big pharma

Whenever you read about some high profile drug company trial where the smoking gun is some incriminating email, do you shake your head and wonder, "How could they have written that in an email?" There are two ways for a drug company to protect itself from being nailed by these kinds of emails. The best is not to do things that if written anywhere would incriminate them. The other way is to teach your employees not to leave documentary evidence of your company's misdeeds. Guess which route the drug companies are taking? Want to avoid those embarrassing internal emails containing concerns that…
So what does heartburn have to do with diabetes? Funny you should ask. Big Pharma giant AstraZeneca is being sued by 15,000 people who claim that their atypical antipsychotic, Seroquel, causes diabetes. Seroquel is approved for bipolar disorder, but unless there are a lot more people with bipolar disorder than we know, it is clearly being use off label because it is AstraZeneca's second best selling drug. What's the best seller, at least for now? The heartburn/ulcer drug, Nexium: Seroquel, used to treat bipolar disorder, brought in $4.03 billion last year, making it AstraZeneca's second-…
The tort system is the favorite whipping boy of the anti-regulation crowd. That's because once you remove regulation, something the Bush administration has championed and done effectively, the only recourse someone injured by the fraud or negligence of a product or drug manufacturer is through a lawsuit for damages. Since the anti-regulation crowd serves Big Pharma and their cronies, this is the perfect solution: no constraints. The propaganda machine, aided an abetter by a compliant congress and a business dominated media, has been extremely successful in promoting the idea that tort suits…
We've had occasion to discuss the boondoggle, Project Bioshield a number of times (here, here, here, here, here, here, here, here). Maybe I should have said, quite a number of times. REally, though, it's hardly worth mentioning. Via the Clinician's Biosecurity Briefing, this: The Project BioShield Act, passed in 2004, gives HHS "authorities to expedite research, development, acquisition, and availability of priority medical countermeasures for public health emergencies caused by terrorist attacks." This Congressionally mandated report covers progress on the uses of those authorities for the…
Most academic scientists -- including me and my colleagues -- don't want unnecessary federal interference with what we do. We're like any regulated community. Not happy to be regulated. Unfortunately we have made the unnecessary necessary by allowing improper conflicts of interest to infest academic medicine and predictably, Congress is about to step in. Until now, the academic response to periodic external scrutiny of potential research conflicts has been increasingly to assert that it can police itself. In 2001, the Association of American Medical Colleges issued recommendations for strong…
So Roche Pharmaceuticals now has sufficient productive capacity to make their influenza antiviral Tamiflu (oseltamivir) meet demand. More than enough, it appears, since they now have come up with a new scheme to unload some of their inventory before its 3 year shelf life expires and to keep turning over the inventory year after year, whether or not there is a demand in any particular year: With an endorsement from US health officials, Roche, maker of the antiviral drug oseltamivir (Tamiflu), today unveiled a program to encourage more businesses to stockpile the drug to protect employees in…
There is a great deal of activity on the bird flu vaccine front. Several different new techniques to make vaccines are being tested and so are additives to vaccines, called adjuvants, that boost the ability of the preparation to induce the body to make sufficient antibodies to protect us against infection. The smaller the dose needed for protection, the more people can be vaccinated for a given amount of production. Since we are talking about enough productive capacity to vaccinate a significant proportion of the world's population in the event of a catastrophic pandemic, this is obviously a…
Since we don't do much health services posting around here I sometimes forget how terrific the blog Health Care Renewal is. It's always interesting. Sometimes it brushes against things we are concerned about here and last week there was a post with some good links about GlaxoSmithKline, a Big Pharma company active in influenza antivirals (Relenza) and pandemic vaccines. The companies of Big Pharma represent some of the most profitable on earth, making so much money that normal rates of profit, like what you might get from defense contracting, are considered failure. They justify their obscene…
I haven't posted on the vaccine/autism question for several reasons. It is quite well covered by other science bloggers, it tends to generate more heat than light, and we didn't have anything new to say. I have on several occasions discussed it with two of the world's top experts on the health effects of mercury and one of the world's top autism experts. None of the three felt there was a vaccine-mercury connection to autism. But news that the US government was going to include vaccine critics in shaping national vaccine policy made me change my mind about posting. I won't be addressing the…
US Secretary of Health and Human Services, Michael Leavitt, is in Indonesia to discuss matters of mutual interest with the Indonesian government. Topic number one was the Indonesian government's opt out of the international influenza surveillance system which has been in place for almost 60 years and provides vital information on what flu strains to include in the next year's seasonal flu shots. But the system is not limited to seasonal influenza and is an important part of the global surveillance of all influenza viruses that might be of human health concern, chiefly among the non-seasonal…
While we are all waiting for the other shoe to drop and a nasty, rip roaring flu pandemic to come rushing down the tracks at us, lots of companies have jumped into the pandemic vaccine sweepstakes. Reuters reports that at least 16 companies are testing flu vaccines and probably even more are involved in some technical aspect of vaccine production. That's good, although whether it will make any significant difference except around the margins remains to be seen. Timing is everything. Meanwhile, though, work is going forward on many vaccine fronts. The one to hit the PR wires today is a report…
Sometimes when I surf the net looking for things to write about I run across things I don't ordinarily write about but attract my attention because they are especially pertinent to my own health. Here's an example. I recently herniated a disk, for which I took fairly hefty doses of anti-inflammatories. Mostly it was extra strength aspirin but often it was horse doses of ibuprofen. I am also of the age that it makes sense to take low dose aspirin for its anti-platelet effects. There is good data to suggest this is a preventative for heart attack and stroke. Now it turns out I may have been…
I'm away from home and I did something really, really bad to my back. I could hardly tie my boots this morning (boots needed; it is snowing like stink up here). One of my fellow scientists took one look at me and said, "I guess you need some Vioxx." Then he laughed. Since I hardly know this person I don't think he was trying to kill me -- he wouldn't have laughed, then, I'm guessing. But Vioxx has killed some other people before the FDA finally acknowledged it could do that. They were soundly (and appropriately) criticized for keeping too quiet. Now, it seems, some are complaining because…
The US Food and Drug Administration (FDA) doesn't want Americans to buy legal pharmaceutical products from Canada where the identical drug is considerably cheaper because the imported drug might not be safe. Those unreliable Canadians. Better to pay top dollar for heparin from the American subsidiary of a Big Pharma multinational, Baxter Healthcare. Except that the active ingredient in Baxter's intravenous heparin came from China. From an uninspected plant. And there was indeed a safety problem: More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007,…
A lot of things that seem on first glance to be "news" are really just reprints or slight edits of press releases written to tout a commercial product. This is also true of "Newsletters" that charge money for inside news. Datamonitor is a company that claims to be "the world's leading provider of online data, analytic and forecasting platforms for key vertical sectors. We help 5,000 of the world's largest companies profit from better, more timely decisions" (Datamonitor website). Some of the stuff they give away, since I see it and I don't subscribe to anything they sell. But based on its…
There is a class of legal cases that are so blatant lawyers call them Oh My God cases, you know, the kind when you see the facts you say, "Oh my God" (NB: don't give me grief because I'm an atheist. I'm allowed to use colloquial phrases that have their origins in myth and superstition). Back to the subject. I'm a journal editor and also a frequent peer reviewer of scientific articles for other journals (I'm procrastinating reviewing three of them by writing this post). And in that context, I'd call this story an Oh my God story: A peer reviewer leaked a paper due to appear in The New England…
A report late last night by Helen Branswell alerted me to a tabulation from a new tracking system WHO is putting into place to answer demands from a number of member states in the developing world that there be more transparency in how isolates of avian influenza (bird flu) submitted to WHO are used and by whom. About a third of confirmed cases have been registered in Indonesia, although that country has provided less than a quarter of the isolates, a reflection of the refusal by the country's health minister, Dr. Siti Fadilah Supari, to provide any more specimens until matters of vaccine…
We've discussed the scandal over the use of Avastin and Lucentis for wet macular degeneration several times (here, here, here). If you've missed it, here's the gist. Avastin is a drug approved to treat colon cancer. It works by choking off blood vessels to the tumor. It turns out, however, that a tiny dose of the same drug, when injected into the eye can also stop the uncontrolled growth of blood vessels behind the retina that produces a leading cause of blindness in the elderly, macular degeneration. The good news is a compounding pharmacy can take the large dose in the Avastin package and…
Indonesian Health Minister, Siti Fadilah Supari, has reiterated her refusal to share isolates of H5N1 virus (it's unclear if this is her decision alone or is the considered decision of the Indonesian government). This came at the current inter-minsterial conference on bird flu on underway in Delhi (how many of these conferences are there, anyway? It seems like every week there's another one.) Her demand is that every isolate have a Material Transfer Agreement (MTA) requiring a statement each time the isolate is shared with another laboratory, stating it is only for diagnostic purposes and not…
If you need the antibiotic ciprofloxacin ("cipro") (famous for its use as prophylactic agent for those potentially exposed to weaponized anthrax in 2001), I know where you can find a lot of it. In Patancheru, India, near Hyderabad, one of the world's centers for production of generic drugs. Most of the cipro made there is shipped out, but it turns out a lot of cipro stays behind, in the sewage of Patancheru. A paper by Larsson et al. (Journal of Hazardous Materials 148 (2007) 751-755; hat tip SusieF) found the highest levels in sewage effluent of pharmaceuticals of any yet reported. The…