Merck witness has chink in armor

During the past five months, Merck researcher Alise Reicin has stood toe-to-toe with some of the nation's best trial lawyers.
Described by her bosses at the New Jersey pharmaceutical company as a "tenacious defender of the Vioxx franchise," she has been Merck's most reliable witness in the three trials so far involving the once-popular painkiller.
Now, she's on trial as much as the drug itself.
That's because of a bombshell last month from the editors of the New England Journal of Medicine. They accused the authors of a key study on Vioxx of fudging the data, and making the drug look safer than it was. Reicin was a co-author of the Vioxx study, and plaintiffs attorneys say the editorial undercuts her testimony that Merck acted responsibly.
"The essence of the problem is when you have a witness who has a halo over her head, and crystalline credibility, any ding in that can shatter the entire aura and cast her as a profits-before-science marketing adjunct," said Sam Davis, a Teaneck attorney who is representing hundreds of Vioxx plaintiffs.
Reicin, a 45-year-old scientist, who lives in Englewood, helped design the clinical trials that led to the drug's regulatory approval in 1999. And she has consistently provided the scientific underpinning to Merck's claim it acted in good faith before pulling the drug from the market in September 2004, after a study linked it to an elevated risk of heart attack and stroke.
More importantly, she has shown the ability to win over a jury. After the first New Jersey case in Atlantic City last fall, jurors said they found her to be particularly credible. Merck won that case, after losing weeks earlier in a case in Texas. Later, a federal lawsuit in Houston ended in a mistrial. Merck faces more than 9,000 lawsuits around the country.
"Clearly, Dr. Reicin is a star witness for Merck," said plaintiff attorney Andy Birchfield, who nonetheless said he is looking forward to raising the New England Journal's concerns in his retrial of the first federal Vioxx case, which begins Feb. 6 in New Orleans.
LOOKING FOR INCONSISTENCIES After the editorial appeared, plaintiff attorneys immediately began combing Reicin's testimony for discrepancies. Four weeks later, no blatant contradictions have emerged.
Texas attorney Mark Lanier, who won a multimillion-dollar verdict against Merck last summer in the first Vioxx trial, has backed away from comments that he planned to pass information along to law enforcement officials. In an e-mail last week, he said he is saving inconsistencies he has found for a Vioxx case he is trying in New Jersey at the end of February.
Chris Seeger, one of the plaintiff attorneys who lost the first Vioxx case in New Jersey last fall, has said he wanted to add the New England Journal revelations to his motion for a new trial.
Seeger had not done so as of Friday, but it is possible the information could be included in time for a hearing before Superior Court Judge Carol Higbee later this month. Seeger did not return calls seeking comment.
Merck, meanwhile, insists it is keeping Reicin in its lineup of witnesses. Company lawyers pored over her testimony in the three trials, and found nothing of concern, said Ted Mayer, an outside counsel for Merck.
"What she testified to was entirely truthful and straightforward," Mayer said.
GOOD WITH THE JURY It's not surprising Merck will continue to rely on Reicin, even if the risks have gotten higher. In court, she is imperturbable under questioning. During breaks in testimony in Atlantic City in October, she routinely turned to the jury and smiled -- at one point, mouthing the words "It's cold in here," according to Davis, who was attending the trial.
"She comes across to the jury as knowledgeable, authoritative and articulate," said Daniel Keller, a New York plaintiff attorney who sat in on her testimony in the first Vioxx trial in Texas last summer. "She did a pretty good job presenting alternate views of some of Merck's most damning documents."
The medical journal's editors claim the authors of a Vioxx study named Vigor, published in 2000, failed to mention three heart attacks among those given the painkiller and also deleted other relevant safety information. The heart attacks were significant, the editors say, because they occurred in patients at a low risk of cardiovascular problems.
The authors of the study have said the three heart attacks occurred after a firm cut-off point for data, and are preparing a formal response to the New England Journal.
Reicin, who declined to be interviewed while litigation continues, did offer a brief written statement on the controversy.
"Ensuring the integrity of scientific data is of utmost concern to me as a doctor and scientist, and I would never do anything to compromise that principle," she said. "I have been honest and consistent in my testimony regarding the availability of the Vigor data and its disclosure to the New England Journal of Medicine and the Food & Drug Administration."
Keller, a former defense lawyer for pharmaceutical companies who now represents Vioxx plaintiffs, said Reicin will have to spend part of her testimony defending herself, instead of Merck.
"Its pretty simple: it dilutes her testimony," he said. "She'll be prepared to deal with it, but the facts are the facts."
'INTENSE AND SERIOUS' Reicin, who took Vioxx herself before it was withdrawn, is married to a managing director of Morgan Stanley, and has three children ranging in age from 9 to 15. Her father helped run a unit of a family business, M. Putterman & Co., that makes gym floor covers, industrial containment systems and other products. In testimony in Atlantic City, Reicin said her parents stressed the importance of education, and giving back to society.
"I developed an interest in science, an aptitude for science, and so it was kind of natural to decide to pursue a career in medicine, where I could combine science with the ability to help people," she said during the Atlantic City trial in October.
Reicin graduated summa cum laude from Barnard and went on to Harvard Medical School. She did her residency at Columbia-Presbyterian Medical Center, and conducted research on the HIV virus at Columbia.
"AIDs was the epidemic of my generation," she said.
Her mentor at the university, Stephen Goff, called her a terrific researcher who did well at "very hard-core, basic science."
"She's incredibly intense," Goff said. "She's very serious about science."
Reicin moved to Merck because she believed she could have a greater impact on patients' lives.
Despite her responsibilities on litigation, Mayer said Reicin continues to work on clinical research. He declined to say what projects they are.
"That continues to be her primary role," she said.

Larry Sobal column: There's a mess beyond Vioxx

Last month, it was all over the news that a U.S. federal judge in Houston ruled that the latest trial involving Vioxx was a mistrial due to a hung jury.
To refresh your memory, Vioxx is a prescription painkiller manufactured by drug giant Merck. The drug was released in the market in 1999 after the Food and Drug Administration ruled it safe. After being dogged by safety concerns, Merck pulled the drug from the market in September 2004 after studies showed in doubled the risk of heart attacks and strokes in patients who took it for 18 months or longer.
The Houston trial is just one of 7,000 Vioxx lawsuits against Merck. So far, one jury has awarded $253 million to the family of an individual who died while taking Vioxx while another jury found no Merck wrongdoing in a similar case.
While this makes for good media fodder, the question I have — so should you — is whether the Vioxx situation is really a symptom of a diseased pharmaceutical industry in need of major reform.
There are huge dollars at stake in the world of drug development. Vioxx was a blockbuster drug that generated roughly $2.5 billion in annual sales and Americans are now spending in excess of $200 billion a year on prescription drugs. Drugs are the fastest-rising component of health care costs.
At first glance, it would appear that drug manufacturers are simply pursuing capitalistic incentives geared to turn out a steady stream of innovative medicines that lengthen life, enhance its quality and avert more expensive care. If successful, we reap the benefits of miracle drugs and they reap the benefits of handsome profits. However, once you get past this altruistic view, a closer inspection reveals major concerns.
My first concern is that the profitability of drug companies is the barometer by which all other industries are measured. In fact, for more than two decades, the drug industry has clearly been the most profitable in the U.S. In 2002 the combined profits for the 10 drug companies in the Fortune 500 ($35.9 billion) were greater than the cumulative profits for all other 490 companies put together ($33.7 billion).
My next concern is that drug industry is not a model of free enterprise, but one utterly dependent on government-granted monopolies (in the form of patents from the FDA) and is no longer focused on brining new miracle drugs to market. The reality is there are few new innovative drugs being brought to market. The vast majority of "new" drugs entering the market are variations on existing drugs. These "me-too" drugs are often just a molecular variation of an existing product and developed just before the patent expires.
There is a lot at stake related to patent approval. Once patent exclusivity expires, usually averaging around 14 years, generics flood the market and are often priced at less than 20 percent of the name brand and profits subsequently plummet.
Since the FDA controls the drug approval process, one would hope that this organization takes an unbiased stance and always acts in the best interests of the public. With around 3,000 lobbyists targeting Washington, no other industry spends more money with more people in order to sway public policy, and the FDA has made some questionable decisions to protest pharmaceuticals.
Among the changes I advocate are that the FDA should only provide patent protection to a drug if it is deemed to be "better" in some distinguishable way versus other drugs already on the market. In addition, the FDA needs to take back control of how drugs are tested by the manufacturers so that all clinical trials are fully disclosed. These are but a few of the changes needed to clean up the corporate drug scene.

Drug profits infect medical studies

SEVERAL OF OUR most venerated scientific journals have recently been besmirched by allegations of scientific misconduct. Shocking? We should be just as shocked as Inspector Renault when he discovered gambling at Rick's Cafe in Casablanca.First, the New England Journal of Medicine made public its concerns about crucial data having been withheld from its 2000 report on a study sponsored by Merck exaggerating the safety of its blockbuster drug Vioxx, now withdrawn. Then the lead author of a seminal article published in the journal Science reporting the creation of viable stem cells from cloned human embryos admitted he falsified results and resigned his academic post in disgrace.
This week brings the news that a Johnson & Johnson subsidiary failed to include the deaths of two patients in a clinical trial of its new drug for heart failure, Natrecor, in an article published in the Journal of Emergency Medicine.Why shouldn't we be surprised? Because over the last 25 years, clinical research has been largely privatized. Three-quarters of the clinical studies published in the three most respected medical journals (the New England Journal of Medicine, the Journal of the American Medical Assn. and the Lancet) are now commercially funded. As a result, our medical knowledge grows not in the direction that best improves our health but toward corporate profits, the way that plants grow toward sunlight.This wasn't always so. Before 1980, most medical studies were publicly funded, and most academic researchers scorned industry support. Now, however, the vast majority of clinical trials are commercially funded, and with the financial stakes so high, there is mounting evidence of individual scientists and corporations manipulating their findings.Even our most trusted journals are dependent on drug-company money. Drug makers don't just buy advertising in their pages. According to Richard Horton, editor of the Lancet, they also pay up to $1.75 million for reprints of articles favorable to their drugs, which sales reps then hand out to doctors.And many journal articles are biased in favor of their sponsors' products. A 2003 report in the Journal of the American Medical Assn. found that clinical studies funded by drug companies are three times more likely to conclude that the sponsor's drug is the treatment of choice, compared to studies of the same drug that were not commercially funded. (This study of the effects of commercial bias, by the way, was funded by Danish research institutions.) The disturbing conclusion is that most of the evidence in what doctors believe to be "evidence-based medicine" is more infomercial than dispassionate science.It's vital to protect the integrity of our medical knowledge. But the current peer review system alone can't do the job. The journals, and the peer reviewers they rely on, are in the untenable position of having to trust that corporate sponsors have accurately and completely reported their findings. At present, journal editors and peer reviewers typically are not allowed unrestricted access to the data from commercially sponsored research. Amazingly, many drug company-funded researchers who write the articles are also not allowed access to all of the data the company has collected.There is no better cautionary tale than the unwarranted success of Vioxx. Greater safety was the only reason for doctors to have prescribed Vioxx, given that it provided no better relief of arthritis symptoms or pain and cost up to 10 times more than the older anti-inflammatory drug, naproxen (sold without a prescription as Aleve). But Merck's own study clearly showed that Vioxx was more dangerous than naproxen overall and caused significantly more heart attacks, blood clots and strokes — whether or not the patient had a previous history of cardiovascular disease.SO WHY DID American doctors prescribe $7 billion worth of Vioxx after Merck and the Food and Drug Administration knew all this?Because the New England Journal article that ostensibly reported the results of Merck's study didn't even mention either the cardiovascular or the overall dangers of Vioxx. Instead, it reported only selective data on heart attacks and strokes, allowing Merck to claim that Vioxx wasn't a risk to people without a history of these problems.The Journal's editors are now accusing Merck of withholding critical data. Shame on Merck. But shame on the Journal too for not insisting that the article include a discussion of the most important complications. Doctors were left with the impression that Vioxx was safer than naproxen when exactly the opposite was true.The Journal again misled its readers in 2001, when one of its influential review articles dismissed the dangers of Vioxx as perhaps reflecting "the play of chance." This article was published seven months after FDA reviewers' concerns and Merck's own research data, which documented the dangers, had been posted on the FDA's website. Worse, the Journal violated its own policy prohibiting scientists with conflicts of interest from writing review articles. (Both authors had financial ties to Merck.) That the Journal disclosed those ties mitigates neither its ethical breach nor the consequences of its repeated understatement of the risks of Vioxx.This is hardly an academic argument. According to an article in the Lancet, based on Merck's own data Vioxx probably caused between 88,000 and 144,000 cases of serious heart disease.The stem cell and Natrecor debacles offer further evidence that the problem is not just individual bad actors or occasional lapses of scientific integrity by drug makers. It's that even the most prestigious journals are unable to perform the quality control that doctors take for granted.Sadly, the evidence shows that it's time for the journals to change their policies from trust to "trust, but verify." They should introduce a new standard requiring an independent audit of the accuracy and completeness of research reports before they are sent out for peer review. These scientific auditors should be statisticians and medical experts who are completely free of conflicts of interest and are given unfettered access to the data.The journals will rightfully claim they cannot afford to pay for such scientific oversight. But the lack of oversight is even more costly. Americans waste billions each year on drugs of dubious value. Until we find a way to fund quality controls on published research, the cost of our medical care will continue to soar and our health will suffer.

Vioxx case set in Starr County

The nation’s fourth lawsuit against Merck & Co.’s Vioxx painkiller, linked to heart problems, is set for jury selection Jan. 24 in a Starr County courtroom.
The family of Leonel Garza sued the New Jersey pharmaceutical company, two McAllen doctors and a Harlingen clinic in March 2003 after the 71-year-old Rio Grande City man died of a heart attack one month after taking Vioxx. The 12-member jury that Merck’s and Garza’s lawyers will select from Starr County residents is expected to render a tie-breaking verdict against the nation’s fifth-largest pharmaceutical company, which faces more than 9,000 lawsuits over the painkiller recalled in 2004 after studies showed it increased the risk of heart disease and stroke.
So far, Merck has lost one case, won another and had a third end in a mistrial.
In August, a Brazoria County jury found the company responsible in the drug’s first case and ordered Merck to pay $253 million to the family of a Wal-Mart manager who died of heart problems after taking Vioxx for about eight months. The company is appealing the verdict. In November, an Atlantic City, N.J., jury found the company not responsible in the nonfatal heart attack of an Idaho postal worker. Then, in December, a federal judge in Houston declared a mistrial after a jury could not decide if a Florida man’s monthlong use of the drug led to his fatal heart attack.
Most of the plaintiffs claim that Merck knew of Vioxx’s potential danger long before recalling the drug but did not act on concerns so they could keep the profitable drug on the shelves. The company claims it did not act irresponsibly and disclosed its research on the drug.
The third case heard in Texas is set in 259th state District Judge Alex Gabert’s courtroom. Garza’s case could take a month to present all the evidence to the jury, according to the family’s attorneys, the McAllen law firm of Hockema, Tippit & Escobedo.
They claim the company has tried to stall the case, originally set for trial Feb. 14, 2005, employing state legislators with law practices to file continuances and asking that a federal judge hear the case.
"Merck has done everything in its power to deny the Garza family their day in court. This included two remands to federal court and the hiring of multiple state representatives for the sole purpose of stalling this trial," said Joe Escobedo Jr., a lead attorney representing the Garza family.
"We look forward to representing the Garza family and exposing Merck’s greed and corruption in relation to Vioxx."
In January, state Sen. Juan "Chuy" Hinojosa, D-McAllen, entered Merck’s defense team for one day and the company filed a motion of legislative continuance, allowing the trial to stall until after the session ended. However, the next day, Hinojosa withdrew that motion, claiming Merck’s lawyers never told him that they had planned to file a motion of continuance. Hinojosa said he did not read the affidavit he signed attached to the motion and later withdrew from the case.
The next day, the company hired Rep. Rene Oliveira, D-Brownsville, and filed a second legislative continuance. Oliveira is a partner in the Brownsville law firm of Roerig, Oliveira & Fisher LLP and originally joined the defense team as lead counsel.
However, on Dec. 5, Merck filed a motion adding Ricardo Cedillo of the San Antonio firm Davis, Cedillo & Mendoza as lead counsel.
Oliveira said he is actively participating in the case and preparing for trial.
"We’re confident that any fair jury will find that Merck and the product Vioxx had nothing to do with the unfortunate passing of Mr. Garza," Oliveira said.
Merck’s defense team includes Baldemar Garza in Rio Grande City and Houston lawyer Richard Josephson of Baker & Botts.

Expert Opinion on Drug Safety Launches an Open-Access Correspondence Section

LONDON, January 6 /PRNewswire/ -- Since the withdrawal of Vioxx, issues surrounding drug safety, adverse events and pharmacovigilance have become more important than ever, leading to a plethora of debate and discussion regarding drug safety issues. The fine balance between benefit and risk means that there are many differing opinions from experts spanning different disciplines including pharmacology, clinical medicine, pharmacoeconomics and regulatory affairs. Over the last year, Expert Opinion on Drug Safety has seen an increase in the amount of feedback received. To accommodate this, the journal has launched a correspondence section, in which readers can address issues arising from reviews published in the journal. This correspondence section also allows the author to reply, thus stimulating interesting debate - an important forum for discussion.
According to Dr John Barrett, Senior Director - Infectious Diseases, Merck Research Laboratories, "Expanding the journal with the addition of a correspondence section has enhanced the journal's impact by providing for lively and timely exchange of opinion."
All letters published in the correspondence section are freely available online at www.ashley-pub.com/eds.
Published six times a year, Expert Opinion on Drug Safety seeks to unravel the vast amount of drug safety information and provide clear and informed guides. Each article contains an 'Expert Opinion' section, in which authors are encouraged to express their personal opinion on the status of the research under review.
About Expert Opinion
For over a decade, the Expert Opinion series has provided systematic and authoritative reviews to support every stage of the drug discovery and R&D pipeline from target to market. Each of the nine journals in the series covers a specific aspect of the pharmaceutical pipeline.
The series contains the following journals: Expert Opinion on Biological Therapy, Expert Opinion on Drug Metabolism & Toxicology, Expert Opinion on Drug Safety, Expert Opinion on Emerging Drugs, Expert Opinion on Investigational Drugs, Expert Opinion on Pharmacotherapy, Expert Opinion on Therapeutic Patents, and Expert Opinion on Therapeutic Targets.
New for June 2006 - Expert Opinion on Drug Discovery
This new addition to the Expert Opinion range will focus on drug discovery in the post-genomic era, with particular emphasis on the technologies and disciplines involved; assay development, modelling, in silico drug design and informatics.

Genetics Plays Role in Side Effects Associated With Painkillers

A study published in the January issue of the American Gastroenterological Association (AGA) journal Gastroenterology found a difference in how people responded to popular painkillers and that up to 30 percent of this variability can be attributed to an individual’s genetic makeup. This variation can influence both how useful the drugs are in affording relief from pain and inflammation, and the number and severity of the adverse effects. This evaluation is perhaps the most rigorous look at how people vary in their response to drugs and was designed as part of a strategy to determine genetic and other markers that might help predict response and safety of these drugs, including susceptibility to cardiovascular complications.
The study looked at people taking two popular painkillers --rofecoxib (Vioxx, Merck) and celecoxib (Celebrex, Pfizer) -- known as COX-2 inhibitors. During the past two years, evidence has emerged that COX-2s confer a risk of heart attack and stroke, resulting in two of the drugs in this class being withdrawn from the market and a black box warning being issued for a third drug.
“The use of any drug involves a mix of benefits and risks. The problems with COX-2 inhibitors were real, but involved less than 2 percent of patients who were taking them,” said Garret A. FitzGerald, MD, study author from the University of Pennsylvania School of Medicine. “Because we often underestimate just how much people differ in their response to the same dose of the same drug, there is a need to develop diagnostic methods to identify those patients at an increased risk of cardiovascular events and explore this variability in drug response to move toward an individualized approach in drug development.”
Researchers at the University of Pennsylvania examined the variability, both within and between subjects, in response to celecoxib and rofecoxib, in a randomized, double-blind, placebo controlled study. Screening, enrollment and follow-up of healthy study volunteers was performed between January 2002 and January 2004. The study was conducted on 50 healthy volunteers between the ages of 21 and 43 years old who received a single dose of placebo, celecoxib and rofecoxib in random order. This was done to allow researchers a direct comparison of the responses to the drugs within the same subjects. Five of the patients went through the entire protocol five times to assess variability within individuals.
According to study authors, different factors in the environment result in a variety of responses from an individual who is dosed with the same drug at different times. This effect is seen even when as many variables as possible are standardized or controlled for. Approximately 30 percent of the variability found in patients was attributable to differences between individuals, suggesting the contribution of genetics to a variety of biomarkers of drug response. The study also illustrates that even healthy individuals without a recognized risk of disease respond quite differently to the drugs.
Previous studies have shown that rofecoxib and celecoxib result in a small number of the people who were apparently at a low-risk of cardiovascular disease initially, proceeding to increase that risk to the point that culminates in heart attack and stroke following prolonged use of these drugs. According to researchers, exploiting this variability could permit management of the cardiovascular risk of COX-2 inhibitors, while preserving their efficacy for patients most likely to benefit from them and determining how these drugs might be administered to people initially at low risk for cardiovascular disease.
“Typically when a drug causes hazardous side effects, the reaction is to suggest that people reduce the dosage they are taking. However, this has often been followed by withdrawal of the drug from the market when the problems are not eliminated,” said FitzGerald. “These findings highlight that while a lower dose may reduce the likelihood of problems on average, it will not eliminate them on an individual level because there is such a marked variability in how each person reacts to these drugs based on their genetic makeup.”
Study authors are hopeful that this work will provide an impetus for the development of a science-based approach to risk management. Exploitation of variability in response can lead to tests that identify patients most likely to benefit or suffer from harmful side effects caused by these drugs. “This study provides a starting point for the development of diagnostics that allow the medical and research communities to conserve benefits while managing the risks of COX-2 inhibitors,” said FitzGerald.
About the AGAThe American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology.
About Gastroenterology Gastroenterology, the official journal of the AGA, is the most prominent journal in the subspecialty and is in the top one percent of indexed medical journals internationally.
Source: American Gastroenterological Association

Truth in advertising; service packaging; 'tingi' marketing

QUESTION: If consumer perception is the primary basis for getting people to buy products and services, does this mean that truth in advertising is irrelevant in marketing?
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Answer: On the contrary, what this means is that marketers ought to be extra careful in using consumer perception to motivate consumers through advertising.
As a marketer, you can use consumer perceptions for good or bad. Truth in advertising is good. Deception is bad. You can get away with it at first, but it won't last.
Consumers will, sooner or later, find out that they've been fooled. As Abraham Lincoln said: "You can fool some of the people some of the time. But you can't fool all of the people all the time."
Deception, of course, includes cases of keeping quiet about what you know may harm consumers. That's a case of withholding "truth."
Take the case of Merck's Vioxx, the acute pain killer and anti-arthritis medication that had to be withdrawn from the market because Merck, or more precisely its medical researchers, withheld from publication in the New England Journal of Medicine knowledge of three heart attacks among Vioxx's patients participating in the large scale clinical study of Vioxx.
The heart attacks took place in the final five weeks of the trial study. The patients who had the heart attack were supposedly at low risk for heart problems.
But this was not the only thing the Merck researchers withheld. The study had apparently found "more cardiovascular problems potentially connected to Vioxx."
These problems were not reported in the published study. Such withholding of knowledge is highly unethical and a serious breach of the Hippocratic oath.
In pharmaceutical marketing, published clinical studies are a powerful "advertising" material for persuading doctors, such that withholding knowledge of the three heart attacks and the connection to more cardiovascular problems violated the truth in advertising maxim.
Question: Your column mentioned that the consumers' first physical contact with a consumer product is not with the product itself, but the packaging. That's why you said it's critical to give packaging more than the passing attention it's given. How about in the case of services? Where is the first physical contact?
Answer: Think of consumer goods packaging as the product's tangible presentation at point of purchase. So let's rephrase your question into: "For a service, what is the tangible presentation at point of purchase?"
We've written before that a service is intangible. To give it a tangible presentation, you need (in the words of Ted Levitt of Harvard) to "tangibilize its intangibles." How do you do that?
Experts in service marketing say that service is presented to customers through three things: (1) a satisfying service staff, (2) a satisfying service venue, and (3) a satisfying service processing.
So there you are. A service packaging has three dimensions that you must all satisfy simultaneously.
It is because of this inseparable, multi-dimensional character of services that marketers like to say that service marketing is much more difficult than consumer goods marketing.
Notice that one of the three dimensions of service packaging involves a human being. That's not at all easy to control in terms of consistent quality.
Question: In "tingi" marketing, or low-unit pack/sachet marketing, how do you determine the right size to offer?
Answer: This is one of those marketing problems where you cannot go wrong if you go by the "marketing concept."
It's that concept that says: "Always start from where your consumers are and never from where you (as marketers) are." So find out what your target consumers' preference is. Or look around for a benchmark. Consider, for example, shampoo.
The size of its sachet is a single-use amount for its target consumer, the amount of which has been validated by a product test.
Or take cheddar cheese, the low unit pack of which is a single slice.
The size and thinness was determined largely by moms of school kids bringing cheese sandwiches.
Or take the latest mega users of "tingi," namely, Smart Communications Inc. (which pioneered it) and Globe Telecom Inc. (which followed suit after six months).
Both of these marketers have applied the low unit pack on SMS, the phone's so-called "killer application" and its "pasa load."
That "pasa" [transfer] load's tingi started with P5 and based on continuing consumer demand, has now gone down to the unbelievable pasa load amount of P2!
So the key to answering your question are your target consumers. Consult them. Learn from them.

Merck Vioxx Judge Threatens to End Suit Consolidation (Update2)

The judge overseeing federal lawsuits over Merck & Co.'s Vioxx painkiller said he may end his effort to combine the cases for a possible settlement because of delays in getting some claims to trial.
U.S. District Judge Eldon Fallon in New Orleans said he is having trouble getting jury trials scheduled after Hurricane Katrina displaced thousands of residents and shut the city's courthouses for months. Plaintiffs' lawyers are pressing ahead with similar Vioxx suits in state courts around the U.S.
Fallon, at a Jan. 3 hearing, said he may ``shut down'' the consolidation ``if all the cases are being tried in state court before we get one tried in federal court.''
The judge said he will consider sending all federal Vioxx cases back to their home states for trial, a move that would make it more difficult to negotiate an overarching settlement. Merck, the third-largest U.S. drugmaker, has refused to pursue a settlement and instead set aside $675 million to fight suits over claims that Vioxx caused heart attacks or strokes.
``Judge Fallon is trying to make the point that he wants to see the federal litigation stay on track,'' said Ted Mayer, a lawyer with New York's Hughes Hubbard & Reed who represents Merck. ``The only way to do that is to press forward with getting cases to trial.''
Test Cases
Fallon said in October he wanted to try some Vioxx claims before starting settlement talks. Fallon had set three federal cases for trial in the first four months of this year, with plans to use the verdicts to help set values for other Vioxx claims.
``They were supposed to be test cases,'' said Chris Seeger, a New York lawyer with the firm of Seeger Weiss and a member of a steering committee overseeing the federal cases. ``If Judge Fallon can't try them, then his only choice is to get them ready for trial and farm them back out.''
Six Vioxx suits are set for trial in state courts in New Jersey, Texas, Florida and California over the next six months, Fallon said. Getting the same number of federal cases scheduled in New Orleans in the period will be difficult because of the devastation wreaked by the August storm and floods, he said.
``The witnesses are not available, the lawyers are not available, the records are not available and the doctors are not available,'' Fallon said.
Merck, based in Whitehouse Station, New Jersey, pulled Vioxx off the market in September 2004 after studies linked it to increased heart risks for long-term users. In February, a panel ordered all federal Vioxx suits consolidated in Fallon's court for pre-trial proceedings. Judges sometimes use consolidations to push for settlements in product-liability cases.
Split Verdicts
Merck's shares fell 31 cents to $32.87 in after-hours trading and have fallen more than 26 percent since Vioxx's withdrawal. The drug generated $2.5 billion in sales in 2004.
Fallon has estimated the company may have to defend more than 100,000 Vioxx suits. Merck's liability may reach $50 billion, Friedman Billings Ramsey analyst David Moskowitz estimates.
The company split the first three cases tried over the painkiller. In August, a Texas state court jury ordered Merck to pay $253 million to the family of a Wal-Mart manager who died of heart problems after taking Vioxx for about eight months.
A state jury in Atlantic City, New Jersey ruled in November that Merck wasn't responsible for the heart attack of a postal worker who took the drug for about two months. In December, a federal jury in Houston deadlocked over whether a Florida man's use of the drug for about a month led to his fatal heart attack. The case is set to be tried again in February.
Mark Lanier, a Houston attorney who won the first Vioxx verdict against Merck, said the company's vow to try all suits over the painkiller is forcing plaintiffs' lawyers to pursue state court trials. Lanier is set to try the next one, in New Jersey starting Feb. 27.
``I have 2,000 Vioxx cases that I need to get to trial,'' Lanier said. ``If there are problems with getting them tried in federal court, I have to move forward in all possible courts.''