"When many cures are offered for a disease, it means the disease is not curable" -Anton Chekhov
''Once you tell people there's a cure for something, the more likely they are to pressure doctors to prescribe it.'' -Robert Ehrlich, drug advertising executive.
"Opinions are like sphincters, everyone has one." - Chris Rangel
And Now, Prozac: The latest drug to come under fire isProzac:
Eli Lilly & Co. documents linking the antidepressant Prozac to violence have been turned over to the U.S. Food and Drug Administration by the British Medical Journal, the publication says in its Jan. 1 issue.
The documents ``appear to suggest a link'' between Lilly's Prozac and suicide attempts and violence, the journal said. The papers ``went missing'' during a product liability lawsuit 10 years ago and were recently sent to the medical journal by an anonymous source, according to the journal's account.
A jury in 1994 found in favor of Lilly in the lawsuit, brought on behalf of victims of a 1989 workplace shooting. Joseph Wesbecker, who had a long history of depression, killed eight people and himself at a Louisville printing plant in 1989, a month after being put on Prozac.
One of the internal company documents, a report of 8 November 1988, entitled "Activation and Sedation in Fluoxetine Clinical Trials," found that in clinical trials "38% of fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine."
"Activation" refers to increased incidences of anxiety, agitation, and agressiveness. People experience depression in different ways - some mostly as anger, some as anxiety, some as suicidal despondency. It's difficult to sort out whether or not the increase in motivation to act on those feelings is due to the anti-depressant working - just improving things enough to improve motivation to but not wiping out the anger, anxiety, or suicidal thoughts - or how much of it is due to the chemistry of the drug:
Dr Joseph Glenmullen, a Harvard psychiatrist and author of The Antidepressant Solution, published by Free Press, said it should come as little surprise that fluoxetine might cause serious behavioural disturbances, as it is similar to cocaine in its effects on serotonin.
The SSRI's like Prozac still remain much safer than than the older anti-depressants, and it would be a terrible shame to lose them. But Eli-Lilly's behavior, as described in the BMJ seems reprehensible:
The plaintiffs in the Wesbecker product liability sought to show that Eli Lilly withheld negative study data from the FDA and that fluoxetine tipped Wesbecker over into a homicidal rage. Lilly won a 9 to 3 jury verdict in late 1994 and subsequently claimed that it was "proven in a court of law... that Prozac is safe and effective."
The trial judge, Justice John Potter, suspecting that a secret deal had been struck, pursued Lilly and the plaintiffs, eventually forcing Lilly in 1997 to admit that it had made a secret settlement with the plaintiffs during the trial. Infuriated by Lilly's actions, Judge Potter ordered the finding changed from a verdict in Lilly's favour to one of "dismissed as settled with prejudice," saying, "Lilly sought to buy not just the verdict but the court's judgment as well."
David Graham, currently associate director in the FDA's Office of Drug Safety, criticised the analysis of post-marketing surveillance data submitted by Lilly to the FDA. After discovering that Lilly failed to obtain systematic assessments of violence and had excluded 76 of 97 cases of reported suicidality, Dr Graham concluded in a memo dated 11 September 1990 that "because of apparent large-scale underreporting, [Lilly's] analysis cannot be considered as proving that fluoxetine and violent behavior are unrelated."
An FDA advisory panel was convened in 1991 to review the fluoxetine data. It concluded that fluoxetine was safe despite the concerns raised by Dr Graham and others, leading critics to point out that several of the panellists had financial ties to Eli Lilly.
...Dr Kapit, the original reviewer for fluoxetine, told the BMJ, "If we have good evidence that we were misled and data were withheld then I would change my mind [about the safety of fluoxetine]. I do agree now that these stimulatory side effects, especially in regards to suicidal ideation and homicidal ideation, are worse than I thought at the time that I reviewed the drug."
A lot of this current mess could have been avoided if the companies making these drugs had been more upfront with their findings a decade and more ago. The drugs probably would have been approved, but with warnings about the potential side effects. It's the lack of transparency that chafes so.
Tsunami News: The primitive peoples living on small, remote islands in the Indian Ocean are, apparently, mostly safe, and not too wild about getting aid, evidently:
Our helicopter pilot who flew over the island told me that he has seen several groups of Sentinelese on the beach and that when he dropped food packets they threw stones at the helicopter.
Art and Science: The science behind the silhouettes:
The phenomenal success of the work of the Swiss pastor Johann Casper Lavater (1741-1801) also contributed to the popularity of the art. Lavater linked silhouettes to the 'science' of physiognomy, which aimed to discern a person's character from their facial features. His Essays on Physiognomy, Designed to Promote the Knowledge and Love of Mankind were first published in Germany in 1772 and translated into English and French in the 1780s. They promoted the simple contours of a silhouette as the best means of 'reading' a face: "What can be less the image of a living man than a shade? Yet how full of speech! Little gold, but the purest." posted by Sydney on
12/29/2004 09:34:00 PM
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"In the name of children everywhere, our family wants Children's Motrin taken off the market until it carries a warning label about the risk of Stevens-Johnson Syndrome and describes its symptoms," the girl's mother said in a statement.
Steven's Johnson syndrome is a severe immune reaction that can be triggered by a variety of outside factors - from drugs to viral or bacterial infections. There is no way to tell whether the child's reaction was caused by the Motrin or by the virus that presumably caused her fever. It is one of those illnesses that is unpredictable and unavoidable. And this suit is one that never should have been filed. The attorney involved isn't one to miss any pertinent opportunity, however:
"This is the equivalent of a medical tsunami -- there was no warning put out whatsoever on this apparently benign, over-the-counter medicine," Sabrina Brierton Johnson's attorney Browne Green said.
I'm not sure how an illness that strikes 2 to 3 people per million world wide over the course of a year qualifies as a natural disaster on the scale of tsunami that kills over 100,000 people within the blink of an eye, except that they're both due to uncontrollable forces of nature. The other difference is that you can, apparently, predict a tsunami. There's no predicting Steven's-Johnson syndrome - at least not with our current knowledge and technology. posted by Sydney on
12/29/2004 09:03:00 PM
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Tsunami Relief: Thailand needs forensic volunteers to help collect samples and identify bodies before cremation. With estimates now standing at over 100,000 dead they could certainly use the help. The Tsunami Help blog has much more on other relief efforts and way to help. And don't forget the Amazon American Red Cross Tsunami Relief Fund, now standing at over $3 million.
UPDATE: Here's a site with tsunami videos. It's amazing how unexpected the power, speed, and breadth of the waves were. I've always thought of tsunamis as really tall waves, but they're actually broad, fast waves. In some of the videos, it's apparent that the people aren't aware of what's coming at them until the waves are just a few feet away from them. posted by Sydney on
12/29/2004 08:37:00 PM
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Pepper Pots: Hope may be on the way for arthritis sufferers in the form of hot peppers. Capsaicin, the active ingredient in hot peppers, is already available as a cream. A few years ago it was all the rage, but its clinical performance has been disappointing.
This, however, sounds daring:
In fact there's a hot pepper nasal spray actually being sold throughout the nation by the name of Sinus Buster. It's an all natural nasal spray (the world's 1st hot pepper nasal spray), and it's been solidly embraced by the medical community as a true breakthrough for relieving inflammation and pain associated with chronic headaches, sinus, and allergy conditions.
UPDATE: Some advice from a reader on how to relieve an overdose of pepper cream:
You might want to post a short note saying that the remedy for getting Capsasian or any form of capsicum in the wrong place is to rub the area gently with sour cream. You may think that's pretty far out, but after using it for 40+ years, my family swears by it. It's not suitable for use on the eyes, but anywhere else, it works. posted by Sydney on
12/29/2004 08:14:00 PM
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At New York Medical College, there are clubs for Jewish students, lovers of ballroom dance and those who are passionate about neuroscience, orthopedics or pediatrics.
Until recently, gay students also had their own organization, one that the Catholic-affiliated college allowed to exist as long as there was nothing that hinted of homosexuality in the title, such as the words "pride" or "rainbow." But when the Student Support Club changed its name to Lesbian Gay Bisexual and Transgender People in Medicine, it found it was not welcome on campus and was told to disband.
The news report makes much of the college's affiliation with Catholic hospitals and the Archdiocese of New York, which helped the school get out of some financial difficulties in the 1970's. I never realized it was a Catholic school, but it is a private school, and its CEO is a monsignor. He also holds a masters degree in public health, which would explain the totalitarian approach. (Other Catholic schools are more tolerant.) posted by Sydney on
12/29/2004 08:04:00 PM
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Crusading Cardiologist: Dr. Eric Topol of the Cleveland Clinic has come out against direct to consumer drug advertising - at least when it comes to arthritis drugs. He appears to make exceptions for cholesterol lowering drugs:
Rather than a sufficient waiting period after approval to firmly establish safety in the large, representative 'real world' population, the unbridled promotion exacerbated the public health problem. This is so poignantly clear for an indication such as arthritis, which is one of the most common conditions requiring medication. Furthermore, one has to question the wisdom of allowing direct-to-consumer advertising for lifestyle medications that have no capability of preserving life or preventing major events such as MI or stroke. Here the paradox of actually promoting these events is all the more difficult to accept. (emphasis mine)
It's true that direct to consumer advertising of prescription drugs increases the demand for drugs. The biggest problem with advertising, though, is that the target audience doesn't actually pay for the product, at least not directly. But if Dr. Topol could lay aside his cardiovascular bias for a moment, he would recognize that cardiovascular drug makers are just as guilty of overmarketing their product as any other drug maker. Cholesterol lowering drugs are advertised just as aggressively as arthritis drugs, with commercials that make it seem as if taking them will keep people safe from heart attacks and strokes. In fact, taking them will only reduce the risk from about 15% to 12% for each individual, and there have been studies that suggest they may increase the risk of cancer in the elderly. ( Dr. John Abramson's Overdosed America is an excellent source for the details of the various statin studies and what they do and don't say about the benefits and risks of the drugs.)
It's also wrong to assume that for every individual patient, preventing future heart disease is more desirable than alleviating the suffering of pain. Ask an 80 year old woman which she would opt for - a cholesterol medicine that lowers her risk of heart disease by three percent over ten years or an arthritis medicine that makes it possible for her to visit her grandchildren but increases that risk by 3%. More than likely, she'll choose the latter. posted by Sydney on
12/29/2004 08:45:00 AM
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Israeli doctors were among the first foreign medical personnel to reach Sri Lanka in the aftermath of Sunday's devastating tsunami that left thousands dead in that country alone.
"We got a phone call that we were needed, and three hours later we were at the airport," said Prof. Avi Rivkind, head of both the Department of Surgery and Trauma Unit at Hadassah University Hospital, Ein Karem in Jerusalem.
Rivkind flew to the battered country on Sunday night, along with three other Hadassah physicians, who specialize in rescue operations, trauma and pediatrics.
...'We're here to identify problems and offer a hand any way we can,' he said. 'We will try to use our broad experience in dealing with terror attacks and rescuing masses to help in this disaster as well,' Rivkind told Ha'aretz. posted by Sydney on
12/29/2004 08:29:00 AM
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Crumudgeonly Doctors: Dr. House is alive and well in the UK, where doctors are going to be "revalidated" every so often to make sure no one else turns into a homicidal maniac like the infamous Dr. Shipman. One doctor's response:
According to the Royal College of GPs, an “excellent” GP prescribes only treatments that will be effective, makes management decisions based on evidence and is honest when completing certificates and reports. At Copperfield’s Surgery of Real Life, patients demand treatments with little hope of success, don’t understand the concept of evidence-based medicine and expect me to lie through my teeth on insurance claims.
So I’m going to start by grassing myself up to the GMC. Yes, I prescribe placebo antibiotics if there’s no other way to get the punter out of the room without charging up the cattle prod, and I have also ignored the occasional ski-goggle tan when signing sick notes in February. Revalidate that. posted by Sydney on
12/27/2004 07:56:00 AM
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Into the Abyss: The holidays are a terrible time for the depressed. It seems very Christmas Eve, someone comes into my office threatening to kill themselves, and the number of trips I have to make to the psychiatric ward for medical consults seems to go up around this time of year, too.
Cancer and Aging: New research may have found the molecular basis of cancer in aging cells:
In order to solve the cancer mystery, You's team investigated the human gene Bcl-2, which causes the arrest of growth or aging of cells, and found the Bcl-2-induced cell growth slowdown does not protect these cells from shifting to explosive cell growth.
Instead, Bcl-2 barred the DNA repair mechanism, depriving the human body of a significant tool in countering mutations, dramatically heightening the likelihood of tumors appearing.
"Up until now, scientists have suspected cells accumulate mutations when they are young and become tumors when they are old. But we have learned aged cells suffer abrupt mutations due to a lack of DNA repair," You said. posted by Sydney on
12/27/2004 06:37:00 AM
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The Harm in Over-reaction: USA Today, of all places, has an excelletn editorial on drug safety.
UPDATE: And The Wall Street Journalweighs in, too:
One of the most frustrating things about the latest news on painkillers is that almost none of the people reporting it understand the concept of relative risk--i.e., that a doubling of adverse events like heart attacks still doesn't mean that event is very likely. A doubled risk might well be a chance worth taking, especially if the baseline risk is low to begin with and the drug's benefits are significant for the patient in question. All of us implicitly accept this proposition with chemotherapy, for example, which poisons the entire body to kill a few cancer cells. posted by Sydney on
12/27/2004 06:12:00 AM
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Sunday, December 26, 2004
False Truths: It isn't available on-line, but this week's New Republic has an excellent book review by Anne Applebaum, author of Gulag : A History. The review is of Richard Overy's book The Dictators: Hitler's Germany, Stalin's Russia, and is titled "How Evil Works." It is an attempt to figure out just why it was that such totalitarian regimes as Stalin's Russia and Hitler's Germany enjoyed such popularity among the people they ruled. The answer, according to Applebaum, is that they both presented themselves as being founded upon the scientific truths:
The science itself was very different in Soviet and Nazi society, in other words, but its function was essentially the same. The supposed neutrality and incontrovertibility of scientific doctrine gave both regimes a good part of their intellectual legitimacy. Science, or rather pseudoscience, gave people a moral justification for behavior that had formerly been unthinkable. German concentration camp guards, convinced that their Jewish prisoners were biologically inferiour humans, had few qualms about murdering them. Soviet concentration-camp guards, convinced that their political prisoners were flawed humans who had to be re-educated through hard labor, saw nothing wrong with mistreating them, even if they died in the process.
State of Preparedness: A report from earlier this month indicates that most states still aren't up to par when it comes to bioterrorism preparedness:
The report examined 10 key indicators to gauge state preparedness and determine America’s overall readiness to respond to bioterrorist attacks and other health emergencies. This is the second year in a row that TFAH conducted a review of bioterrorism and public health preparedness, while the federal government’s efforts to release performance measures have stalled.
Over two-thirds of states and D.C. achieved a score of six or less. Florida and North Carolina scored the highest, achieving nine out of the possible 10 indicators, and Alaska and Massachusetts scored the lowest, at three out of 10. Although direct comparisons are difficult because the indicators were modified to reflect the changed expectations of additional time and funding, in this year’s report, 34 states and D.C. obtained higher scores, nine scores remained the same, and seven scores declined.
Maybe it's time Congress investigates where all that money they gave each state went. Better to do it now than to wait until after a bioterror attack.
If you click on the link, you can find out just how each state measured up.
Libyan Madness Update: The Bulgarian nurses and Palestinian doctor sentenced to death in Libya for allegedly infection a multitude of children with HIV may get a reprieve. posted by Sydney on
12/26/2004 08:30:00 AM
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