans.net.

For further information, please contact:

Joel Menges, Vice President, The Lewin Group: (703) 269-5598

Margaret Murray, Executive Director, ACAP, (202) 331-4601

Associated Press reports today “Drugmaker says 2 million starter kits of weight loss pill sold since June”.

We here at the PAL Blog have been reporting on alli’s brisk sales ever since we have GlaxoSmithKline one of our Bitter Pill Awards back in May, the “With Allies Like This, Who Needs Enemas?” Award. Our posts since then about alli can be found here.

The AP article reports that GSK “expects to sell between 5 million and 6 million kits annually, translating to at least $1.5 billion (€1.06 billion) in annual retail sales.” Drugs with more than a billion in annual sales are considered “blockbusters,” but they’re usually limited to prescription drugs. This shows the success of GlaxoSmithKline’s strategy, in marketing alli (orlistat) as an over-the-counter drug, rather than as a prescription-only drug, which it used to be. The prescription version, Xenical, had only $86.6 million in sales in 2005, according to IMS Health. Yet the drug is no different, except for the dosage. The only difference is that by making it Over-the-Counter, Glaxo has done an end run around physicians, who never considered the drug very useful, as demonstrated by its lackluster sales.

To rephrase an old saying, “No one ever went broke underestimating the American people’s desire for a quick fix.” GlaxoSmithKline certainly isn’t – notwithstanding alli’s well-publicized side effects — including leakage, oily discharge and fecal urgency. Which GSK euphemistically calls “treatment effects.” And convinces people to shell out $50-60 a month for the privilege of experiencing.

Truth is indeed stranger than fiction.