God's Speed, Patty Delaney

• 06.03.2008

Sad news is no less sad when you know its coming.

Patty Delaney has passed away. Her 20-year battle against cancer was as epic as it was public. But it was never about Patty.

For Patty it was all about every other cancer patient. To say that her job as the FDA’s Office of Special Health Issues Cancer Liaison was “more than a job but a calling” is too trite and does not do justice to the woman and her warmth, her professionalism and her tenacity.

And her depth of caring. And her intensity. She was a pit bull. She was profoundly dimensional. Her legacy is breathtaking. We must all strive to live up to it -- and not let her down.

Writing about her in the past tense is painful.

God’s Speed, Patty Delaney.

Sid Wolfe on Speed (dial)

• 06.03.2008

Much ado about pharma freebies to physicians. Much ado about nothing medically. Much ado about everything politically. And the media is the message.

Witness today's story about romancing medical students.

The New York Times reports that, “Most medical schools the United States fail to police adequately the money, gifts and free drug samples that pharmaceutical companies routinely shower on doctors and trainees, according to a ranking by the American Medical Student Association."

According to Dr. Brian Hurley, president of the AMSA, “These policies are incredibly important to protect the educational experience students have at school and the quality of the education they’re getting.” The Times reports that, "Schools that shield students from marketing messages will produce doctors who provide better care to patients, Dr. Hurley said."

Really? Why is that? No evidence provided. Just empty rhetoric but, since it’s in the New York Times, fit to print.

The Times’ story continues, “The role played by pharmaceutical and device makers in the education of doctors has become an increasingly controversial topic, with some top medical schools placing a growing number of restrictions on the longtime practice of providing free food, gifts and educational seminars to trainees.”

But, again, no facts to show why this isn’t anything more than a tempest in a teapot being brewed by the usual suspects.

And, speaking of the usual suspects – guess what public policy expert the Times quotes on the matter? Yup – Sid Wolfe.

“Most of the medical school bureaucracies are getting too much money and other forms of largess from the drug industry to initiate these healthy, long overdue policies on their own,” Dr. Wolfe said.

Here’s a link to the complete story in today’s Times:

http://www.nytimes.com/2008/06/03/health/03conflict.html?ref=health

Where’s the other side of the argument? Invisible in today's New York Times, but it’s there. It’s important. It’s not hiding. In fact, it’s easy to find and high profile.

Consider the recent op-ed in the Boston Herald by Dennis Ausiello and Thomas P. Stossel (both of Harvard Medical School). And then consider what they have to say on the topic – balderdash!

In their own words,

“The real intent of these critics goes far beyond food and trinkets, and its true purpose is to curtail strictly or even eliminate all contacts between physicians and private industry. We strongly oppose this agenda.”

“… Despite extensive training, physicians cannot know the details of all products, especially new ones. Therefore, company salespersons complement physicians’ information derived from many sources. They tell physicians about a limited range of products about which their employers train them under strict FDA regulations.”

“… We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps.”

Here’s a link to their complete op-ed:

http://bostonherald.com/news/opinion/op_ed/view.bg?articleid=1087609

It wasn’t hard to find. In fact, it was made easier by the fact that Dr. Stossel testified in front of Congress on this issue – recently.

Having Sid Wolfe on speed dial may be easier, but it doesn’t lead to better, more balanced or informative reporting.

What Mark Thornton Did Not Disclose

• 06.02.2008

Clarification from the Grassley Knoll

• 06.02.2008

Dr. Mark Thornton, in a recent Wall Street Journal op-ed, wrote that Senator Charles Grassley, "is demanding a full-scale review of each and every product ever approved," and is asking for a rejudgment by GAO "to ensure that drugs approved on surrogate endpoints are both safe and effective."

Which caused the following clarification from the senior senator from Iowa,

"Surrogate end points are a valid way for the FDA to approve drugs."

Thanks to Mark (a CMPI board member), Senator Grassley was forced  to admit that 21st century science is appropriate for the regulation of 21st century medicines.

When it comes to advancing the public health, there shouldn't be any room for political rhetoric.

(But, alas, we live in the real world. All the more reason to call it like we see it.)

A Liberal Life is Worth Saving

• 06.02.2008

Weak End at Bernie's

• 06.02.2008

According to an article in livemint.com (the Wall Street Journal’s news partner in India), “For the first time ever, a consensus has evolved on creating global patent databases, monitoring drug prices and encouraging companies to differentially price their drugs, as a burgeoning health care bill pushes governments towards sourcing cheaper medicines.”

The initiative, part of a draft agreement adopted by all the countries in the World Health Assembly in Geneva recently, has been “cheered by public health advocates and makers of generic or off-patent drugs.” The assembly is an apex group of member nations at the World Health Organization or WHO.

The health assembly has, in its draft, also asked member nations to “encourage pharmaceutical companies and other health-related industries to consider policies, including differential pricing” to promote availability of affordable drugs and consider “development of policies to monitor (drug) pricing.”

The concept of differential pricing has been kicking around for some time with some success. Now, together with an up-to-date patent database, we should expect to see more of it. Most people think this is a good idea.

Novartis India Ltd's managing director Ranjit Shahani, who was the president of Organization of Pharmaceutical Producers of India, a lobby of foreign-owned drug makers in India, called differential pricing “directionally positive” and ones that recognize people's varying paying capacity, though the implementation should be through a workable model.

But not everybody is happy.

The clause for “drug monitoring” has failed to impress those of the Jamie Love school of “prizes for patents.” “Monitoring prices is a good step but controlling prices would have been a better and stronger one,” said Kajal Bharadwaj, a lawyer specializing in drug access-related patent issues and added that the health assembly text “legitimizes and validates the public health hedges in government policies that countries like India, Thailand and Brazil have been sticking up for”.

Actually, that’s not true. Clearly Ms. Bharadwaj would like it to be true and so, in typical Big Lie fashion, she will simply keep saying it’s true. This is the same tactic Jamie Love uses when he tells people in Europe that legislation in the United States calling for prizes to replace patents is going to become the law of the land. (FYI – this bill was authored by Senator Bernie Sanders, the Socialist Senator from Ben & Jerry’s and has, as of this writing, zero co-sponsors.)

Here's the complete livemint article:

www.livemint.com/2008/06/01232744/Draft-WHO-pact-on-drugs-cheere.html

"Page" Turner

• 06.02.2008

A few weeks ago I was on a panel with J. Rick Turner, Chairman of the Department of Clinical Research and Director of the Cardiac Education Center at the Campbell University School of Pharmacy.  And, as usual, the most interesting part of the conversation happened after the panel was over.

As we were gathering our papers and checking our blackberries, Dr. Turner mentioned that he had written a new book on the issue of “integrated cardiac safety.”  I asked him to send me an advance copy.  And he did.

They don’t call him “Page” Turner for nothing.

His new book, “Integrated Cardiac Safety:  Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Post Marketing Surveillance,” is a timely and important addition to the debate over drug safety and, equally important, safe use.

Consider the following brief excerpts:

“A drug’s development in the sense of improving its safety and/or effectiveness profiles does not stop at the point of marketing approval.  Data collected during the drug’s use in large patient populations can lead to meaningful improvements in the drug.  This term, lifecycle drug development, therefore emphasizes that it is vital to remain vigilant about the drug’s effects from the very beginning of the drug discovery phase throughout the entire time that the drug is on the market and hence available for prescription to patients, and it captures the spirit of this book very well.”

“So too does the term integrated cardiac safety.  A central tenet of this book is that it is beneficial to discuss the assessment methodologies used to collect information on cardiac safety at four stages of lifecycle drug development—drug discovery and design, nonclinical development, preapproval clinical development, and postmarketing surveillance—in one book, and to integrate this information to the greatest degree possible.” 

“Meta-analyses vary in the number of patients included since this is dependent on the numbers in the individual trials combined in the new analysis.  However, typical numbers are also in the thousands. However, it is fair to say that statistical methodology is currently less well developed in the case of epidemiology studies than it is for randomized controlled trials: this is not meant as a pejorative statement, simply a statement of the current state of affairs that will hopefully and very likely change as additional spotlights on and developments in the field of pharmacoepidemiology increase.”

“It should also be noted here that the term nonexperimental is not a pejorative one compared with the term experimental.  Piantadosi discussed two fundamental types of study design, experimental and nonexperimental.  In experimental studies participants receive random treatment allocation, and observations are made under conditions in which the influence of interest is controlled by the research scientists.   In nonexperimental studies the research scientist also collects observations but does not exert control over the influences of interest.  Nonexperimental studies are often called ‘observational studies,’ but this term is inaccurate: it does not definitively distinguish between nonexperimental studies and experimental studies, in which observations are also made.”

The book, due out in November of this year is must reading – especially for Steve Nissen.

Obama's Off-Label Nicorette Use

• 06.01.2008

It’s taken 20 years but Barack Obama has once and for all quit. Not Trinity United Church of Christ, but smoking, a habit he picked up around the same time he joined the controversial ministry.

To do so, he has been chewing Nicorette, the smoking cessation gum. And he’s been chewing it longer and in larger amounts than is on the label.

Is Obama’s off-label use bad or dangerous? According to the dictates of Tabloid Medicine, of course it is.

However, Tara-Parker Pope puts his Nicorette consumption in proper perspective:

“Mr. Obama has said he started using the nicotine gum Nicorette about nine months ago. That’s six months longer than the three months recommended on the gum package label. And Mr. Obama is not the only quitter who is still seeking a nicotine fix months after giving up cigarettes. A small percentage of the people who use nicotine replacement products like gums or lozenges end up hooked on a new habit, say doctors who specialize in smoking cessation…..”

However…

“The problem is not that people use it too much,'’ noted Lynn T. Kozlowski, interim dean of the school of public health and health professions at the University at Buffalo. “The greater problem is that they use it too little. People use it for a week, and then they are back smoking cigarettes.”

well.blogs.nytimes.com/2007/11/02/obamas-new-addiction/

Then there is the individual variation in nicotine dependence shaped by genetics. A paper entitled: "Single Nucleotide Polymorphisms, Clinical Trials, and Tobacco Research: The Search for the Smoking Gun," explored the associations between genetic variations, nicotine usage, and the potential effects on smoking cessation techniques according to a press release from the American Society of Clinical Oncology.

This explains differences in Nicorette uses and variations in response to Chantix.

Someone might want to send that paper to Senator Grassley and Alicia Mundy of the WSJ both of whom seem eager to blame side effects of Chantix on a FDA-Pfizer coverup instead of “genetic variations at the receptor level, the drug metabolism level, or both.”

Read ASCO Article

That would be intellectually honest

Mundy Morning Quarterbacking About Pharma At the WSJ

• 05.30.2008

Old News is Good News

• 05.30.2008

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?”