VentureBeat

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.)

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Amgen’s anemia rollercoaster — Biotechnology titan Amgen may have dodged a bullet when a study released Thursday showed that its anemia drug Aranesp didn’t shorten the lives of patients, after several other studies had suggested the opposite. But its anemia franchise isn’t out of the woods yet. A Wednesday report in the Journal of the American Medical Association revealed that for-profit dialysis clinics prescribe far higher doses of anemia drugs to their patients than do their non-profit counterparts, suggesting a profit motive behind the overuse of drugs that have been linked to cardiovascular problems at high doses.

Now it appears that Congress may weigh in: The WSJ quotes Rep. Fortney “Pete” Stark, a California Democrat, calling for changes in Medicare reimbursement to eliminate any incentive to overuse the drugs, which stimulate production of the red blood cells that carry oxygen.

More on “generic” biologics — Here are two takes on the move to allow copycat versions of biotech drugs that I neglected to mention in yesterday’s post on the subject. Writing at Forbes.com, Scott Gottlieb — former FDA deputy commissioner for medical and scientific affairs, now a pundit at the neoconservative American Enterprise Institute — makes the counterintuitive argument that copycat biotech drugs will speed the development of new drugs, even if they’re just simply improved versions of older ones.

Meanwhile, pharma/biotech consultant David E. Williams dismisses the biogenerics push as “a bad bill that deserves to die” on his Health Business Blog, but suggests that Congress could adopt a more straightforward solution: Simply mandate price cuts on biotech drugs once their patents expire. It’s such a wacky but weirdly intriguing idea that I can’t even tell if it makes sense, but I certainly doubt that Congress could muster the political will for such a naked exercise of government power — it simply violates too many current assumptions about the usefulness and necessity of markets.

Stem cell divisions — The president of California’s $3 billion stem-cell research program resigned abruptly on Tuesday, citing both health concerns (a recent diagnosis of prostate cancer) and tensions between patient advocates and biomedical academics over plans to spend up to $300 million on new research facilities. Zach Hall’s departure will now come earlier than expected — he’ll depart at the end of April instead of the end of June — but plans to name a successor are already underway. Despite his title, Hall wasn’t the head honcho of the California institute; that honor is reserved for Robert Klein II, chairman of the inaptly named Independent Citizens Oversight Committee, who is also rumored to have clashed with Hall more than once. David Jensen of the estimable California Stem Cell Report has all the details.

Dollars for doctors (and everyone else) — Why does U.S. healthcare cost so much? The economics blog Marginal Revolution hosted a fascinating debate on the subject earlier this week, prompted by Tyler Cowen’s capsule review of a new book by Maggie Mahar titled Money Driven Medicine. The argument is too complex to do it much justice here; the best summary I can make without writing an essay myself is that the entrepreneurial instincts of doctors and medical-technology suppliers (including drug companies), combined with weak resistance from desperate patients, leads to market failure, including drastic overuse — and misuse — of medical services. Don’t miss Mahar’s contribution to the Marginal Revolution debate in comments. Two other takes on the book are here and here.

In a similar vein, this post from the group blog Health Care Renewal aims to explain why so many academic researchers seek out funding from pharmaceutical and biotech companies these days. Turns out it’s not just the greed of companies eager to co-opt paragons of the ivory tower; instead, blogger Roy Poses suggests that university incentives similar to the ones that motivate car salesmen are at fault. Definitely worth a read if the question has ever crossed your mind.

Research odds and ends from the week that was:
• Scientists discovered a gene that appears to be key to “self-renewal” in both embryonic and adult stem cells.

• Surgeons are exploring ways of conducting minimally invasive procedures using “natural openings” in the body such as the mouth, the rectum or the vagina.

• Take that, white supremacists: Physical anthropologists now believe that European skin only lightened up 6,000 to 12,000 years ago, suggesting that “our European ancestors were brown-skinned for tens of thousands of years” prior to that. The link is subscription-only, so here’s a brief snippet of the Science news article:

Researchers have disagreed for decades about an issue that is only skin-deep: How quickly did the first modern humans who swept into Europe acquire pale skin? Now a new report on the evolution of a gene for skin color suggests that Europeans lightened up quite recently, perhaps only 6000 to 12,000 years ago. This contradicts a long-standing hypothesis that modern humans in Europe grew paler about 40,000 years ago, as soon as they migrated into northern latitudes. Under darker skies, pale skin absorbs more sunlight than dark skin, allowing ultraviolet rays to produce more vitamin D for bone growth and calcium absorption. “The [evolution of] light skin occurred long after the arrival of modern humans in Europe,” molecular anthropologist Heather Norton of the University of Arizona, Tucson, said in her talk.