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.)