Category — Pharmaceuticals

Richard Fine and Nathan Frank “are doing for generic drugs what American Apparel did for plain T-shirts,” reports David Sax in Bloomberg Businessweek (3/26/12). Their pharmaceutical startup Help Remedies, is wrapping generics “in cool with every trick in the downtown branding playbook, from hip packaging to absurdist videos to youth targeting.” Their premise is that most store-bought remedies are too complicated and their packaging too confusing. “Excedrin sometimes has three or four drugs just for a headache,” says Richard. “These companies mix a load of drugs, put on racing stripes, and wrap them in packages that are very confusing.”

Help Remedies instead cuts “through the confusion by offering single-ingredient drugs in low doses, with clear, symptomatic titles, such as ‘Help: I Have a Headache‘ (acetaminophen) or ‘Help: I Have a Stuffy Nose‘ (phenylephrine).” The idea, according to Help’s creative director, is to “sell the medicine as though it was coming from a friend, not a doctor in a lab coat.” The brand’s marketing materials are worded “in the first person” and the packaging is a “simple white, biodegradable carton.” The pills have “no colors or coatings.” Jim Butschli of Healthcare Packaging magazine, says the simplified approach aligns with “the reason the consumer is shopping in the medication aisle in the first place.”

Humor is a big part of the pitch: “On the back of Help’s nausea medicine, the package jokes about how the pills are flavorless: ‘We were going to make them deviled-egg flavor, but then we thought it might defeat the purpose.’” Help is also going for unconventional distribution, such as hip-hotel mini-bars. However, Richard Meyer, a consultant, is skeptical, noting that Help’s youth-oriented target audience “happens to be the least brand-loyal of all drug consumers.” Founded in 2008, Help reported sales of $4 million in 2011 (a 1,000% increase from the previous year) and projects sales of $15 million in 2013. The company is not yet profitable, although it has disribution through Target and Walgreens, is expanding into Canada, and plans to augment its product line this summer.

"We wanted to get out of what I called 19th-century drug development — give a drug and hope it does something," says Dr. William Potter of Eli Lily in a New York Times piece by Gina Kolata (8/12/10). "What was needed was some way of seeing what was happening in the brain as Alzheimer’s progressed and asking if experimental drugs could alter that progression." One problem was that no single researcher or company could do that alone, as it required tracking some 800 subjects, looking for "biomarkers" of the disease’s progression, for years.

An even bigger problem was that it would require scientists to share data. "It’s not science the way most of us have practiced it in our careers," says John Q. Trojanowski of the University of Pennsylvania. "But we all realized that we would never get biomarkers unless all of us parked our egos and intellectual-property noses outside the door and agreed that all of our data would be public immediately." Even if that meant that "anyone could use it, publish papers, maybe even misinterpret it and publish information that was wrong."

This collaborative approach, known as ADNI, has so far attracted "more than 3,200 downloads of the entire massive data set and almost a million downloads of the data sets containing images from brain scans." Most important, "the effort is bearing fruit with a wealth of scientific papers on the early diagnosis of Alzheimer’s using methods like PET scans and tests of spinal fluid (link). More than 100 studies are under way to test drugs that might slow or stop the disease." A similar approach is now also being used to fight Parkinson’s disease.

Growing numbers of doctors are banning the free drug-samples that have been a mainstay of prescription-medication marketing, reports Rita Rubin in USA Today (12/1/08). ” Doctors think they’re saving their patients money and helping them by giving out free medication,” says Dr. David Miller of the Wake Forest University School of Medicine. In fact, he says “they are likely to be costing those patients more money down the road.” The problem, he says is that the samples tend to push doctors to prescribe more expensive, brand-name drugs, when cheaper generics would suffice.

Dr. Miller says he and his colleagues came to this conclusion after their offices moved to smaller quarters and had no room for a free-samples cabinet. “It was a great natural experiment,” he says. The result was that “doctors were three times more likely to prescribe less-expensive generics to uninsured patients after they lost the samples closet.” Proponents of the samples counter that the freebies are a boon to the needy and also enable patients to begin a course of treatment sooner. However, Dr. Adriane Fugh-Berman of Georgetown University Hospital says calls such arguments “a delusion, a rationalization.”

Dr. Peter Justis, one of 700 doctors at the Carolinas HealthCare System, where samples are now banned, says needy patients are instead issued a voucher redeemable for pills at a pharmacy. At the University of Pittsburgh Medical Center, doctors “can turn to the eSample Center,” an online service where doctors can order samples and have them shipped for free, giving doctors “a greater choice of samples.” According to a 2004 study, “drugmakers handed out free samples to U.S. doctors with a retail value of nearly $16 billion, equal to more than a quarter of their marketing budgets that year.” ~ Tim Manners, editor

GlaxoSmithKline and Ranbaxy Laboratories may be locked in a death match over generic knockoffs, but that isn’t stopping them from working together to find a cure for cancer, reports Peter Loftus in The Wall Street Journal (2/21/07). “Both friend and foe of the same company — that’s exactly right,” says Ranbaxy spokesman Charles Caprariello. The two companies are foes because Ranbaxy wants to start selling "copycat versions of blockbuster medications years before patents expire." Says Charles: "Our job is to challenge patents we feel are superfluous or not well grounded."

But they are friends because Glaxo wants to use Ranbaxy’s, low-cost "stable of scientists in India" to come up with "compounds to potentially treat infections, cancer" and other conditions. "In India they have some of the best chemists in the world," explains Glaxo ceo Jean-Pierre Garnier. But he adds: "Next to that is the generic division, whose sole purpose in life is to beat us up on patents, so we’re going to fight them."

As unlikely as this “love-hate” relationship sounds, it actually “embodies some paradoxical trends in the industry, and could signal a greater melding of branded and generic business models.” As Hussain Mooraj of AMR Research explains: "The opportunity for reinventing the relationship between branded pharmaceutical an generics companies, which has historically been very adversarial, is there," he says. The two companies actually have been working together since 2003, and Ranbaxy currently stands "to receive more than $100 million in potential milestone payments for products" they develop and Glaxo launches. ~ Tim Manners, editor

“Chinese and Western specialists approach pharmacology from very different angles,” but Novartis is hoping to find new cures by encouraging Sino-American collaborations, reports Nichcolas Zamiska in The Wall Street Journal (11/15/06). “For centuries, Chinese doctors have tinkered with different mixtures of medicines, guided in part by trial-and-error, to see which ones are the most effective. Working with that body of knowledge, they operate on the assumption that the traditional remedies work, even if by Western scientific standards it’s not completely clear why.” So, they know the cure works, but they don’t know which “target it hits.”

Western researchers, meanwhile, “often begin the search for a drug by identifying a target, and then looking for a chemical compound that has the desired effect. If they do find a drug that works, they usually understand the mechanisms behind it. That helps in refining the compound to make it more effective and in convincing regulatory authorities … that the medicine is safe and effective.” So, Novartis has hired a botanist named Shen Jingui of the Shanghai Institute of Materia Medica to venture into remote regions in areas such as China’s Xinjiang province, “to ferret out rare plants and herbs traditionally used in treatments for ailments ranging from aches and pains to cancer.”

Novartis hopes that if it can “isolate the particular compounds active in the Chinese traditional medicines by testing the raw extracts from the plants” Shen Jingui collects, the result will be “a new generation of blockbusters to fight diseases such as Alzheimer’s.” So far, Jingui “has provided around 1,000 natural products.” Of those, a total of nine “have shown particular promise against specific disease targets and two have been selected for further study.” Dr. Paul Herrling of Novartis says that hit rate is actually pretty good as compared to traditional research methods. The cost involved is also relatively small. He comments: "China has thousands of years’ experience of using plants in Chinese traditional medicines … why not use the Chinese experience as a kind of filter?" ~ Tim Manners, editor

“In one of the more unlikely collaborations of modern medicine, Britain’s largest children’s hospital has revamped its patient handoff techniques by copying the choreographed pit stops of Italy’s Formula One Ferrari Racing team,” reports Gutam Naik in The Wall Street Journal (11/14/06). The idea came to Dr. Allan Goldman, “head of the pediatric intensive care unit at Great Ormond Street Hospital,” a racing fan, while watching a Formula One race on tee-vee. He and a colleague, Dr. Martin Elliott, “noticed striking similarities between patient handovers at their hospital and the interchange of tasks at a racing pit stop.”

What they noticed was how well the pit crew handled its handovers — switching the tires, cleaning the air vents, adjusting the front wing, and sending the car on its way — in just seven seconds. Hospital handoffs “seemed downright clunky by comparison.” So, Drs. Goldman and Elliott “invited members of McLaren, a British team that fields race cars in Formula One contests, to provide insights into pit-stop maneuvers. Their interest was more in improving accuracy than improving speed, per se. Their primary discovery was this: “…. Pit-stop handovers were successful … because of an obsession with tiny mistakes.”

Everybody knows what the big problems are; it’s the cumulative effect of the small problems that nobody notices that can add up to “bad outcomes.” They also found that “each member of the Ferrari crew is required to do a specific job, in a specific sequence, and usually in silence. By contrast … the hospital handover was often chaotic." The doctors came up with a new, Ferrari-style protocol, and then compared a total of 50 handovers — half of which occurred before the Ferrari principles were applied and half after. The result: "… The average number of technical errors per handover fell 42 percent and information handover errors fell 49 percent." ~ Tim Manners, editor

Since the 1930s it’s been known that reducing “normal calorie intake by about a third” can “slow the biological forces of aging,” but only recently have scientists begun to claim that it’s possible to mimic the anti-aging effect with medicine, reports David Stipp in The Wall Street Journal (10/30/06). The reason calorie reduction (or CR) works is that our “genetic machinery evolved eons ago to enable survival through periods of food shortage … by retarding the rate of aging.” It’s a little complicated. But one Harvard scientist in particular, David Sinclair, says he’s already found “a substance in red wine called resveratrol” that creates the effect of CR, and its antiaging benefits, without actually reducing one’s caloric intake. So far, David has proved his concept by extending the life of yeast cells, fruit flies and roundworms. He’s now experimenting on mice.

Scientists in Italy, meanwhile, have used resveratrol to boost the life span of a certain short-lived fish by “more than 50 percent.” Before you uncork that bottle of red, be advised that you’d probably need to drink hundreds of glasses a day to get enough resveratrol to make a difference (and of course that would blow your diet, too). In addition, the scientific community is hardly lined up behind David Sinclair, with some of his own former M.I.T. colleagues suggesting that resveratrol is not the on-off switch to a longer, healthier life that he hopes it is. The F.D.A., meanwhile has no interest in “antiaging pills” per se, because it “doesn’t recognize aging as a problem warranting treatment.” However, if the drug is positioned as helping to prevent the ailments that can come with old age (diabetes, heart disease, Alzheimer’s, etc.) it could be a different story.

The big idea is that antiaging drugs could help people “stay in relatively good shape until a swift demise.” Experiments in CR in animals already have yielded some very attractive corpses. “Often it’s hard to identify the cause of death,” says one researcher. “The only apparent problem is that they died.” Starvation maybe? Anyway, one implication of all this is that our eating habits are not only making us fatter, but also older — obesity puts us in “fast-aging mode” (which may help explain why some girls today are hitting puberty by age eight). Another outcome is that David Sinclair has rounded up some $82 million in venture capital for Sirtris Pharmaceuticals, which he co-founded in 2004 to try to bring a resveratrol-based pill to market. In addition, the Glenn Foundation for Medical Research has kicked in between $75 million and $100 million to establish an antiaging institute, with David Sinclair as founding director. ~ Tim Manners, editor