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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 Today, the “learned intermediary” has been replaced by the Internet, the patient is the purchaser, and Dr.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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May 29, 2008
More Healthcare for Dummies
by Peter Pitts
Per “Healthcare for Dummies,” I just received an “off the record” comment from a health care reporter I consider to be among the smartest and savviest around. He writes:
"The responsibility lies with editors. If editors rewarded careful, nuanced reporting and rejected crap, reporters would respond. For example, (name deleted) is smart and hardworking and capable of writing thoughtful stories. She also knows that a leak from a defense lawyer of a "gotcha" memo will land her story on the front page, while a careful analysis will go on page C400. And (second name withheld) knows that quotes from Sid 'I always cry' Wolfe will be accepted, so he doesn't have to work hard to seek other voices. A good editor would push for better sources."
Posted by peterpitts at 01:40 PM
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Healthcare for Dummies
by Peter Pitts
"Too often medical reporters haven't been trained in the basics of understanding medical research and evidence-based medicine."
So says Gavin Yamey, senior editor at PLoS Medicine.
This isn't to say there aren't some really terrific, highly aware ones out there as well -- there most certainly are. But they are in the minority. If you agree with Gavin Yamey, the question then becomes, what's the best way to get reporters trained and who should do the training?
Should it be industry? "Advocates?" Academics? Government officials? Medical organizations? Disease organizations? Patient organizations? Should there be a mandatory "health care for dummies" class in journalism schools? The current practice, it seems, is on-the-job training.
The results (often inaccurate, sometimes slanted) are not a service to the health care information consumer (reader, viewer, listener). And there ain't no CME.
What's to be done? Clearly one path is for reporters to reach out to various sources for background -- and to make sure those sources are diverse -- thus guaranteeing a variety of opinions and avoiding undue, single-source bias.
In fact, now that I think of it, that's probably a good idea for all health care reporters -- even those with well-known and well-read bylines.
Posted by peterpitts at 11:28 AM
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May 28, 2008
Punxsutawney Pill
by Peter Pitts
Interesting story in the New York Times about a company that's producing placebos for kids.
According to the article: "Jennifer Buettner was taking care of her young niece when the idea struck her. The child had a nagging case of hypochondria, and Ms. Buettner’s mother-in-law, a nurse, instructed her to give the girl a Motrin tablet. She told me it was the most benign thing I could give, Ms. Buettner said. I thought, why give her any drug? Why not give her a placebo?
Studies have repeatedly shown that placebos can produce improvements for many problems like depression, pain and high blood pressure, and Ms. Buettner reasoned that she could harness the placebo effect to help her niece. She sent her husband to the drugstore to buy placebo pills. When he came back empty handed, she said, It was one of those ‘aha!’ moments when everything just clicks.
With the help of her husband, Dennis, she founded a placebo company, and, without a hint of irony, named it Efficacy Brands. Its chewable, cherry-flavored dextrose tablets, Obecalp, for placebo spelled backward, goes on sale on June 1 at the Efficacy Brands Web site. Bottles of 50 tablets will sell for $5.95. The Buettners have plans for a liquid version, too."
Sounds good? Maybe not. Consider the comments of Dr. Howard Brody, a medical ethicist and family physician at the University of Texas Medical Branch at Galveston. “Placebos are unpredictable. Each and every time you give a placebo you see a dramatic response among some people and no response in others.”
“The idea that we can use a placebo as a general treatment method,” Dr. Brody said, “strikes me as inappropriate.”
Here’s a link to the complete article:
And here’s my take – will products like Obecap teach children that there’s a pill for every problem? Is that a health care message that we want to teach our children? It also reinforces the general mindset that leads to parents demanding antibiotics for ear-aches. Not the way to go. We need to teach our children wellness.
Posted by peterpitts at 02:11 PM
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May 21, 2008
Cell Culture
by Peter Pitts
At a recent European Commission-sponsored high level conference, Internal Market Commissioner Charlie McCreevy, commented that the EC wants practical, pragmatic suggestions for fighting the “modern-day highway robbery” known as piracy and counterfeiting. McCreevy stressed that more regulation is not the answer, and that solutions lie with public-private cooperation.
Don’t get me wrong – I’m all for free-market solutions and public/private cooperation. But when it comes to counterfeit prescription medicines (aka: International Health Care Terrorism) national and international law enforcement agencies as well as domestic criminal justice officials must engage in the debate. And actively. And immediately.
Only governments can put into place enhanced investigatory assets and harsher penalties.
Public/Private cooperation? Certainly. But only governments can catch and keep criminals in jail.
When it comes to discouraging international prescription drug counterfeiting, what we need is a more robust cell culture.
Posted by peterpitts at 06:44 AM
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May 20, 2008
Deal or No Deal
by Peter Pitts
According to a Bloomberg report, biotechnology acquisitions and licensing deals reached a record $27 billion worldwide last year. In the largest deal of the year, London-based AstraZeneca paid $15.6 billion to acquire MedImmune.
Biotechnology companies also raised $29.9 billion in investments and loans, the most since 2000. The industry attracted a record $39.4 billion in 2000, the year the first draft sequence of the human genome appeared.
IPOs brought in $2.2 billion, a 21 percent increase over the previous year and the highest total since 2000.
The full Bloomberg story can be found here:
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a6FjDvLrCCgm
The article mentions that, “Large drugmakers are investing in biotechnology to gain new medicines to bolster revenue as patents on top products expire.”
No doubt. But while acquisitions and licensing is the wave of the present, what will drive the future of pipeline, profit … and public health is the Critical Path. To achieve “A” level health care, industry and academia and government must focus on “B” level issues -- Better science and better tools (biomarkers, bioinformatics, and Bayesian statistical analysis) among others.
So, deal or no deal, the Critical Path must not remain the road less traveled.
Posted by peterpitts at 07:52 AM
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May 12, 2008
The Lancet on Counterfeits
by Peter Pitts
The Lancet 2008; 371:1551
DOI:10.1016/S0140-6736(08)60663-7
Editorial
Combating counterfeit drugs
Last week, the US Food and Drug Administration (FDA) told a Congressional hearing that it believes a contaminant found in batches of heparin, which have killed at least 81 patients, might have been deliberately added. The source of the contaminant—oversulfated chondroitin sulphate—has been traced back to a Chinese supplier of drug manufacturer Baxter International. Why the stocks might have been intentionally contaminated is unclear, but the fact that oversulfated chondroitin sulphate is structurally similar to heparin but about 100 times cheaper, raises the very real possibility that it could have been added by counterfeiters.
If counterfeiting is behind the heparin case, it would not be that surprising; trends indicate that counterfeit medicines, defined by WHO as drugs that have “been deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing, global problem. The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing countries, where drug regulatory systems can be weak or non-existent, around 10–30% of medicines might be counterfeit. Antimalarials have been a particular target for counterfeiters, and fakes have flooded the market in many Asian countries.
The substances used to adulterate medicines can vary from chalk, to antibiotics, to highly lethal substances that cause alarming spikes in mortality rates. Subtherapeutic levels of the genuine medicine, such as an antimalarial, can also lead to death or the development of fatal drug resistance. But these deaths, mainly in developing countries, are largely hidden in public-health statistics.
This situation is only likely to worsen as counterfeit drugs are becoming more difficult to combat. Criminals are using more sophisticated techniques to bypass standard laboratory testing such as the addition of cheaper substances that mimic genuine drugs. Holograms on drug packaging, designed to make counterfeiting more difficult, are also being copied with increasing accuracy making boxes of fake products hard to detect by the human eye. These deceptive measures have unfortunately led to a booming, lucrative trade. The Center for Medicine and the Public Interest estimates the sales of counterfeit drugs will reach US$75 billion in 2010. So what is being done to address the problem?
At the international level, the World Health Assembly adopted a resolution against counterfeit and substandard drugs in 1988, and at the end of 2006, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was set up by WHO to mobilise action. However, despite these moves, few concrete steps have been taken by countries and political will to adopt anti-counterfeiting measures is lacking.
Most WHO member states are doing a poor job of reporting counterfeiting cases. Incredibly, between 2002 and 2004, WHO received no reports of counterfeit drugs. In many countries, counterfeiting medicines is not even considered a crime and when it is, the penalties for those found guilty often do not tally with the severity of the action. For example, in the UK, the prison sentence and fine for counterfeiting a T-shirt with a trademarked logo can be greater than for counterfeiting a medicine. Tougher prison sentences and heftier fines need to be introduced by governments to deter counterfeiters.
Countries must also strengthen their ability to regulate the drug supply. According to WHO, only 20% of its member states have well-developed drug regulatory systems, and around 30% have no or weak drug regulation. Twinning food and drug authorities in rich countries with ones in resource-poor countries might help nations that are struggling to regulate the market. Drug authorities also need to work effectively with customs, the police, scientists, health workers, WHO, and INTERPOL. This type of collaborative approach has proved successful in tackling counterfeit antimalarials in southeast Asia.
The pharmaceutical industry also has its part to play. It should be legally required to report suspected cases of counterfeiting to the relevant national drug authority—a practice which is currently voluntary. Companies must also be encouraged to lower the prices of their products in developing countries to reduce the economic incentive for counterfeiters.
There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidicisplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised.
Posted by peterpitts at 07:37 AM
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May 09, 2008
Tribulations and Trials
by Peter Pitts
According to David Lepay, the FDA's senior advisor for clinical science, the agency and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials.
Existing FDA regulations do not take into account all the different types of organizations — vendors, co-investigators, site management organizations and contract research organizations — involved in conducting clinical trials.
FDA regulations fail to account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms. “We are working with groups within and outside the FDA to address this,” Lepay said at the annual conference of the Association of Clinical Research Professionals.
The FDA also is working to improve its internal processes to address “why it takes so long to disqualify clinical investigators” caught in wrongdoing, Lepay said. Recently, U.S. Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.) asked the Government Accountability Office to examine why the agency has been so slow to discipline investigators.
It's not a question of doing it fast. It's a question of doing it right.
Posted by peterpitts at 09:25 AM
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May 08, 2008
Lord of the Flies
by Peter Pitts
Chinese regulators are accusing Baxter of failing to co-operate in an investigation over deaths linked to impurities in blood thinner heparin.
The State Food and Drug Administration, China’s drugs regulator, said on Tuesday that Baxter had not provided all samples and information requested during a visit last month to its New Jersey plant. The SFDA reiterated its position that there was no proven link between the deaths in the US of patients and “a heparin-like substance” found in the drug.
Denial, as my mother used to say, is more than just a river in Egypt.
Baxter replied: “We have been co-operating with all parties in the heparin situation including SFDA and the Chinese government. We plan to continue co-operating with them to help move the investigation forward. We will seek to understand any concerns to the contrary.”
Per the larger issue of “tainted” vs. “counterfeit” ingredients, consider the comments of Robert Parkinson, Baxter’s chief executive, who said that the issue in question “appears to be the target of a deliberate adulteration scheme.”
Translation: Counterfeiting.
There are a lot of issues here that need to be addressed – most notably criminal opportunism.
Consider the Chinese proverb, “Flies never visit an egg that has no crack.”
We must seal the cracks.
Posted by peterpitts at 07:35 AM
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May 07, 2008
False Profits
by Peter Pitts
In 2006 the Center for Medicine in the Public Interest (www.cmpi.org), estimated that counterfeit drug commerce will grow 13% annually through 2010. The CMPI study is cited by the WHO on its updated counterfeit pharmaceuticals fact sheet.
Counterfeit sales are increasing at nearly twice the rate of legitimate pharmaceutical sales and they are a money machine. In 2010 CMPI estimates that fake drugs will generate $75 billion in revenues — a 92% increase from 2005. And the risks of detection and prosecution are low.
CMPI's original estimates were made based on conservative projections of counterfeit medicines manufacture and sales issued by the WHO, the FDA, the EU Commission and other global bodies.
But now these numbers are too low – because an entirely new criminal enterprise has emerged – counterfeit ingredients. While counterfeit API (active pharmaceutical ingredient) isn’t a new issue, there is a new and frightening manifestation. In the past, counterfeit API was purchased by criminals making counterfeit drugs. Today a new, significantly more dangerous and difficult to fight enterprise is underway – the sale of counterfeit (“tainted”) ingredients to legitimate pharmaceutical manufacturers. The most high profile example of this is the deadly case of Heparin.
It is impossible to believe that the case of Heparin was an unfortunate mistake – a quality lapse, a one-time and unique circumstance. The facts speak otherwise. This was a case of fraud. Criminal fraud. So let’s call it by its proper name -- counterfeiting.
Counterfeit medicines, according to the WHO are “deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.”
It’s time to rethink and broaden that definition to include the potential for fake ingredients (“tainted” is both too polite and too inaccurate a term) that insidiously find their way into legitimate pharmaceutical manufacturing.
Posted by peterpitts at 02:31 PM
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May 06, 2008
Value vs. Volume
by Peter Pitts
Last Thursday, in Chicago, HHS Secretary Mike Leavitt kicked off the 28th annual Midwest Business Group on Health conference (smartly themed “Survivor: Health Benefits Island”). He made some interesting points:
The first is that we need to redesign our healthcare system so that we reward “value rather than volume.” No argument there. It’s also very much in keeping with what Senator McCain is talking about these days.
He then turned his attention to the HHS “efficiency roadmap.” Lots of good initiatives. (I know, there are always a lot of “good initiatives.”) What was missing, however, was how to overcome one of the most significant roadblocks – state lines. Specifically, in addressing a group made up of large employers, the Secretary didn’t discuss insurance deregulation as a strategy towards more affordable, accessible, and patient-centered coverage. This must be a key strategy in the “value vs. volume” proposition.
He spent the lion’s share of his remarks (and productively so) talking about the need for inter-operability of healthcare IT platforms – where HHS has helped to both design and implement some successful programs lead the still nascent national dialogue.
One comment he made is worth repeating for both its wit and honesty. Leavitt quipped that “the wonderful thing about healthcare standards is that there are so many to choose from.”
And may we all live in interesting times.
Posted by peterpitts at 07:39 AM
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