September 03, 2008

The Pied Piper Effect

by Peter Pitts

A new study out of Harvard debunks the canard that DTC advertising causes a “Pied Piper” effect of patients marching en masse to their physicians demanding drugs they don’t need.

Reuters reports that, “Expensive advertising of prescription drugs directly to consumers may do little to encourage sales, U.S. and Canadian researchers reported on Monday.”

According to the report, even though companies spent an estimated $3 billion in 2005 on such ads in the United States, they did not appear to result in more prescriptions.

"People tend to think that if direct-to-consumer advertising wasn't effective, pharma wouldn't be doing it," HarvardMedicalSchool's Stephen Soumerai said in a statement. "But as it turns out, decisions to market directly to consumers are based on scant data."

The nonprofit Kaiser Family Foundation has come to similar conclusions in reports on direct-to-consumer ads.

In an April report the foundation found that 91 percent of adults surveyed had seen or heard advertisements for prescription drugs, but just one-third spoke to a doctor about a drug they saw advertised, and 54 percent of them got a prescription for a different drug.

Among doctors, 76 percent said they sometimes recommend a different prescription drug to a patient who mentions a drug ad and 5 percent said they frequently gave patients the drug.

Posted by peterpitts at 07:49 AM
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August 28, 2008

How does a Scotsman get his healthcare information?

by Peter Pitts

How does a Scotsman get his healthcare information? With difficulty.

Here's a new article from The Scotsman:

Advertising rules stifle free market for prescriptions
By Peter Pitts

IN EUROPE, it is illegal for drug companies to advertise prescription-only drugs to consumers. But the European Commission (EC) recently announced that it will allow pharmaceutical firms to disseminate "information" on their products over the airwaves, on the internet, and in print.

I think this change can't come soon enough. For too long, European bureaucrats have put cost considerations before patient care, keeping patients in the dark about alternatives that may best address their needs. Officials have, I think, paid lip service to the idea of empowering patients with more information on treatment options.

James Copping, a principal administrator of the EC, said in 2006: "We want a system where patients can be empowered to take an equal part in healthcare decisions." But thus far, no such thing has happened.

Consider the European agencies tasked with weighing the effectiveness of various treatments, such as the UK's National Institute for Clinical Excellence (Nice) or Germany's IQWiG. These agencies exist to provide unbiased medical information to government.

But because they are operated by government, I would say they have a vested interest in keeping costs down and have an incentive to conclude that newer, more expensive medicines are no more effective than older, cheaper ones.

Nice offers an instructive example. In 2001, contrary to expert findings by licensing authorities in 65 countries – including Scotland – it cited "insufficient evidence" for recommending the use of Gleevec in leukaemia patients.

In 2002, US authorities approved Gleevec for the treatment of stomach cancer and it was deemed a miracle drug. It wasn't until 21 months later that Nice authorised the use of Gleevec for English victims of the disease.

IQWiG seems similarly set on depriving German patients of vital treatments. The agency has promoted an "efficiency frontier" as its governing methodology for evaluating treatments. But such jargon is smoke and mirrors, designed to cover for the government's preference for established – and generally less expensive – treatments, and by decreeing the most cost-effective option in a treatment category, these agencies effectively determine what a doctor must prescribe, irrespective of a patient's individual characteristics.

Obviously, pharmaceutical companies have products to sell. But, by allowing them to provide Europeans with medical information, they could serve as a counterbalance to the heavy-handed pronunciations of state-run comparative-effectiveness agencies.

Indeed, a great deal of evidence demonstrates that consumers benefit when drug manufacturers participate in healthcare decision-making.

In the US, for example, a 2002 study by the Food and Drug Administration found that direct-to-consumer advertising of pharmaceuticals improved both patient-doctor discussions and compliance with physician recommendations. The study also found that 88 per cent of patients who asked about a specific drug were afflicted with the condition in question.

A 2003 study in US health policy journal Health Affairs arrived at a similar conclusion. According to the study, ad- inspired doctor visits resulted in the advertised medicine being prescribed in only about 47 per cent of cases. Put another way, patients didn't get a prescription for the medicine they came in to discuss on more than half their visits. Even with advertising, doctors exert appropriate judgment when they prescribe drugs.

On other occasions, according to the study, previously undiagnosed medical conditions get treated – a good thing.

For European bureaucrats, there is reason for concern. If consumers can get additional information on drug options thanks to direct-to-consumer efforts, there's a good chance they'll start to ask the state-run health systems why they can't access certain treatments.

As European Parliament member Jorgo Chatzimarkakis recently argued: "Citizens cannot be deprived of information by their own governments on such crucial issues as one's health."

Government-run systems have demonstrated that they're not interested in spending more money, but armed with new information, consumers may be able to make the case to their leaders that the status quo of rationed, controlled care will no longer suffice.

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June 23, 2008

Must see TV, eh?

by Peter Pitts

According to PharmaTimes, CanWest Mediaworks, Canada’s largest newspaper publisher and owner of more than 30 television stations, is suing the federal government for not permitting direct-to-consumer advertising of prescription drugs because, it says, this breaches its freedom of expression under Canada’s Charter of Rights and Freedoms.

CanWest is arguing in the Ontario Superior Court that this prohibition, which is part of the Canadian Food and Drugs Act, places it at a competitive disadvantage to US newspaper and magazines which are sold on Canadian newsstands, because it prevents it from selling advertising space to pharmaceutical manufacturers. The company also points out that Canada does allow OTC medicines to be advertised directly to consumers, even though these products also carry risks.

The case will be heard this month.

Posted by peterpitts at 08:18 AM
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June 16, 2008

Stipulating Bias

by Peter Pitts

According to a new editorial in the Lancet, “From February to April this year, the European Commission (EC) held a public consultation on proposed legal changes that would allow pharmaceutical companies to provide information to patients about prescription-only drugs via all available media. The Commission's proposal states that the ban on direct-to-consumer advertising (DTCA) in Europe would remain. However, many critics rightly feel that allowing the industry to provide information to patients is effectively DTCA under a different name.”

Who are these critics? What are the agendas? Where does their funding come from? On these questions the Lancet is silent.

The Lancet opines, “Patients' access to quality information is variable across the European Union's 27 member states and the Commission is right to want to address this inequality. But the pharmaceutical industry's obvious financial conflicts of interest mean that drug information provided by them is likely to be prone to bias.”

“Likely to be biased?” On what do they base this rather strong statement? Isn’t solid, unbiased information in the best interests of both sales and the public health? Isn’t there a more inherent “bias” by having payers control what information consumers get to see? And in the EU, “payers” = “government.”

The editorial concludes, “Patients have a fundamental right to access good quality, objective information on medicines. The EC's final proposal, due out later this year, must empower patients and not the drug industry.”

Why not empower the drug industry to empower patients? That’s what the pending EC directive is all about.

And as far as the Lancet stipulating bias, consider the words of Robert Benchley:

"Tell us your phobias, and we will tell you what you are afraid of."

Posted by peterpitts at 08:20 AM
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May 30, 2008

Old News is Good News

by Peter Pitts

Samuel Johnson said that “the future is purchased by the present.” And that’s as good a place to start as any in a discussion of the impact of direct-to-consumer advertising on the elderly.

According to recent polls, older Americans are more distrustful of the pharma industry and the FDA than the general population—and even more so in the wake of the current debate over drug safety.

Seniors want safe drugs—and rightfully so—but why are they more negative than other groups of Americans? I believe it is because throughout the significant majority of their lives, their only information about the medications they took came from a single source—their doctors. And the only information offered was how to imbibe the pill (with water, with food, minus alcohol, and the occasional caveat against operating heavy machinery). There was no doctor/patient discussion and there was certainly no public conversation.

That was the environment in which today’s senior citizens were born, grew into adulthood, married, raised children and grew grayer.

It was an environment where doctors were gatekeepers and the gate was kept tightly padlocked and second opinions were considered an affront to Marcus Welby, MD.

According to Juvenal, “All wish to possess knowledge, but few, comparatively speaking, are willing to pay the price.” Today we must face up to that dilemma.

Like it or not, America’s senior citizens are 21st century empowered healthcare consumers. Today, the “learned intermediary” has been replaced by the Internet, the patient is the purchaser, and Dr. Welby is a vendor. Managed care directs, “serious and life-threatening” diseases have morphed from polio and diphtheria to cancer, AIDS and Alzheimer’s Disease. There really shouldn’t be any wonder why older Americans—indeed, most Americans—are frightened. The entire healthcare paradigm has changed.

Woody Allen said that “Change is inevitable – except from vending machines. Management guru W. Edwards Deming said that “Change is not required. Survival is not mandatory.”

Change is frightening. In the 21st century, we must all be pharmacenti. And that includes older Americans.

The Centers for Disease Control and Prevention National Health and Nutrition Examination Survey found that nearly one-third of people age 65 or older whom the survey found to have high cholesterol measurements said they had not before been told by a physician or other health professional that they had high cholesterol. Projected nationally, this percentage translates into about 2.1 million people who may have had high cholesterol without knowing it.”

Evidence is emerging that large numbers of elderly patients underuse needed medical care. According to a 2004 Health Affairs study that examined the “growing philosophical conflict over the abundance and inequities that characterize the U.S. health care system,” there is evidence of significant underuse of prescription drugs. The preponderance of published medical literature and clinical guidelines, according to the article, compels the expansion of pharmaceutical use among Americans.

This view is supported by a landmark RAND Health study published in The New England Journal of Medicine in June 2003, which found that prescription medications were underused in the treatment of seven conditions that clearly involve secondary prevention, including asthma, cerebro-vascular disease, congestive heart failure, diabetes, hypertension, and high cholesterol. These conditions produce many avoidable deaths, along with costly avoidable emergency room visits, hospitalizations, and nursing home admissions. Three of these conditions— diabetes, hypertension, and high cholesterol are now screened for under the new preventive services benefits now covered by Medicare.

Healthcare education and health literacy for older Americans is essential for both saving lives and saving our health care system. And the best way to do both is to get older Americans to talk with their doctors – precisely the proven result of pharmaceutical direct-to-consumer advertising.

Health care information is the consumer’s Rosetta Stone – but older Americans shouldn’t need a Rosetta Stone to understand the avalanche of health care information that is available to them today.

Dr. Ruth Day of Duke University speaks about the issue of “Cognitive inaccessibility” -- that health care information is disseminated in a way that is not only not understood by consumers but, worse, is misunderstood leading to unintended consequences. She reckons that only 20% of the information put out by FDA is properly comprehended. Her suggestion (among others) is that FDA initially focus on communicating better with health care providers.

When it comes to DTC advertising there is another type of cognitive issue – cognitive dissonance, specifically when it comes to information presented either via fair balance and adequate provision in television commercials, or the brief summary in print advertising. And you know what they say, the brief summary is like the Holy Roman Empire – it is neither brief nor a summary.

In FDA’s 1999 study, 56% of people who saw a DTC print ad said that they read the brief summary “not at all” or “a little.” In the 2002 study that number jumped to 73% -- a 17% increase. During that same three-year span, those saying they read “Almost all” or “All” fell from 26% to 16%.

In 1999 3% said they weren’t aware that there even was a brief summary. In 2002, that dropped a full decimal place to 0.3%. In other words, more people know the brief summary is there, and fewer people are reading it. More information often results in less comprehension and, even worse, less interest. When it comes to older Americans this is a crucial issue that must be addressed by academics, the pharmaceutical industry, and the FDA. “In compliance” and “user-friendly” must not be mutually exclusive terms for anyone – least of all older Americans.

Consider the question posed by T.S. Eliot who asked,

"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information?”

Posted by peterpitts at 01:12 PM
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April 25, 2008

EU Considers Merging onto the Healthcare Information Superhighway

by Peter Pitts

Maybe it has something to do with the strength of the Euro -- or maybe it has something to do with a patient's right to know. And just maybe things are beginning to change.

Have a look at this new article (from the Journal of Life Sciences) on how the EU is pondering changing what's allowable vis-a-vis what they call "Information to Patients" and we in the US call "Direct to Consumer Communications:

http://www.tjols.com/article-640.html

Bottom line -- knowledge is power.

Posted by peterpitts at 08:30 AM
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March 10, 2008

Verifiably Inane

by Peter Pitts

What constitutes a "complete and reviewable" submission for DDMAC review of a DTC ad?

For a complete answer, see here.

And for an insight into regulatory creep, consider this little codicil:

"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."

This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.

After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.

Verifiable? How about verifiably inane

Posted by peterpitts at 07:08 AM
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February 28, 2008

Tips for savvy medical Web surfing

by Kelly G. Dencker

Below is a helpful piece from CNN on tips for finding credible health information on the Web. The one tip missing here, and in similar other stories like this, is to round out research by going to pharmaceutical company Web sites.

In this era of the new "e-patient" there is an increasing need and opportunity for pharma companies - who employ some of the world's top health experts and field cutting-edge research in their respective product areas - to do more as experts in this space.

Some companies are doing this better than others, but the emergence of the empowered and Web savvy patient should prompt companies, at a minimum, to look closely at their Web site content to determine if they are providing patient/consumer education that measures up to their vast expertise.

Tips for savvy medical Web surfing

By Elizabeth Cohen
CNN

Empowered Patient, a regular feature from CNN Medical News correspondent Elizabeth Cohen, helps put you in the driver's seat when it comes to health care.

ATLANTA, Georgia (CNN) -- When Mary Ryan's 4-year-old nephew, Nick, landed in the hospital with a serious infection, her brother called her in a panic. Ryan isn't a doctor. She's not a nurse. She's a librarian.

Finding accurate, reliable medical information on the Web can be a daunting task.

Nick had cat scratch fever, and for weeks it was impervious to antibiotics. Desperate, the doctor in Nick's small town wanted to use a more powerful antibiotic that might save him -- but also might make Nick deaf.

Ryan's brother hoped she could find something -- anything -- that would save his son without disabling him. Ryan asked one of her colleagues, a research specialist at the Texas Medical Center Library in Houston, to search the medical literature. She came up with an article about an antibiotic that worked against cat scratch fever but wasn't toxic.

"We sent the doctor the whole article, and when he read it, he said, 'This is great. I hadn't thought of that,' " said Ryan, the president-elect of the Medical Library Association. Nick took the antibiotic and recovered without complications.

So if you're trying to find medical information for yourself or someone you love, and you're not lucky enough to have access to a professional research librarian, what do you do?

"The Empowered Patient" assumes you already know the basics of good Internet searching: .gov and .edu sites are to be trusted, as are sites for major health centers (think MayoClinic.com) and health organizations (such as the American Cancer Society's cancer.org).

"But there's so much more you can do. You can take this to a whole new level," says Jan Guthrie, director of The Health Resource, a for-pay medical research service.

So for the Internet searcher hungry for more, here are some tips for being a sophisticated surfer:

1. Use search engines that screen out the garbage for you

There's a lot of junk on the Internet. "It's the wild, wild West out there," says Alan Spielman, CEO of URAC, a company that certifies health Web sites. "You really have to be alert as you go through these sites."

To get rid of the junk, use a search engine that looks only at reputable sites that have been vetted by health professionals. Dirline, run by the National Library of Medicine, is one such engine, as are medlineplus.gov and Imedix.com. Healthfinder.gov searches for information on government health Web sites.

2. Find smart bloggers with your disease

Some bloggers do an excellent job of linking to resources specific to your disease. That goes for advocacy groups, too.

3. Invest 30 minutes in the pubmed.gov tutorial

Pubmed.gov searches the medical literature, but it isn't completely intuitive. It's worth the time to learn how to use it by doing the tutorial.

Nervous you won't understand the technical jargon in medical articles? Don't be, says Guthrie. She advises reading the very beginning of a study and the very end. "The conclusion will tell you whether the treatment they studied was effective, moderately effective, or not at all effective."

In addition, the Medical Library Association, has brochures called Deciphering Medspeak to help translate some of the more common medical jargon.

Tara Parker-Pope, a health columnist for the New York Times, found it useful to specifically search for review articles on pubmed when she was looking for treatments for her mother's esophageal cancer. Review articles give an overview of the latest research on a particular subject. "Review articles are an excellent way to get a lay of the land and to get the big picture on a topic," Parker-Pope says.

To find review articles on pubmed, go to the "limits" tab and then under "type of article", check "review."

4. Click on information about annual meetings

For example, let's say you just got a breast cancer diagnosis. You could go to asco.org, the site for the American Society of Clinical Oncology, and look at information on new breast cancer treatments discussed at last year's meeting.

This is the way to get cutting-edge information, Guthrie says. "Information on new treatments is presented at conferences six to 12 months before it's published in a medical journal."

Guthrie says she managed to find out about a new treatment for tendonitis this way. "It wasn't even in the medical journals yet. We found one doctor in New York who was doing it. If I had tendonitis, it might've been worth traveling to him," she says.

5. When in doubt about a Web site, click on "about us"

Sometimes it's clear who runs a Web site. Often it's not. Clicking on "about us" should explain it. Knowing who's behind the information you're reading (especially if they're trying to sell you something) helps you evaluate whether the information is biased. If you can't figure out who runs the site, don't use it.

And here perhaps are two of the most valuable pieces of advice: Use Internet resources in combination. "An advocacy group or a review article by itself is pretty useless," Parker-Pope says. "No one of these works by itself."

The second piece of advice: Don't expect the Internet to cure your disease. "I wanted to find the needle in the haystack to cure my mother," Parker-Pope says. "But information doesn't cure cancer. It just leads you to the best doctor and the best options."

Parker-Pope never found the needle in the haystack. Her mother, Karen Parker, died nine months after her diagnosis. But because of what they found out on the Internet, Parker-Pope and her family had confidence she received the best possible care. "And feeling confident in your care is no small thing," she says.

Elizabeth Cohen is correspondent with CNN Medical News. Senior producers Jennifer Pifer and Karen Denice contributed to this report.

Posted by kelly_dencker at 08:44 AM
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January 15, 2008

Jonathan Swift, meet Werner van den Gobbledygook

by Peter Pitts

For those of you watching EU policy on information to patients (“ITP” in EU parlance), there are two documents worth discussing.

The first is “Communication from the Commission to the European Parliament and the Council Concerning the Report on Current Practice with Regard to Provisions of Information to Patients on Medicinal Products’

(I know, it sounds like the title of a Jonathan Swift essay)

I quote directly:

“The provision of information on medicinal products requires taking into consideration the needs of patients in the context of healthcare provision.”

Once you get past all the banal bureaucratic gobbledygook, there’s some pretty interesting bureaucratic gobbledygook.

(Is there someone somewhere in a secret, secure location in Brussels named Werner van den Gobbledygook who edits all these EU documents?)

“Most sources available point to the increasingly active role of patients in this regard; patients have a right to be informed and in this context they should be able to access information about their health, medical conditions and the availability of treatments.”

A crucial point – but if the delivery of information is placed in the hands of governments (aka "payors") – will “availability of treatments” be defined as “what will be reimbursed” or will the full panoply of options be presented to newly empowered European patients? This is not just a finesse question, but rather hits at the heart of the matter. He who controls the access to knowledge controls the knowledge.

“Patients are no longer simply taking what is prescribed for them, but are increasingly involved as manager of their health. They become intensely involved with their illness, show great interest in health issues and have a constantly growing need for information.”

This is an elliptical way of saying that, when patients learn that they are being denied treatment because of cost-based vs. patient-centric government care schemes, they get upset – very upset.

And finally, “Recent evidence indicates that patients are however often unsuccessful in playing a larger role in their health decisions.”

Even though government health care limits, by definition, many health care options, the lack of information adds to that dilemma. According to the report, “Although there is insufficient evidence published, an increase in the quality and appropriateness of information available to patients would be expected to contribute to achieve better health conditions and also to contribute to a more efficient use of resources. Better informed patients are expected to adhere better to treatments and to better understand clinical decisions. This should lead in the long term to social and economic benefits.”

That’s right. And, once you plod your way through all the conditional phrasing, the report is saying that more information results in better outcomes which reduces costs. Amen. But when they say there is “insufficient evidence,” what they’re really saying is that there’s actually a lot of solid research – except that it pertains to the positive benefits of direct to consumer advertising. But at least they’ve embraced the concept that more information is better.

Unfortunately the report also calls for the EU to “keep the ban on direct to consumer advertising on prescription-only medicines.” But that's another issue for another time.

Towards the end of the report, this refreshingly honest statement:

“Member States authorities may not be in a position to fully address patients’ needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals throughout the EU.”

So much for Health Action International (HAI) who claims, “There is no health information gap in Europe.”

And then there’s the companion document, “Commission Staff Working Document: Background information supportive to the Communication from the Commission to the European Parliament and the Council concerning the Report on Current Practice with Regard to Provision of Information to Patients on Medicinal Products, in the form of different annexes”

(Indeed, the titles just keep getting sexier, pithier, and more lyrical).

Again, I quote directly:

“Pharmaceutical companies possess key information about their products which only in part (through leaflets and labels) is made available to the public. Consequently, the pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity, and quality of information.”

And, “Like many patient organizations most pharmaceutical companies argue that information should be of high quality and not be judged by its source. These companies want to be able to produce non-promotional information for patients about their own medicines and diseases and make it public.”

EU Commission recognition that the pharmaceutical industry can be a valuable partner in the broader dissemination of timely and accurate health care information is an important step in the right direction.

And it’s about time because, as Julian Morris of the London-based International Policy Network quipped, “Europe is running out of failed alternatives.”

Posted by peterpitts at 10:27 AM
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January 09, 2008

Mad Libs for Legislators

by Peter Pitts

Under the signature of Chairman Dingell and Mr. Stupak, the Energy and Commerce Committee is charging that Dr. Robert Jarvick isn’t qualified to speak on issues of cardiovascular disease since he’s not a "practicing physician with a valid license in any state."

As Peter Rost over at BrandweekNRX writes, “He's an M.D. but he never actually practiced medicine. Instead he changed the course of medicine, through his work."

Did Jonas Salk ever practice medicine -- or was he too busy saving mankind?

“In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine,” Mr. Dingell said in a press release.

Congress imitates the Colbert Report. Except their writers aren't on strike.

Rost writes. “This is grossly unfair. He clearly went through fire to get his medical degree and had more motivation than most. He then continued a career which led to one of the most notable breakthroughs in medicine. To get on his case and the fact that Pfizer is using him as a spokesperson is simply wrong.”

"Dr. Jarvik,” Pfizer responds, “ is a respected health care professional and heart expert. Dr. Jarvik, inventor of the Jarvik artificial heart, knows how imperative it is for patients to do everything they can to keep their heart working well."

It's Mad Libs for legislators. Insert NAME OF DRUG COMPANY. Insert NAME OF CEO. Insert ACCUSATION. Its fun for the whole family – and the media loves it!

Until it makes you look foolish.

Posted by peterpitts at 08:51 AM
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June 29, 2007

Pharmonic Convergence

by Peter Pitts

Two interesting stories that both reach the same place -- we need to find ways to get the right medicines to the right people at the right time in the right dose. Let's call it "Pharmonic Convergence."

First story comes from the Pink Sheet and their discussion of FDA's genetic test guidelines.

As reporter David Filmore writes vis-a-vis the FDA's genetic test guidelines:

"The agency drafted the guidance document on pharmacogenetic tests and genetic tests for heritable markers to help shorten development and review times for these products, which are attracting growing attention from the medical community as tools to make more precise disgnoses and, in the case of pharmacogenetic tests, more personalized treatment decisions."

Right now, today such tests exist. It is not, as many will derisively tell you, science fiction. It's science fact. And the fact that most insurance companies don't reimburse for such diagnistic tools is short sighted.

To that point, an article from the June 28th edition of the New York Times. Gray Lady scribe Milt Freudenheim reports on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."

"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.

As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."

The lede of the New York Times article reads, "Health penny wise, medical pound foolish?

Indeed.

Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payors interpose themselves between doctor and patient, when prescribing decisions are made by accountants (read "evidence-based medicine"), health outcomes decline for the individual and costs go up for the payor.

Let's keep our eye on the prize as we strive to move from acute to a chronic care model for 21st century health care. It's nothing short of critical.

And, after all, that's why we have the Critical Path.

Posted by peterpitts at 01:11 PM
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April 30, 2007

Drug Ads and Great Expectations

by Peter Pitts

"The doctor of the future will give no medicine, but will interest her or his patients in the care of the human frame, in a proper diet, and in the cause and prevention of disease"

-- Thomas A. Edison

Welcome to PiP.

For those of you out there who aren't fans of Charles Dickens, here's the Cliffsnotes background on the literary character of the same name ...

Great Expectations is the story of Pip and his initial dreams and resulting disappointments that eventually lead to him becoming a genuinely good man. The significant changes that Pip's character goes through are very important to one of the novel's many themes. Dickens uses Pip's deterioration from an innocent boy into an arrogant gentleman and his redemption as a good-natured person to illustrate the idea that unrealistic hopes and expectations can lead to undesirable traits.

Yes, Pip as an allegory for Pharma.

Now welcome to PiP -- Personalized Information to Patients

As Congress debates the (clearly unconstitutional) idea of granting the FDA authority to ban DTC for any new drug's first two years of availability, the science of personalized medicine will ultimately make this debate meaningless.

As we attain the knowledge to prescribe the right medicine in the right dose for the right patient at the right time, patients and physicians will rely more on gene testing than product advertising. Indeed information will no longer only mean information about a medicine or a disease -- it'll mean information about your personal biochemistry -- hence Personalized Information to Patients.

In the not so distant future, ads for gene tests may very well replace and surpass those for medicines. Talk about disease awareness! Talk about early and accurate diagnosis! Talk about moving from an acute to a chronic care model!

But it needs to be more than just science talk and silly pieces of ersatz legislation. And that's where the FDA's Critical Path program comes into play.

If we want health care advertising to move beyond the current Cliffsnotes of health information -- DTC -- to the real deal -- Personalized Information to Paitents -- PiP -- we must create the regulatory tools that allow it to happen.

Otherwise it's just talk.

Posted by peterpitts at 10:03 AM
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January 25, 2007

When is a Drug Risk not a Drug Risk?

by Peter Pitts

When is a drug risk not a drug risk? When you don't understand it. I refer, of course, to the so-called "Brief Summary" which, as some say, is like the Holy Roman Empire -- neither brief nor a summary.

A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.

The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org

Not rocket science. Social science

Posted by Peter Pitts at 10:02 AM
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October 12, 2006

No health care information please, we’re Canadian

by Peter Pitts

Maclean's, Mon 16 Oct 2006

Byline: DANYLO HAWALESHKA

In the pivotal courtroom scene from A Few Good Men, Tom Cruise shouts, "I want the truth!" at Jack Nicholson, whose truculent character is testifying. "You can't handle the truth!" Nicholson famously retorts. Today, in a real-life courtroom drama, CanWest MediaWorks Inc. has, in a manner, assumed Cruise's role, with a somewhat less altruistic goal in mind than simple verity.

In a civil lawsuit now before Ontario's Superior Court of Justice, CanWest contends Canadians are being denied important truths about prescription medications because of strict limits on drug advertising. Canada's largest media company claims the regulations thwart its constitutional right to freedom of expression.

CanWest's suit against the attorney general of Canada casts the country's Food and Drugs Act as the villain. The act forbids direct-to-consumer advertising (DTCA) that ties a prescription drug to a treatment, cure or disease. (It is illegal for CanWest to, for instance, run an ad to promote Viagra for impotence, but quite legal to separately publicize the brand, or the condition; there are no such restrictions on ads that target physicians exclusively in, say, trade journals.)

In a sworn statement, Arturo Duran, a CanWest MediaWorks president, claims permitting DTCA in Canada would educate the public about drug risks and benefits. "There is no evidence to justify a ban on truthful advertising of prescription drugs," Duran says.

Posted by Peter Pitts at 01:07 PM
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October 10, 2006

Bouquets & Brickbats Brussels Style

by Peter Pitts

All is not quiet on the Western Front.

Since the EU’s High Level Pharmaceutical Forum (HLPF) recommended that Europe revisit new, more patient-friendly rules towards direct-to-consumer health care information (what our transatlantic cousins refer to as, “information-to-patients” or “ItP”) the merde has hit the fan.

Hey, you gotta break some eggs to make an omelet.

Bouquets to MEP Jorgo Chatzimarkakis, one of the EU Parliament's three representatives on the HLPF, who finds the current information ban on medicines unacceptable. "I can understand a ban on advertisements but I can not agree on the ban on information, which leads us to a situation where patients are obliged to surf around the Internet to look for information on medicines. Citizens can not be deprived of information by their own governments on such crucial issues as one's health," he argues.

And brickbats to Health Action International (HAI) who claims, “there is no health information gap in Europe.” (www.haiweb.org). HAI (no relation to Hospital Acquired Infections – but you think they would have thought about that before adopting the acronym) disallows with a wave of their hand any useful participation by the pharmaceutical industry in providing patient information because of a “natural conflict of interest.” How very Rousseau. But concepts of natural liberty notwithstanding, HAI offers up al lot of the usual anti-industry accusations without even a scintilla of evidence. I guess since it’s “natural,” no proof is required. Weak argument.

And who does HAI consider excellent sources of patient information? Get this – IQWIG and NICE to name two. Really. I am not making this up.

HAI waves the usual banners of “evidence-based medicine,” “rational use of medicine,” and the “over-medicalisation of the European population.” And they are very clearly adherents to the Precautionary Principle of "doing nothing until you know everything" (not surprising since one of their major funders is the Rockefeller Foundation).

And listen to this, “For each option (of type of medicine) patients should be able to clearly identify benefits (degrees of clinical effectiveness on important outcomes, convenience, etc.) and harms (potential side effects, disturbances of personal and social life, etc.). Yes – and every taxpayer should have a deep and profound understanding of the tax code. How about this as a recommendation – let patients have access to information from every source and then let them speak with their physicians. That’s when good things happen.

“Degrees of clinical effectiveness?” Isn’t that the job of … physicians?

By the way, in case you’re wondering about where HAI gets its money -- out of a total budget of €1.022.169 (2002 figures are the latest available) €557.604 came from the Dutch Ministry of Foreign Affairs. Of that funding, €300.104 was spent on something called the “Drug Pricing Project.”

Aha and indeed. Will better-informed consumers want broader access to more pharmaceutical options? Nuff said. And let's face it; EU governments don’t want to spend the money -- outcomes notwithstanding. No wonder HAI points to IQWIG and ilk as the best sources for consumer health care information.

What a blatant charade.

Information is Power.

Posted by Peter Pitts at 08:26 AM
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September 14, 2006

Qui tacet consentit

by Peter Pitts

The Washington Legal Foundation has filed a petition with the Food and Drug Administration challenging the agency’s right to send warning letters to drug companies whose advertising it finds misleading.

The WLF believes the letters — which carry no legal weight but are routinely obeyed — contravene the First Amendment by making it impossible for drug marketers to advertise information that is not reviewed by the FDA even though it may be truthful and accurate.

Rather than having the WLF file a petition that will not go anywhere, individual pharmaceutical companies should muster the pluck to energetically challenge DDMAC when they receive letters they feel are unfair.

Qui tacet consentit. Silence implies consent.

Posted by Peter Pitts at 07:50 AM
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September 05, 2006

Rosetta Stone doesn't work at the Carnegie Deli

by Peter Pitts

Here’s a link to a new paper (by me) discussing how Europe can learn from America’s DTC experiences (both positive and otherwise) to create a more robust 21st century environment for patient empowerment. My premise is that health care communication is the consumer’s Rosetta Stone.

Your thoughts and comments are much appreciated.

http://www.stockholm-network.org/publications/list.php#31

Posted by Peter Pitts at 04:34 PM
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