VentureBeat

I’m at work on a longer post that hasn’t yet come together, so I thought I’d pull an old dodge favored by daily newspaper columnists and respond to some reader comments instead. Fortunately for me, both comments left here in the past day or so have been thought-provoking — maybe there’s hope for the Internet after all.

With respect to the tussle over patents and drug pricing in Thailand, Gal Josefsberg wrote:

I’m not sure how they expect to get cheap HIV drugs if the destroy the company’s profits. I know we all think these sort of drugs should be cheap, but there’s an enormous cost to developing and testing them. Without some kind of profit motive, the R&D spent on these treatments will go down. I’m not saying the pharma companies should gouge HIV patients, but just saying “thanks for developing this drug, we’ll take it from here” is not the right answer.

Where AIDS drugs in the developing world are concerned, the arguments tend to be a little more complicated than I may have suggested. Some pharma and biotech companies — I’m most familiar with Gilead Sciences, although I believe others do this as well — explicitly acknowledge that it’s wrong to profit from the world’s poorest nations and set what they call “no-profit” prices for HIV drugs in almost 100 countries. Of course, they still plan to make out handsomely in the U.S., Europe and other industrialized parts of the world.

Things, however, get quite a bit murkier in “middle income” nations like Thailand, where the population as a whole is unquestionably getting richer, but where many of the people who need the drugs most are also still quite poor. Critics argue that it’s the responsibility of the Thai government to help its citizens afford drugs, and while they have a point, I’m not convinced the drug companies are wholly blameless. Many of them have only grudgingly begun efforts to cut poorer nations some slack on the price of life-saving drugs, following years of protest by AIDS activists and international organizations. Given that many activists still think companies like Abbott are trying to profiteer in developing-but-not-exactly-wealthy nations like Thailand, it’s no wonder that distrust of the pharmas still runs high in many quarters.

By the way, Brazil has apparently issued a similar threat to Merck over its HIV drug efavirenz (via Pharmalot).

In response to an item on the tactics drug reps use to push their product on doctors, RJ notes:

the first paper seems to be describing a phenomenon known as “sales”– truly a beauty to behold when it’s done well. No matter whether you’re selling drugs or enterprise software. That’s why the great sales people are paid so much. They’re artists.

That paper was written so vividly that I couldn’t help but wonder if Ahari, the former Lilly rep, doesn’t kind of miss his old job for exactly those reasons. There’s definitely something awe-inspiring about watching a professional salesperson at work, although I’d feel better about admiring it here if the sales job wasn’t specifically designed to override a physician’s best medical judgment — which is, after all, what the patient needs most and what insurers are supposed to be paying for.

Arm wrestling over drug patents – Three months ago, the military government running Thailand informed Abbott Laboratories that it intended to break the company’s patents on several expensive drugs, including the HIV protease inhibitor Kaletra, thus allowing the manufacture or import of cheaper knockoffs. Abbott responded by dropping its plans to bring newer drugs, including a heat-resistant version of Kaletra, to Thailand, and the pharma and the junta have been locked in a standoff ever since. Over the weekend, Abbott offered to make the new version of Kaletra available at a deep discount price if Thailand left its patents alone; so far the government hasn’t responded.

The issue is a serious one for drug companies, including the handful of biotechs — among them, Gilead Sciences and Vertex Pharmaceuticals — who make or hope to launch drugs against developing-world scourges such as HIV and hepatitis. Years of high-handed behavior on the part of Big Pharma have fueled a militant backlash in poorer nations against the makers of high-priced, life-saving drugs. The Wall Street Journal has an in-depth look at the issue today. Here’s an excerpt:

Global drug makers are increasingly looking to emerging markets to compensate for slowing growth in the U.S., Europe and Japan. Abbott’s troubles in Thailand suggest that cracking the new markets can be tough because governments are driving a hard bargain on price. They are using the threat of breaking patents to get good deals. Thailand has won the support of nonprofit groups and world organizations while meeting little resistance from the U.S. government….

A number of emerging nations are working on plans to slash drug costs. Lawmakers in the Philippines are debating legislation that would permit breaking patents in certain circumstances and allow the country to use more generic drugs to fight AIDS and potential pandemics. Kenya is considering breaking patents as Dr. Mongkol has done to open the door to cheaper copies.

In an interview last week, Indonesia’s U.S.-educated trade minister, Mari Elka Pangestu, said her country might introduce price caps to bring the price of branded drugs closer to the level of generic equivalents. “The difference in price between nongenerics and generics is perceived to be too high,” Ms. Pangestu said.

Such moves could threaten the ambitions of drug companies in developing nations — especially those such as Thailand that are growing wealthier. While the U.S., Europe and Japan account for the vast majority of sales at big Western drug makers, their growth is slowing. The U.S. this year will contribute about 36% of total growth in pharmaceutical sales, down from 54% five years ago, according to a forecast by IMS Health, a research and consulting firm.

Heart problems in the elementary-school set – Another WSJ story chronicles a previously overlooked angle to the obesity debate: Kids as young as ten are turning up with early signs of heart disease. The finding emerged by accident when researchers enrolled 50 seemingly healthy kids in a clinical trial, only to find via echocardiogram that several had enlarged hearts — a condition known as left ventricular hypertrophy. LVH is typically associated with a high body mass index, but doctors apparently hadn’t even noticed that these kids were overweight, quite possibly because they see so many heavy children that their mental picture of “average” was skewed.

Fear and loathing among biomedical researchers – Earlier this decade, a sustained push to boost biomedical research doubled the NIH budget in five years. Now, however, the unintended consequences of that rapid increase are coming home to roost. This news story in Science lays out the basic problem: Big budgets attracted more scientists and led universities to build bigger and larger labs, but now that demand for research money is higher, budgets are flat, leaving less to go around. For a personal take on the situation, check out this post from “Orac,” a pseudonymous surgeon/scientist at Respectful Insolence.

Google your health records? – Biotech/pharma consultant David Williams, blogging from the World Health Care Conference in Washington, reports on a speech by Google’s Adam Bosworth and thinks a Google healthcare initiative might not be that far off. (A quick glossary for anyone clicking through to Williams’ acronym-heavy post: EHR stands for “electronic health record,” while PHR means “personal health record” — the distinction, apparently, being that an EHR is maintained by a health-care provider, while a PHR is owned and updated by the patient. If you want to know more, try this explanation. PBM, meanwhile, stands for “pharmacy benefit manager” — it’s essentially a catch-all phrase for pharmacy chains and other companies that manage the business of buying drugs and filling prescriptions. Aren’t you sorry you asked?)

EHR SNAFU – Yet another WSJ story today outlines the technical problems Kaiser Permanente has experienced as it tried to roll out an electronic-records system — while, of course, squelching a whistleblower who sought to draw attention to the issue. Merrill Goozner, who’s also at the World Health Care Forum, has more on the subject of electronic records and how they might — and might not — encourage competition among doctors here and here.

AstraZeneca chief acknowledges drug-promotion issue – According to this article in The Independent, AstraZeneca CEO David Brennan has acknowledged the possibility that his sales reps may have been improperly promoting the company’s chemotherapy drug Arimidex, and suggests that the issue is under internal investigation. (Hat tip: Peter Rost.)

Two fascinating papers in the open-access journal PLoS Medicine turn a spotlight on the practice of “detailing” — the office visits that drug-industry salespeople use to flatter and manipulate their way into the good graces of the doctors they want to influence.

The first and most eye-opening paper is co-authored by Shahram Ahari, a former Eli Lilly sales rep, and Adriane Fugh-Berman, a Georgetown University professor who researches drug marketing. Together, the two outline a variety of tactics that sales reps use on detail visits to disarm doctors and to indirectly — sometimes all but imperceptibly — nudge them into prescribing their company’s drugs more freely. This is one of those papers that best speaks for itself, so I’ve excerpted some key passages below. For the full effect, though, read the whole paper; Table 1 alone is worth the price of admission.

Good details are dynamic; the best reps tailor their messages constantly according to their client’s reaction. A friendly physician makes the rep’s job easy, because the rep can use the “friendship” to request favors, in the form of prescriptions. Physicians who view the relationship as a straightforward goods-for-prescriptions exchange are dealt with in a businesslike manner. Skeptical doctors who favor evidence over charm are approached respectfully, supplied with reprints from the medical literature, and wooed as teachers. Physicians who refuse to see reps are detailed by proxy; their staff is dined and flattered in hopes that they will act as emissaries for a rep’s messages. (See Table 1 for specific tactics used to manipulate physicians.) [...]

The purpose of supplying drug samples is to gain entry into doctors’ offices, and to habituate physicians to prescribing targeted drugs. Physicians appreciate samples, which can be used to start therapy immediately, test tolerance to a new drug, or reduce the total cost of a prescription. Even physicians who refuse to see drug reps usually want samples (these docs are denigrated as “samplegrabbers”). Patients like samples too; it’s nice to get a little present from the doctor. Samples also double as unacknowledged gifts to physicians and their staff. The convenience of an in-house pharmacy increases loyalty to both the reps and the drugs they represent….

Pharmaceutical companies spend billions of dollars annually to ensure that physicians most susceptible to marketing prescribe the most expensive, most promoted drugs to the most people possible. The foundation of this influence is a sales force of 100,000 drug reps that
provides rationed doses of samples, gifts, services, and flattery to a subset of physicians. If detailing were an educational service, it would be provided to all physicians, not just those who affect market share…. Physicians are susceptible to corporate influence because they are overworked, overwhelmed with information and paperwork, and feel underappreciated. Cheerful and charming, bearing food and gifts, drug reps provide respite and sympathy; they appreciate how hard doctor’s lives are, and seem only to want to ease their burdens.

The second paper isn’t anywhere near so colorful, but compensates with depth of analysis. A research team at the University of California, San Francisco, studied market-research forms for the anti-seizure drug Neurontin (generically known as gabapentin), which became public as the result of a whistleblower lawsuit against Neurontin’s maker, Pfizer. That lawsuit contended that the former Parke-Davis — later acquired by Pfizer — had violated federal rules by promoting Neurontin outside its FDA-approved uses, and concluded with a $430 million out-of-court settlement.

By studying 116 of the market-research forms filled out by selected doctors following a sales rep visit — here’s an example:

– the researchers built a detailed picture of the way Neurontin detailing worked. In 44 percent of the visits, physicians reported at least one “off-label” message related to Neurontin use in an unapproved fashion — exactly the sort of thing sales reps are forbidden to introduce in such conversations. Almost a full quarter of the visits involved only discussion of unapproved uses of the drug. (The researchers acknowledge that they have no way to know if the sales reps initiated such conversations.) Ultimately, almost half of the doctors involved said they planned to increase their prescription of the drug following the visits, while none reported plans to decrease Neurontin use.

Interestingly enough, former Pfizer exec Peter Rost is now closely tracking what may be a similar scandal related to AstraZeneca’s promotion of its chemotherapy drug Arimidex. The story, which began with the firing of an AstraZeneca regional sales manager who compared doctors’ offices to “a big bucket of money” in an internal newsletter, then mushoomed to include a cabal of alleged whisteblowers and leaked audio recordings — supposedly of AstraZeneca sales-rep training sessions — is detailed at his sometimes quirky blog Question Authority. If you don’t mind working backward, start here and keep scrolling down. Way, way down if you want to get all the way to the beginning — Rost is nothing if not prolific.