big pharma
revere | May 6, 2010Just because a company got it right once doesn't mean they'll get it right all the time. Back in the day, one of the great crisis management success stories was was Johnson & Johnson's handling of a case where someone intentionally introduced cynanide into on the shelf bottles of Tylenol in the fall of 1982 in the Chicago area. Seven people died. If you ever have trouble opening your over the counter or prescription drug bottles, you can thank the creep who did it -- whoever that is. No one was ever caught.
Here's a concise summary of the 1982 poisonings, courtesy Wikipedia:
Wednesday…
revere | April 16, 2010This was in the news a couple of weeks ago, but I held on to it so I could remind people of it again, the "too big to nail" syndrome":
Imagine being charged with a crime, but an imaginary friend takes the rap for you.
That is essentially what happened when Pfizer, the world's largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.
When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. "It sends a clear message" to the…
revere | March 15, 2010I've had occasion to remark a number of times how much of what is reported as "science news" is just warmed over press releases from university media departments or company flacks. I read them anyway, often sucked in my a headline that turns out to oversell the case. Now I'm becoming aware headlines can also (deliberately) undersell the case. Consider two press releases that came out on virtually the same day, one from Big Pharma Pfizer, the other from biotech player, Genentech, owned by Big Pharma's Roche (maker of Tamiflu). Pfizer, first.
The headline pretty much tells the whole story, as…
revere | December 23, 2009One of the most dismaying "features" (or is it a bug?) of the US government is the too cozy relationship of key agencies with industries they are either regulating, investigating or affecting in some ways. The revolving door syndrome perhaps reached its peak in the Bush II administration, but it's been a chronic problem going back decades or longer. Yesterday we learned of another example when Big Pharma giant Merck & Company issued a press release announcing it had hired Dr. Julie Gerberding (often referred to by CDC employees simply as "JLG"), the first female Director of CDC (hat tip…
revere | December 10, 2009The other day the British Medical Journal (BMJ) published a clutch of articles about whether Tamiflu was as useful a drug as some have touted. I read the main article, another one of the Cochrane Collaborative meta-analyses of the studies they deem useful about any particular subject, and it didn't seem to make much news. It confirmed what their previous review had said about the neuriminidase inhibitor antivirals for influenza (Tamiflu and Relenza): these drugs work but their effect is modest. We've been saying the same thing for years here, not because we did a fancy meta-analysis, but…
revere | November 23, 2009The US has ordered 250 million doses of swine flu vaccine, mainly from foreign manufacturers. That's a large proportion of the world's productive capacity. A couple of the biggest vaccine makers, Glaxo-SmithKline (GSK) and Sanofi Pasteur, have promised to make donations to WHO for use in the poorer countries and with some smaller donations that's maybe 160 million doses. Countries like the US that earlier had pledged 10% of their supply have yet to do so, and given the political problems of sending overseas vaccine when there's not enough for US citizens, well, good luck with that. So at best…
revere | November 7, 2009I first read Barbara Ehrenreich in 1971 when she wrote The American Health Empire: Power, Profits, and Politics with her (then) husband John Ehrenreich (Health PAC, 1971). She was by then a PhD in cell biology (Rockefeller University) and anti-war activist. We traveled in the same circles and I knew her slightly at the time. Her next book, Witches, Midwives, and Nurses: A History of Women Healers (with Deirdre English) was a new reading of women in medical history. It was an influential text in the emerging women's health movement. Since then she has published many books, several making the…
revere | August 7, 2009We've been rather kind to Senator Charles (Chuck) Grassley in the past. Yes, he's a right wing Republican with some really odious ideas, ideas for which he deserves to be criticized. But he's also been a champion of the Federal False Claims Act which has encouraged and protected whistleblowers to reveal how corporations have taken the taxpayer for a ride, something for which he deserves credit. Lately he has been on a tear about the ways Big Pharma has been buying influence with high profile medical professionals, with the direct implication that this has skewed their practice, their research…
revere | June 2, 2009Ten days ago Secretary of Health and Human Services Kathleen Sebelius announced that the US government was allocating $1 billion to help companies with production costs for a swine flu vaccine. Among the beneficiaries was French vaccine giant, Sanofi-Aventis, whose Sanofi Pasteur unit got a $190 million order. It was likely only the first in a series of expected orders for the company. Sanofi knows how to make vaccines. So what could go wrong?
Drugmaker Sanofi-Aventis has agreed to pay nearly $100 million to settle allegations it cheated Medicaid on the cost of nasal sprays.
The Justice…
revere | April 24, 2009As an academic epidemiologist I routinely do NIH funded research involving human subjects. That means my university must adhere to very strict regulations and guidelines for the protection of research subjects. Approval and monitoring of the ethical conduct of research funded by the Department of Health and Human Services (DHHS), of which NIH is a part, was made a legal requirement in the 1970s following widespread abuses, of which the Tuskeegee Syphilis Study and the experiments by Nazi doctors were the most notorious. But less flagrant ethical breeches were widespread in medical research. I…
sciencepunk | April 7, 2009
The Associated Press reports that lawyers working on a multi-billion dollar lawsuit against Pfizer are close to reaching a settlement.
Nigerian authorities allege that Pfizer conducted deadly drug experiments in Nigeria's northern Kano state during devastating meningitis outbreak. They claim that the pharmaceutical giant used children there for an unlicensed trial of what it hoped would be a new "blockbuster" drug - a broad spectrum antibiotic that could be taken in tablet form. Pfizer disagrees, insisting that it acted with approval from the Nigerian government and with the consent of…
revere | March 31, 2009Tufts University is the latest institution to step in the Conflict of Interest mess and come out with shoes that smell. The University had organized a conference on conflict of interest in medicine and research, with Iowa's Republican Senator Charles Grassley as the keynoter. Grassley has been an indefatigable crusader against instances of fraud and abuse against the federal government, and is a principal author and defender of the Federal False Claims Act, which allows whistleblowers to share in the recovery of fraudulently obtained monies (for an excellent account, see Henry Scammell's…
revere | March 24, 2009When the Wall Street Journal called attention to a claim that the Journal of the American Medical Association called a whistle-blower a "nobody" and a "nothing," a claim JAMA denied, I didn't know what to think. I was inclined to give JAMA the benefit of the doubt. Whatever dealings I've had (and they are few) with JAMA's editor in chief, Dr. Catherine DeAngelis, she's been pleasant and has a reputation for being a tough and intelligent editor. It sounded as if someone had gotten a little irritated and maybe said things in a way that wasn't quite appropriate, but these things happen. But…
revere | March 18, 2009The Conflict of Interest talk these days is all about doctors and medical school lecturers who are in bed with Big Pharma, but the bed is pretty crowded. Researchers are there, too. Not that this hasn't been a topic of conversation. And not that researchers aren't conscious of it and frantically trying to distance themselves from it. But it's nice and warm under the covers and its a friendship with benefits, as the younger generation likes to put it:
As accusations of undisclosed financial conflicts among university researchers swirl, drug makers and academics are entering a new stage of…
revere | March 5, 2009The Supreme Court ruled yesterday that if the FDA approves a drug, it doesn't mean you don't have to keep the labeling up to date if you should warn people. So that settles one question about FDA approval. The FDA put its stamp of approval on the drug Vioxx, too, but approved or not, Vioxx was not OK. Some unfortunate people traded their arthritis pain for a heart attack. Not a good trade. So the maker of Vioxx got sued. When the regulatory agencies don't do their job, that's about the only remedy left. More important, it is the only way to change the behavior of companies whose negligence…
revere | March 4, 2009When I was in medical school it was common to get gifts from drug companies. Since many of us had very little money, the gifts were welcome. One company gave me a Littman stethoscope, at the time, the most advanced stethoscope around. The same model costs about $100 now. I was glad to get it, although I can't tell you the name of the company. I forgot the names as quickly as I pocketed their gifts. We all got lots of free samples, too, and they were often things like tranquilizers sent through the mail and left in the magazine bin in my apartment house common mailbox area. Yes, these folks…
revere | February 28, 2009In a post the other day on some kind of flu vaccine mishap in Austria we called it a colossal screw-up. It turns out we may have understated the case. Maybe. Because while more details are leaking out, the company responsible for it, Baxter International, isn't saying exactly what happened on the grounds that it is confidential business information. You almost have to admire that kind of arrogance. Almost. Meanwhile Helen Branswell brings us more details:
The company that released contaminated flu virus material from a plant in Austria confirmed Friday that the experimental product contained…
revere | February 26, 2009As I write this the story is still hazy [see Addendum] but it sounds like the kind of colossal screw-up we had four years ago when the American College of Pathology sent a pandemic flu strain (H2N2) to thousands of clinical and hospital laboratories as part of routine competency testing (see here, here, here). That was inattention by CDC, whose Director was mesmerized by the bioterrorism phantom and couldn't see beyond them. This time it's a vaccine maker and the cock-up sounds pretty horrendous, although it is hard to figure out exactly what has happened given the incomplete descriptions and…
revere | February 24, 2009I'm not sure what to make of the report that scientists in Boston, California and the CDC in Atlanta have made monoclonal antibodies that protect mice against many different flu subtypes. Monoclonal antibodies are antibodies made by the descendants of a single immune cell (that is a single clone, hence monoclonal). Thus unlike natural antibodies, these are also monospecific, i.e., they are directed against one specific target. Our natural immune system "sees" a protein on the surface of the virus called hemagglutinin (HA), of which there are 16 broad subtypes and many, many variations within…
revere | January 13, 2009I know I shouldn't, but I just have to ask. What's with the bath tubs on the Cialis ads? (in case you live in a bubble, Cialis is for "erectile dysfunction," what we used to call impotence).
The original Cialis ads were faux tasteful things (at least compared to the really toe curling "Viva Viagra" ads) that always ended up with the couple holding hands in a natural setting. The impression you got was that when you take Cialis the time is usually right when you are outdoors. Inconvenient. Then at some point it morphed into the couple each in their own bath tubs, as in the pic from their…