Thursday, January 31, 2008
Friday, January 25, 2008
Negative Drug Trials Unreported
That headline covered a story under "Briefly" in Monday's Los Angeles Times Health section. I thought it was a joke to see if I was paying attention to what I was reading. Days after the debacle over Zetia and Vytorin study results not being reported by Merck and Schering-Plough, it seemed too coincidental that more drug studies were either kept secret, or worse yet, fudged to cover up the deleterious effects of the drugs:
Nearly one-third of antidepressant drug studies are never published in the medical literature, and nearly all happen to show that the drug being tested did not work, researchers reported Wednesday in the New England Journal of Medicine.
And in some of the studies that are published, unfavorable results have been recast to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University.
Even if not deliberate, they wrote in their report, "Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients."
Yesterday and today Merck and Schering-Plough took out two-page ads in the Los Angeles Times touting the wonders of Zetia and Vytorin and recommending following the advice of physicians with the assumption that the almighty result of lowering ldl cholesterol was a sufficient end in itself, regardless of the unhappy build-up of the killer plaque in arteries was also caused by these drugs.
High cholesterol levels in the blood have been blamed through the years on higher cases of arterial disease based largely on statistical correlation. The exact mechanism of plaque build-up in arteries is still not completely understood. Systemic "inflammation" may be a culprit, as well as high cholesterol levels, and the statin drugs may also have an effect on this inflammation which is helpful along with the lowering of serum cholesterol levels. And just which element of the cholesterol picture--low density lipoproteins (ldl) or high-density lipoproteins (hdl) or very low density lipoproteins (vldl)--is the "good" or "bad" cholesterol is all based on educated theory, some empirical and some statistical.
The Zetia/Vytorin ads state unequivocally that the ldl cholesterol is "bad" cholesterol. While this is probably true, it would be beneficial to the consumer in order to be well-informed, to know of the theoretical essence of such a statement.
I have received some antagonistic emails in the past in response to my commentary on pharmaceutical companies' deceitful practices. They were not published because of their inflammatory nature and uninformed opinions. However, when media reports continue to grow about the greed and illegal activities of drug manufacturers, it seems specious to argue about how wonderful these products really are. The one thing that is for sure, is that the bottom line for big pharma is the big buck, not public health.
Wednesday, January 16, 2008
Everyone's Wrong, Right?
That was the beginning of everyone doing everything wrong. The anchor on TV said to check out the channel’s web site for more information on the Obama-in-Van Nuys story. There was nothing remotely oriented toward any news about any presidential candidate in California on that web site, even though with the state primary only weeks away, the candidates are swarming into several CA localities in the next few days.
I called the news desk of that channel to ask about any further info about this event, and they politely declined to tell me anything except that it was by invitation only, and for nebulous security reasons they were not giving the location or address beyond the fact that it was going to be in Van Nuys, as mentioned on the TV show. I figured I would just listen for the familiar choppers overhead and follow them—it works for honing in on the instant whereabouts of Britney Spears, who lives very nearby, at least as the helicopter flies…when she’s picking out produce at our market at the end of the block, the “Apocalypse-Now” sounding downdraft is deafening.
I called Obama’s headquarters and the press relations people answered. They had no idea about any individual events since that was not their responsibility—they transferred me to the field office, at which there was only a voice mail recording available and I needed to leave a message, which I didn’t.
So much for seeing Obama—here is the blurb from LAObserved, a blog about happenings in the area:
Democratic contender Barack Obama has scheduled a "roundtable on economic opportunity" at a private home in Van Nuys tomorrow afternoon. He's also got a fundraiser Wednesday night at the Pacific Palisades home of Marianna and David Fisher, with co-hosts including Tom Unterman, Zeb Rice, Ted Field and others. It's the usual $2,300 requested per person and $25,000 for the co-hosts.
What is interesting about the “roundtable” is that on the news show this morning with the interview of the woman hosting in Van Nuys, the back yard looked real grungy with spotty areas of grass, and she said she had to move the trash barrels at the request of the organizers in order to make room for some tables and a tent. Maybe I didn’t miss much after all.
The Palisades to-do is a little beyond my budgetary reach, although in reality anything beyond a $5 contribution to a politician seems to me to be taking good money out of the hands of real needy charities, like curing cancer, or vaccine awareness etc…
Speaking of politicians, the arguably-democratically-elected leader of the free world was smooching with the dictator Saudi Sheiks in an effort to bolster good will with Bush’s favorite kingdom in the Middle-East. One of my favorite columnists, formerly Los Angeles Times op-ed writer fired last year I think because he was too smart for the corporate-owned Tribune’s graces, Robert Scheer, has written a punch-by-punch piece about Bush and his mayhem-making actions in foreign policy—it seems our president can’t give enough arms to them or money to Israel to make anyone happy:
What more can this president do to curry favor with the Saudis? He forgave them for nurturing the Wahhabism that spawned al-Qaida, and he never embarrasses them with the fact that bin Laden and 15 of the19 hijackers who attacked America on 9/11 were born and raised in the kingdom. Nor did Bush let the inconvenient fact that the Saudi government had backed the Taliban until 9/11 intrude on his cozy relations with the royal family. That warmth, displayed at ranching cookouts in both countries, has now been reinforced by $20
billion in U.S. arms sales to the Saudis and their Persian Gulf allies,
officially announced by Bush on Monday.At first, the Bush administration feared that some pro-Israel members of Congress might be able to derail the arms sale deal, but they solved that one by offering Israel $30 billion in new weapons. That’s a good deal for the Israelis and for U.S. arms manufacturers, although not for U.S. taxpayers stuck with the tab. No problem—neither the media nor Congress notices the cost to taxpayers of anything carrying the label of “national security.” Heck, Iraq’s defense minister was just in Washington with his shopping list for new weapons and didn’t cause much of a stir when he said the United States will have to defend Iraq for at least a decade more. So much for the impact of the $1 trillion already wasted on the Iraq debacle.
I never expected Bush to do anything “right” anyway.
Then came lunch, and a discussion with my wife’s cousin Rachel about grade school teaching, homework, and math. In this case no one in public school education administration does anything right. As belabored many times in this blog, the issue of homework being deleterious for the institution of the family, and unhelpful as a teaching prop; teaching math to students who may not want to be rocket scientists, and the curriculum in general stressing that all children be equally competent in all subjects—all are completely mishandled and improperly prioritized by state control of public education.
The subject arose in the first place because Rachel is visiting the Valley from Orange County (only relatives travel to visit relatives between these locales—no one does it on purpose otherwise—it’s too big a divide culturally) because she was “tapped” by a producer of a new game show about Bingo while she was playing black jack at an Indian Casino somewhere in the bowels of San Diego County several months ago. There is a potential to win a million bucks on this show, not to mention the fun of appearing on television. Who could resist? Anyone…anyone?
The caveat: it would be helpful to have a good acumen for trivia. For instance, Rachel was asked how many stomachs a cow has. I know a cow has four stomachs. Once I ever heard such an absurdly weird fact, I would be inclined never to forget it.
Rachel’s answer was, “How the f*** would I know how many stomachs a cow has and who cares? Why don’t they ask me where Britney Spears was born and raised?” about which fact Rachel knew nuanced details. I wondered silently why Britney Spears was becoming so much a part of my life.
My wife says I have a mind full of trivia. Actually, her description was that I know everything. That is clearly impossible; as much as I know, it is all important to me -- not trivial at all.
As for rocket scientists, the folks at the Jet Propulsion Laboratory got a vote of confidence from another of my favorite writers, newly moved to the Los Angeles Times op-ed page from its entertainment section, Tim Rutten, who is truly gifted in catching the phrase that adds just the right tone and meaning to his position. So he saved the day for me from everyone doing everything wrong—his article, Inquisition at JPL, was just right:
Tim is put out by how a clearly misguided directive to attempt to assure safer government employees by increasing back ground checks got out of hand in one case:
It doesn’t get any sillier. Until you read that the Food and Drug Administration says that food from cloned animals is safe. The FDA is the government agency that allows, among others, the ubiquitous seasoning MSG (monosodium glutamate), known to cause physical and nerve issues in millions of people, to continue to be approved. This is not even to mention the reams of cases of FDA conflict of interest in drug and vaccine approvals due to the immense force of big pharma lobby money. When people actually start to eat cloned animals, “silly” may become a major understatement of the situation.…the government demanded that the scientists, in order to get the badges, fill out questionnaires on their personal lives and waive the privacy of their financial, medical and psychiatric records. The government also wanted permission to gather information about them by interviewing third parties.
In other words, as the price of keeping their jobs, many of America's finest space scientists were being asked to give the feds virtually blanket permission to snoop and spy and collect even malicious gossip about them from God knows who.
Investigators wanted license to seek information as to whether "there is any reason to question [applicants'] honesty or trustworthiness." At one point, JPL's internal website posted an "issue characterization chart" -- since taken down -- that indicated the snoops would be looking for "patterns of irresponsible behavior as reflected in credit history ... sodomy ... incest ... abusive language ... unlawful assembly ... homosexuality." (We'll leave it to others to explain a standard that links incest with unlawful assembly.)
Finally, my favorite quote of the “doing things wrong” issue of today comes from the article about the cholesterol-lowering drug Vytorin. That drug, and one of its components sold separately as well, Zetia, accounted for 5 billion dollars in sales last year. The other component of Vytorin, symvastatin, sold alone as a generic, costs a few dollars for a month’s supply. Zetia and Vytorin can cost over $100 for a month’s worth of pills.
The latest news is that a study shows that while simvastatin lowers cholesterol in the blood and has a concomitant effect on reducing the killer plaque in arterial walls, Zetia, which lowers blood levels of cholesterol, may actually account for a slight increase in plaque build-up. Confusing, no?
Here’s the quote I like:
Meanwhile, the results "raise some very interesting questions," said Dr. P.K. Shah, a cardiologist at Cedars-Sinai Medical Center who was not involved in the study.
"Is the LDL hypothesis still alive and well after this?" he asked.
"Despite a 17-percentage-point reduction in LDL, [Vytorin] did not produce any changes better than the single drug alone. Many of us had not quite expected it to be that way."
I’ll bet! But even more telling than the pharmaceutical paradox of whether lowering LDL’s is good for you or not, is this blistering item:
Ya think? $5 bil is at stake!Results of the two-year study had originally been scheduled to be released in 2006, but the companies delayed them, saying that the analysis was extremely complex. At one point, the firms said they were going to change the study's design to simplify analysis, but critics objected and the researchers returned to their original plans.
Last month, the U.S. House of Representatives' Committee on Energy and Commerce launched an investigation into why the results
had not been released sooner.Critics had charged that the delays were the result of negative findings.
Tomorrow I’m going to wake up and to counterbalance today, everyone will do everything right—to start things off, I plan to skip my regular dose of Zetia tonight.