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    Friday, December 24, 2004

    Merry Christmas


    May you, too, bask in the light of Love.

     

    posted by sydney on 12/24/2004 01:05:00 AM 1 comments

    Thursday, December 23, 2004

    Resiliencey of Evil: Take away the guns, and they'll just find something else to use - like this drive-by knifing.
     

    posted by sydney on 12/23/2004 03:54:00 PM 0 comments

    Fat and Fit;Lean and Lazy: It's all the same, according to this week's latest research:

    The study of 116,500 women was published in the New England Journal of Medicine today.

    Women who were physically active but obese had almost twice the risk of death of women were both active and lean. Women who were sedentary but slender were 55 % more likely to die early. Women who were both sedentary and obese were almost 2 times more likely to die.

    “Being physically active did not cancel out the increased mortality of overweight. Being lean did not counterbalance the risk effect of being sedentary,” Hu said.

    Dr Timothy Church of the Cooper Institute, which is devoted to research on exercise and health, praised the findings. “If you’re lean but you’re sedentary, don’t fool yourself. You’re still at risk. You need to get physically active,” he said.


    Unfortunately, as is so often the case with obesity studies, this one only presents its findings in terms of relative risk. Still, the greatest difference appears to be for the morbidly obese (BMI greater than 40). There were rather modest differences for those in the more common BMI categories of 25 to 30, which is still considered overweight.
     
    posted by sydney on 12/23/2004 03:38:00 PM 0 comments

    Attack of the Killer Tomatoes: Mother of four succumbs to tomato sauce. Food allergies are nothing to sneeze at.
     
    posted by sydney on 12/23/2004 03:00:00 PM 0 comments

    Misleading Ads: There is evidently some disagreement between the FDA and AstraZeneca about the safety of their new cholesterol-lowering drug, Crestor. The FDA has asked the company to withdraw advertisements which claim the FDA has :full confidence" in the drug's safety:

    AstraZeneca LP, the US arm of the London-based manufacturer, began the national advertising campaign after Food and Drug Administration whistle-blower David Graham named Crestor among five unsafe drugs the agency failed to yank from the market.

    'You can be assured that at AstraZeneca, patient safety is our number one priority,' began ads that ran Nov. 23 to Nov. 29 in such publications as the Los Angeles Times, The New York Times, USA Today, The Wall Street Journal, and The Washington Post.

    The print advertising added, in bold type, that the 'FDA has confidence in the safety and efficacy of Crestor.' According to the ad, FDA scientists responsible for drug approval 'publicly confirmed that Crestor is safe and effective.'

    In a letter posted on the FDA's website, the agency called that suggestion misleading. The letter quoted from an interview with Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research,, saying the FDA 'has been very concerned about Crestor since the day it was approved.'


    Well, I'll keep that in mind.

    UPDATE: Here's the FDA's Crestor letter. They have some considerable concerns about the 40mg dose of the drug:

    During the clinical trials, Crestor was shown to cause myopathy at the 40 mg dose. Prior to approval, the Agency recommended (and AstraZeneca agreed to) a risk management plan in which "[three] ongoing clinical studies with patients receiving long term treatment with 40 mg daily of Crestor...should have regular renal monitoring with urinalysis and serum creatinine measurements in order to better describe the clinical course of the renal findings."

    As a consequence of the risks identified with the 40 mg dose, the August 12, 2003 approval letter for Crestor refers to a premarketing submission of July 18, 2003 in which AstraZeneca describes voluntary special distribution measures for the 40 mg dose of Crestor "to ensure that the 40-mg dose is available only to patients who truly need this dose." The special distribution measures were undertaken by AstraZeneca because the Medical Review concluded that the 40 mg dose was only appropriate for "patients with severe hypercholesterolemia who have not responded adequately to all other available forms of therapy.

    The "patient safety" print ad presents false or misleading safety claims that minimize the risks associated with Crestor. The ad is headlined "You can be assured that at AstraZeneca, patient safety is our number one priority" and seeks to assure readers that Crestor is "more effective and just as safe" as the leading medications in its class." These false or misleading claims include:

    · "A medication can be more effective and just as safe."

    This claim is misleading because it minimizes the risks associated with the 40 mg dose of Crestor. As discussed previously, these risks led to AstraZeneca agreeing to special distribution measures for Crestor 40 mg and to conduct three long-term post-marketing clinical trials to further assess the safety of the 40 mg dose. The PI reflects this concern, stating "The 40-mg dose of CRESTOR should be reserved for those patients who have not achieved goal LDL-C at 20 mg...." FDA is not aware of substantial evidence or substantial clinical experience demonstrating that all doses of Crestor are "just as safe" as other statins.

    Similarly, we are concerned about the section of your ad entitled, "The FDA has confidence in the safety and efficacy of CRESTOR" in that it misleadingly suggests that the Agency does not believe that Crestor poses safety concerns. Specifically, your ad states:

    · "The scientists at the FDA who are responsible for the approval and ongoing review of CRESTOR have, as recently as last Friday, publicly confirmed that CRESTOR is safe and effective; and that the concerns that have been raised have no medical or scientific basis."

    The citation for this claim is "www.fda.gov accessed on 11/19/04." There is, however, no statement on the website by FDA concluding that "the concerns [about Crestor] that have been raised have no medical or scientific basis." In fact, recent public statements made by the Agency contradict that conclusion. For example, in an article entitled "Campaign Waged Against Crestor" appearing the previous week (on November 18, 2004) in the Washington Post, which discusses the safety concerns raised by the consumer advocacy group Public Citizen about Crestor, Dr. Steven Galson, Acting Director of the FDA's Center for Drug Evaluation and Research is quoted as saying:

    · "[the Agency] has been very concerned about Crestor since the day it was approved, and we've been watching it very carefully." Dr. Galson further stated that the Agency is "concerned about the same issues with Crestor as Public Citizen."


    Not long ago, AstraZeneca's CEO was blaming drug safety problems on the indiscriminate prescribing by primary care doctors. Looks like he's yet to take a good long look in the mirror.
     
    posted by sydney on 12/23/2004 09:35:00 AM 0 comments

    Double Dipping: Handsome consulting fees for NIH researchers:

    Today, Los Angeles Times reporter David Willman writes that at least 530 NIH scientists have been paid large consulting fees, or been given stock or stock options by biomedical companies during the past five years.

    Willman, who revealed the extent of industry ties to NIH scientists a year ago, continues his investigation of the outside business arrangements. Among those he cites::


    Dr. P. Trey Sunderland III, a senior psychiatric researcher, took $508,050 in fees and related income from Pfizer Inc. at the same time that he collaborated with Pfizer -- in his government capacity -- in studying patients with Alzheimer's disease. Without declaring his affiliation with the company, Sunderland endorsed the use of an Alzheimer's drug marketed by Pfizer during a nationally televised presentation at the NIH in 2003.


    Dr. Harvey G. Klein, the NIH's top blood transfusion expert, accepted $240,200 in fees and 76,000 stock options over the last five years from companies developing blood-related products. During the same period, he wrote or spoke out about the usefulness of such products without publicly declaring his company ties.


    Such collaborations are encouraged by the NIH, writes Willman, although the extent of the private arrangements apparently came as a surprise to NIH director Dr. Elias A. Zerhouni. In response to Congressional critics earlier this year, Zerhouni said that he supported tighter restrictions on outside employment. Yet the U.S. Office of Government Ethics "found that 40 percent of the 155 outside payments to NIH employees it sampled randomly had not been approved or accounted for within the agency," Willman reports.

     
    posted by sydney on 12/23/2004 09:03:00 AM 0 comments

    Go Ahead and Get the X-Box: Video games make better surgeons:

    Surgeons who play video games three hours a week have 37 percent fewer errors and accomplish tasks 27 percent faster, he says, basing his observation on results of tests using the video game Super Monkey Ball.
     
    posted by sydney on 12/23/2004 08:12:00 AM 0 comments

    New Drug Warning: The FDA says that Strattera, a drug for attention deficit disorder, may cause liver damage:

    The Food and Drug Administration (FDA) is advising health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered.

    ...The labeling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients. The labeling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events.

     
    posted by sydney on 12/23/2004 08:02:00 AM 2 comments

    Wednesday, December 22, 2004

    Just Wondering: If it's against the law to refer patients to a lab or x-ray facility you own, is it also against the law to write an order for a lab or x-ray for a patient at the request of said lab/xray facility's owner, who is also the patient's consulting physician? It seems it would be at least a violation of the spirit of the law, if not the letter.

    UPDATE: From a reader:

    Isn't that considered "scoping" and an integrally collusive networking objective of corrupt practice "groups" or individuals?

    UPDATE II: Another reader says it violates the letter as well as the spirit of the law and sends the relevant citation:

    Federal law prohibits certain referral arrangements, where the referral would violate Stark had it been made directly. 42 USC 1395nn(g)(4) provides the following:



    (4) Civil money penalty and exclusion for circumvention schemes

    Any physician or other entity that enters into an arrangement or scheme (such as a cross-referral arrangement) which the physician or entity knows or should know has a principal purpose of assuring referrals by the physician to a particular entity which, if the physician directly made referrals to such entity, would be in violation of this section, shall be subject to a civil money penalty of not more than $100,000 for each such arrangement or scheme. The provisions of section 1320a-7a of this title (other than the first sentence of subsection (a) and other than subsection (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section 1320a-7a (a) of this title.

     

    posted by sydney on 12/22/2004 01:22:00 PM 0 comments

    Ukrainian Medical Mystery Update: The type of dioxin used to poison Viktor Yushchenko was evidently of a very pure quality, so pure it was likely made in a lab. It's also been confirmed that it was the highly toxic TCDD type. Gail Bell explains why dioxin:

    What if the intention was not to kill Yushchenko but to injure him in ways that mimic a fall from grace, like superimposing the ruined face of an alcoholic onto a once handsome man? This is a glimpse, I suspect, into the secret world of chemical warfare, the successor to the old poisoners' guild, and even, perhaps, a peep behind the shreds of the iron curtain. Steady doses of dioxin cause cancer and premature aging.

    Dioxin, then, seems tailor-made to topple an Adonis from his plinth, which for someone in the public eye is a kind of death.
     
    posted by sydney on 12/22/2004 01:15:00 PM 0 comments

    Greed: A British doctor has been sentenced to nine months in jail for falsifying test results. Why on earth would a doctor do that? To protect his income, which was a very nice one, indeed:

    Thousands of families, concerned at reports that autism could be linked to the controversial all-in-one measles, mumps and rubella (MMR) jab, paid £70 to have separate inoculations for their children at Pugh’s Elstree Aerodrome clinic, the court was told. The practice treated around 250 children a week and had a weekly turnover of around £17,500 at the height of the autism scare in 2002.

    But parents flooded the clinic with calls 18 months ago after a newspaper report that inoculations given at the clinic might not be effective, because of the way they were being prepared and stored.

    Pugh, who also ran a private clinic in Sheffield, offered free blood tests to worried parents in an attempt to prove whether or not their child was protected by the jab. But he then changed test results which showed that children had not been properly inoculated, to deceive parents and protect his business.

    Pugh inserted the results of a blood test on his 26-year-old daughter Josephine, who was inoculated against the three diseases, into negative blood tests on two of his child patients.


     
    posted by sydney on 12/22/2004 01:08:00 PM 0 comments

    Syndrome Watch: Post-Melodramatic Stress Disorder
     
    posted by sydney on 12/22/2004 01:00:00 PM 0 comments

    Privacy Privilege: A woman is suing Wal-Mart for her her daughter's suicide:

    Near the end of her short life, Shayla Stewart, a diagnosed manic-depressive and schizophrenic, assaulted police officers and was arrested for attacking a fellow customer at a Denton Wal-Mart where she had a prescription for anti-psychotic medication.

    Given all those signs, her parents say, another Wal-Mart just seven miles away should have never sold her the shotgun she used to kill herself at age 24 in 2003.

    Her mother, Lavern Bracy, is suing the world's biggest store chain for $25 million, saying clerks should have known about her daughter's illness or done more to find out.


    Pharmacy prescription records are subject to federal privacy rules. No one can gain access to those without written permission from the patient. (With some exceptions, such as law enforcement agents investigating a crime.) Buying a gun isn't a crime,though. And the Wal-Mart did ask her about mental illness, but she lied. What's more, although federal law prohibits selling guns to mentally ill people, according to the story, 38 states prohibit release of information about mental illness. It's hard to see how it's Wal-Mart's fault that she killed herself. Without a gun, she surely would have found another method.
     
    posted by sydney on 12/22/2004 12:52:00 PM 0 comments

    Death Takes No Holiday: Recent research says that people die every day, even at Christmas. Of course people die on Christmas. The researchers set out to see if it was true that people could postpone death for an important event. Anecdotes abound about this phenomenon. I myself have one. I man went to high school with a man who developed metastatic malignant melanoma in his early thirties. He was critically ill and drifting in and out of consciousness during the final days of his wife's pregnancy. He died the day his daughter was born, just after he held her for the first time. Everyone says he held on until her birth. And maybe he did. I'm sure the birth of his daughter was a considerably more important event for him than Christmas. As a critic of the research says:

    'This paper was painful for me to read,' Ferrell said. 'They asked the wrong questions and got the wrong answers. People don't wait around for Thanksgiving; Christmas really isn't a big deal.

    'I've been in this field for 27 years and I can tell you that people postpone death ... for something important: the birth of a grandchild, a bar mitzvah, a graduation, a baptism. I can give you thousands and thousands of examples of people who were waiting for redemption, forgiveness, mending relationships.'


    It's true, the study only looked at deaths around the holidays. It would be very difficult to do a study looking at death rates around individually important events. But the author does have a word of advice:

    'But what people have to understand is that there are important messages here: One is, if you have a loved one who is dying ... and if a major event is approaching, celebrate it now. Don't wait.'

    Did I mention that my classmate's wife convinced her obstetrician to do an elective Cesarean section before she started labor, so she could be sure her husband saw their daughter?

    NOTE: Typed too fast this AM minutes before having to leave for the office. Have since corrected post so it's half-way intelligible.
     
    posted by sydney on 12/22/2004 08:49:00 AM 0 comments

    Survival of the Weak: The world's smallest baby:

    Rumaisa Rahman was lighter than a can of soda and about the size of a cell phone when she was delivered prematurely Sept. 19, at 25 weeks and six days of gestation by Caesarian section. Her paternal twin sister, Hiba, weighed 1 pound, 4 ounces and was born at 4:21 p.m., two minutes earlier.

    It's absolutely amazing what neonatologists can do. She and her twin had a remarkably uneventful course:

    Both babies were fortunate to avoid many complications that are common in premature births, said senior pediatric resident Julie Herst, who was present during delivery and has attended to the girls since then.

    A recent ultrasound showed no bleeding of the brain in Rumaisa, and neither twin has suffered any major infections. Both, however, required laser surgery to prevent blood vessels behind their retinas from bursting, which Herst said is a common condition in premature babies.

    The parents, who were told their daughters faced a 50/50 chance of survival, were awe-struck Tuesday at the media attention and expressed hope their children would lead normal lives.

     
    posted by sydney on 12/22/2004 08:46:00 AM 0 comments

    Tuesday, December 21, 2004

    Reader Mail: On Naprosyn and other dangerous drugs:

    The problem is that we must stop and think for a minute, something which the FDA has not done. We know quite a bit about NSAIDs and the risk of vascular events. The only COX inhibitor proven to reduce the risk of myocardial infarction is aspirin. That was confirmed by The Antithrombotic Trialist Collaboration (BMJ 2002) which reviewed many studies including 5 randomized trials of more than 60,000 men and women. Aspirin reduced the risk of first myocardial infarction by 32%. The VIGOR study included 8000 patients with rheumatoid arthritis randomized between rather high doses of rofecoxib and naproxen. Rates of MI were 4 times as high in the Vioxx group as with naproxen. Then we were told that naproxen had some vascular protective effects and that a better comparison would be rofecoxib vs. Ibuprofen (nicer for the drug company). Naproxen has more effects on COX-1 and platelets than Ibuprofen does, and several studies suggest weak anti-thrombotic naproxen effects, but naproxen has never been proven to reduce the risk of vascular events compared to placebo. The recent TARGET study compared the incidence of various problems, including cardiovascular events in 9156 patients age 50 years or older randomized to lumiracoxib (another Cox-2 inhibitor) 400 mg QD, naproxen 500 mg twice daily (4754), or ibuprofen 800 mg three times daily (4415) in two identical sub studies. The primary cardiovascular endpoint was non-fatal and silent myocardial infarction, stroke, or cardiovascular death. Here are the results:

    Confirmed/probable cardiac or Cerebrovascular events:

    Lumiracoxib (85/9117 or 0.93%) both NSAIDs 75/9127 (0.82%)

    All myocardial infarction:

    Lumiracoxib 23 (0.25%) both NSAIDs 17 (0.19%)

    L’coxib vs. Ibuprofen 5 (L) & 7 (I)

    L’coxib vs. Naproxen 18 L (0.38) & 10 N (0.21%)

    None of these differences are statistically significant. This big prospective study shows that naproxen is at least as good as Ibuprofen in terms of cardiovascular events. Therefore if the FDA is to suggest that naproxen be used for no more than 10 days, they must do the same for Ibuprofen.

    This is lunacy. The FDA and the DOD are under fire, bobbing and weaving with hasty daily press releases. The heads of both agencies should be put on notice: think before you open your mouth. It was reasonable to stop the Alzheimer study. It was unreasonable to suggest that Naproxen increases the risk of cardiovascular disease for the general population.

    I think that it’s clear that all selective Cox-2 inhibitors modestly increase the risk of MI and stroke; they should not be taken off the market; they should not be used in persons above age 40, which still leaves a significant group of patients with migraine, connective tissue diseases, etc below 40. Patients above age 40 without any cardiovascular risk factors can take Ibuprofen or Naproxen, but shouldn’t push them to high doses. They should use physical therapy and acupuncture to help control joint pain. Patients with definite cardiovascular risk factors should take aspirin and generic omeprazole, which costs less than the brand name COX-2 inhibitors, and has no higher incidence of GI bleeding. We must get away from this idea of miracle drugs and pay much more attention to diet and exercise. Physicians must be more skeptical about drug company promotions and gifts and must individualize treatment to particular patients. There isn’t going to be a magic bullet for all humans in pain – the tremendous effects of age and genetic heterogeneity guarantee this.

    ....I own no drug company stocks, I can supply a list of 18 references to any interested parties.


    And Precision Blogger asks what doses were used in the studies. That's a good question. The Celebrex study used dosages that were twice the normal dose used for arthritis. I don't know what doses were used in the narpoxen study.
     

    posted by sydney on 12/21/2004 08:49:00 PM 0 comments

    Fast, Cheap, and Out of Control: The Task Force on Drug Importation has released its report. It concludes that imported drugs can be safe or cheap but not both:

    Importing cheaper prescription drugs from Canada could be done safely in a large, highly regulated commercial enterprise, says U.S. Surgeon General Richard Carmona.

    But it would cost hundreds of millions of dollars to police and the savings for consumers wouldn't be that high, he said. Carmona's long-awaited task force report on the issue, released Tuesday, said it would be 'extraordinarily difficult and costly' to ensure the safety of personal imports and most Americans would be better off simply using more generic drugs that can cost half what they do in Canada.


    Kind of like that old saying about service: Good, fast, cheap. Choose two.
     
    posted by sydney on 12/21/2004 08:45:00 PM 0 comments

    In God We Trust: A national survey of physicians finds us to be people of faith:

    A national survey of 1,100 physicians, conducted by HCD Research and the Louis Finkelstein Institute for Religious and Social Studies of The Jewish Theological Seminary in New York City over the past weekend, found that 74% of doctors believe that miracles have occurred in the past and 73% believe that can occur today.

    We have to believe in miracles. With the way the FDA and the media are reacting to our pharmacopeia, we'll soon have no other means to treat.
     
    posted by sydney on 12/21/2004 08:21:00 PM 0 comments

    Grand Rounds: Is up.
     
    posted by sydney on 12/21/2004 01:48:00 PM 0 comments

    Cranky Doctor Show: Last month, I panned the new medical drama, Dr. House. My oldest son has become a fan of it, despite my best efforts to convince him it's no good. (He likes dark characters. I knew I should never have let him read those Lemony Snicket books when he was little.) After reading about this episode, though, I'm thinking I should give it another chance. It sounds like the characters may be developing.

    UPDATE: Dr. Alice likes it, too. I definitely have to give the show another chance.
     
    posted by sydney on 12/21/2004 01:03:00 PM 0 comments

    Got Arthritis? Suck it Up: Now the FDA is warning that one of those old stand-by arthritis drugs that are supposedly safer than the newer ones like Celebrex and Vioxx aren't safe either:

    The Food and Drug Administration issued a warning to users of the over-the-counter pain reliever naproxen Monday after federal researchers found an increased number of heart attacks and strokes among users.

    The warning springs from an NIH study which was being done to see if Celebrex or Naprosyn would decrease the incidence of Alzheimer's disease in those over 70 years of age. The researchers reported a 50% increase in heart attacks and strokes in those taking Naprosyn over those taking Celebrex. Confused? We all are. As usual, details are sparse, but this CNN report offers some information:

    The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients, aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or placebo.

    The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking.

    ...
    John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that about 70 patients of the 2,500 suffered stroke or heart attack, including 23 deaths, and that there were about 50 percent more such events in the naproxen arm of the study than in the placebo division.


    That's 70 strokes or heart attacks in the entire study, which means the numbers of heart attacks and strokes in the two groups were exceedingly small. That translates into 42 strokes or heart attacks in the 1250 people who took Naprosyn and 28 strokes or heart attacks in the 1250 people who took Celebrex, or 3% vs. 2%. Please note that 97% of people taking Naprosyn had no strokes or heart attacks, and 98% of people taking Celebrex had none.

    And if drugs like Vioxx and Celebrex cause heart disease and strokes because their biochemistry increases the likelihood of clotting, as many critics have suggested, then why would Naprosyn, which has a biochemistry detrimental to clotting, be riskier than Celebrex? Because the findings have all been based on small and insignificant numbers. The difference between 3% of people having a complication and 2% is clinically meaningless.

    It's too bad that we've decided to exaggerate the risks of these drugs. If we keep it up, we won't be able to prescribe anything.
     
    posted by sydney on 12/21/2004 08:32:00 AM 0 comments

    Holiday Favorites: It's a wonderful bunny life.
     
    posted by sydney on 12/21/2004 08:01:00 AM 0 comments

    State of Adult Stem Cells: Michael Fumento has a link-rich review of the state of the art of adult stem cell research. It's showing a lot more promise than you might think if you only read about it in the papers.
     
    posted by sydney on 12/21/2004 07:59:00 AM 0 comments

    Monday, December 20, 2004

    Prohibition: The tiny monarchy of Bhutan has banned smoking everywhere except in private homes:

    People who cannot kick the habit can import tobacco for personal use, but at a 100 percent tax. They can only smoke indoors in the privacy of their homes.

    Shops and businesses defying the ban face fines starting at $225, a steep amount by Bhutan's standards, and repeat violators would risk losing commercial licenses.

    Bhutanese officials said only an estimated one percent of the country's 700,000 people smoked or used tobacco. The loss to tobacco businesses was not immediately known.


    But then, they banned television until 1999.



     

    posted by sydney on 12/20/2004 01:30:00 PM 0 comments

    Good-bye, Celebrex: It looks like Pfizer's arthritis drug, Celebrex, is about to go the way of Vioxx:

    Pfizer said yesterday that it would immediately stop advertising Celebrex, its best-selling arthritis pain reliever, to consumers after a study showed that high doses were associated with an increased risk of heart attacks.

    The suspension of advertising, which is indefinite, includes television, radio, newspaper and magazine ads and other promotions to consumers, a Pfizer spokeswoman, Mariann Caprino, said yesterday. Some magazine ads may appear for a few more weeks because of the long lead time of magazine advertising, she said.

    Pfizer appears to have had little choice in deciding to end the advertising campaigns. The Food and Drug Administration said Friday that it was considering regulatory measures that could include severe label warnings or even requiring that the drug be withdrawn in the United States.

    .....Still, Pfizer has no plans to stop selling Celebrex, Pfizer chief executive, Henry A. McKinnell, said in an interview on "This Week," on ABC Television. For many patients, Celebrex works better than other pain medications, Mr. McKinnell said.

    The company will work to inform doctors of Celebrex's potential risks, he said.

    "We're leaving Celebrex on the market because it is an appropriate option for many, many patients," Mr. McKinnell said.

    But George Sard, chairman of Citigate Sard Verbinnen, a crisis communications firm, said Pfizer was making a mistake by trying to keep Celebrex on the market.

    "Pfizer will inevitably have to recall Celebrex," Mr. Sard said, "and I believe they are making a strategic error not doing it immediately. Their current position is untenable - and the price of waiting will be increased legal, financial and reputational costs."


    Pfizer's drug reps have been working hard since the removal of Vioxx from the market to assure physicians that Celebrex is safe and has none of the cardiovascular risk associated with Vioxx. They've also been saying that it will never be taken off the market. Could the company's resistance be due more to pride than sense?

    The "crisis consultant" is right. At this point, the legal risks of prescribing the drug are untenable. It may be a beneficial drug for a subgroup of people, but once the media has been saturated by reports of its risks, no matter how exaggerated those reports may be, patients see it as a harmful drug. I've had far too many patients who are too willing to believe that their estrogen replacement therapy or their Vioxx caused their heart disease rather than their aging vessels. It's impossible to convince them otherwise. It will be the same with Celebrex. And if I can't convince my patients, what chance do I have of convincing a jury?

    UPDATE: Derek Lowe agrees, Celebrex is toast.

     
    posted by sydney on 12/20/2004 08:32:00 AM 0 comments

    Sunday, December 19, 2004

    Art History Lesson: Durer's pain.
     

    posted by sydney on 12/19/2004 10:26:00 PM 0 comments

    Bears of Little Brain: The Poohsticks phenomenon.
     
    posted by sydney on 12/19/2004 10:21:00 PM 0 comments

    Guggulu Warning: Watch out for Ayurvedic herbals:

    In March, the Medicines and Healthcare products Regulatory Agency (MHRA) reported a case of lead poisoning in a patient who had taken the Ayurvedic medicine Muhayogaraj Guggulu to treat rheumatoid arthritis. Yesterday’s report, published in the Journal of the American Medical Association, found that this product purchased in the US was one of the most heavily contaminated of all.

    Taking it as recommended would expose a patient to at least 10,000 times the recommended daily limit for lead, 1,000 times the limit for mercury, and 1,000 times the limit for arsenic, a team from Boston University and Harvard Medical School report.


    The study found that one out of five Ayurvedic herbals from South Asia sold in Boston had harmful levels of lead, mercury, and/or arsenic. That's rather high.
     
    posted by sydney on 12/19/2004 10:01:00 PM 0 comments

    Virtual Museum Watch: Medicine man a "cross-section of extraordinary objects... ranging from diagnostic dolls to Japanese sex aids, and from Napoleon's toothbrush to George III's hair. It also features 'The Phantom Museum' - a specially commissioned film by the Brothers Quay."
     
    posted by sydney on 12/19/2004 09:48:00 PM 0 comments

    Flu Vaccine Update: Minnesota has surplus flu vaccine, while here in Ohio we still have none. It's beginning to look as if some state health departments were much better prepared for this than others.
     
    posted by sydney on 12/19/2004 09:37:00 PM 0 comments

    Selling Hope: Our local Sunday paper had a large, above the fold article on a local man with Lou Gherigs disease who is spending $20,000 to go to China for fetal cell therapy:

    He has to gasp before attempting to string together short staccato words to form the simplest of sentences, explaining that he is not going to China in search of a miracle cure.

    He has no illusions of rising from his wheelchair once the fetal cells are inserted through a long needle after a small hole is drilled in his forehead.

    Instead he is hopeful the injection of millions of olfactory cells harvested from the nose of an aborted fetus will somehow help his own body regain control of weakened muscles or at least slow the disease.

    ``We know I can't wait,'' he said. ``I know this is not a sure thing. But I have to try it.

    ``If I come back halfway better, it will be the best Christmas present I could ever have."


    The article makes much of the man's Catholicism, even including a close-up picture of his rosary hanging from his wheelchair:

    There was a time when these devout Catholics would have bristled at such a procedure, but that was before the reality of his illness became clear.

    Having been reared in Cleveland-area Catholic schools, Winchester still believes abortion is wrong.

    But given that the Chinese government encourages abortion, he says, the fetal cells necessary for this particular procedure are readily available there.


    Does that mean it would also be acceptable to get organs from executed Chinese?

    You can't blame the family for their desperation, but it's hard not to look askance at the middleman who has been supplying the patients for the Chinese surgeon - for a fee:

    The couple turned to a retired art dealer from Dodgeville, Wis., who has become the arranger of such trips for the Chinese doctor, neurosurgeon Huang Hongyun.

    Stephen Byer -- who says his adult son underwent the treatment and has seen his ALS stabilize -- helps schedule Huang's foreign patients and collects a fee for the $20,000 procedure.

    Some medical experts in this country remain skeptical of the treatment because the Rutgers-trained Huang has never conducted clinical studies.

    But that said, Byer noted, there are still more than enough people willing to give it a try. He said there are currently 1,200 patients lined up to travel to China through February 2006.


    As for the Chinese neurosurgeon, his work also seems a little fishy:

    Huang Hongyun, a mild-mannered 48-year-old doctor, gives hope to thousands of paralyzed or degenerating patients around the world. His results are often lauded as miraculous. His surgery schedule is booked for the next 12 months, with more than 1,000 patients -- including some from Canada -- eagerly awaiting their chance to fly to Beijing for his treatment.

    Yet the world's top medical journals won't publish his studies. Many Western neurologists have criticized his techniques. And he is unwilling to submit to a randomized trial of his methods.

    'I've sent papers to more than five journals, but they are always rejected,' Dr. Huang says indignantly. 'I'm angry about this. I believe it is unfair for editors to do this. If I was American, they would publish it. But I am Chinese, so they don't publish it.'

    One of the most controversial aspects of his surgery is the source of the cells he injects into the spines and brains of his patients. They are taken from four-month-old human fetuses -- among the millions aborted every year in China. In each operation, the patient is injected with at least a million cells harvested from olfactory bulbs inside the noses of the fetuses.


    Why would he need to use the olfactory cells of sixteen week old fetuses when olfactory cells are readily available from adults? And using the patient's own cells eliminates any concern about tissue rejection, which is a problem with fetal cells. You have to wonder if he's really injecting anyone with anything.

    His only published study appeared in the Chinese Medical Journal and went like this:

    The surgical procedure, which the paper described in detail, is essentially to perform a laminectomy at the site of the damage, open the dura, and inject ensheathing cells....He then injects 50 microliters of a cell suspension, approximately half a million cells, into the spinal cord, next to the ends of the lesion.

    Before the operation, patients were assessed for degree of paralysis and for sensitivity to light touch and to pinpricks, following an international standard. They were reassessed between two and eight weeks later. The paper claimed that patients made significant if relatively slight improvement in these measures. However, the data are scanty and impossible to evaluate reliably. The subjects are grouped by age but not differentiated further, not even, say, into male and female. The paper describes no individual cases. It offers no before and after scores, just degrees of improvement, and these as averages within each age group. It says nothing about possible deleterious effects, not even that there were none. It reports no long-term outcomes.


    The author of the Technology Review article attended a lecture by Huang and was less than impressed:

    The title of his talk was “Olfactory Ensheathing Cell Transplantation for Amyotrophic Lateral Sclerosis.” ALS is the devastating nerve disorder better known as Lou Gehrig’s disease. (The accounts in the Scientist, Time Asia, and the Chicago Tribune had mentioned Huang’s turn to ALS.) Huang offered some minimal PowerPoint slides. His summary claim, at beginning and end: “OEC transplantation is safe, feasible, and rapidly improves partial func-tion. Results are observable in two or three days, and improvement continues for two to three months. The mechanism is unclear.” However, his data were shockingly thin—indeed, insultingly so, I came to think. He finished up with half a dozen brief, blurry before-and-after videos of six of what he said had been a set of eight ALS patients, newly able to walk, or to stand, or to sit up, or to move the tongue enough to talk, if indistinctly. Each was followed by charts depicting nerve function before and after the transplant surgery.

    His audience treated him with caution and courtesy, while its skepticism and impatience steadily increased. Much of the simplest factual information—pre-data, one might call it—was missing. Halfway through the question period, I asked several questions. When did his work with ALS patients begin? January 2003, he answered. But the videos carried dates, and these were as recent as mid-August 2004, just three weeks earlier. How many patients had he treated? He gave no clear answer; after follow-up questions from others, the likely number seemed to be 10 or 11—until he said there had been “about 40.” Did they all get fetal cells? No answer.

    As the questioning went on, problems with Huang’s methodology seemed to emerge, chiefly the lack of rigorous pre- and postoperative evaluation of patients’ functioning, the lack of controls, and, above all, the total absence of follow-up beyond a few months.


    Two physicians from Miami went to China to observe his technique, and also noted problems:

    Guest and Qian during their visit examined 12 spinal-injury patients. They formally assessed six of them before and after and indeed observed four operations. They acknowledge that some of the patients demonstrated a degree of modest improvement in motor and sensory function—and that the improvement occurred surprisingly soon. However, two patients showed “wound breakdown,” one of them suffering “a reduction in leg function.” A third patient came down with meningitis. “The Chinese clinicians did not record these complications in the medical record,” asserts an unpublished report by the Miami Project. Although Guest and Qian did watch surgery and observe patients, they were not allowed into the labo-ratory where the cells for transplantation were prepared and had no way to know the content of the putative human fetal -olfactory-bulb cultures—not even whether the material transplanted actually contained ensheathing cells. Guest adds, “We did see one set of cultures that showed robust cell growth and morphology that could be ensheathing glia. They were very healthy cultures. We viewed them in Dr. Huang’s clinical office.” The chief problem they saw, however, was the lack of long-term follow-up, including full records of any adverse effects.

    And apparently, there are even worse potential complications:

    I saw Huang the afternoon of October 20, 2004. A correspondent from the Mobile, AL, Register, Karen Tolkkinen, was also in Beijing, Huang said; he was to treat several Americans with ALS that week, and one was from Alabama. That evening, he operated on Ronnie Abdinoor, a 47-year-old from New Hampshire. On October 29, Tolkkinen reported in the Register that Abdinoor had died.

    It's too late for the man in my newspaper. His flight already left for China. Will the newspaper let us know how he's doing in a few weeks, six months or a year from now?
     
    posted by sydney on 12/19/2004 09:35:00 PM 0 comments

    Christmas Tales: Found more of my favorite books, these all Christmas-themed. The The Huron Carol is the Nativity reframed as a Huron legend. "It was in the moon of wintertime, when all the birds had flown..." Hunters take the place of shepherds, chiefs from the West are the wisemen of the East, God is "mighty Gitchi Manitou," swaddling clothes are ragged rabbit fur, and the stable is a bark lodge. Even better, it's a real carol, written by seventeenth century Jesuit missionary Jean de Brebeuf who died in an Iriquois raid on the Hurons.

    And what is Christmas without a Tomie DePaolo book? He's got a way with multi-cultural tales, especially Christmas ones. From Mexico, The Legend of the Poinsettia, from Italy, The Legend of Old Befana, and from the American Southwest, The Night of Las Posadas. But my all-time favorite is another Italian tale, Tony's Bread, which tells the story of how our family's favorite Christmas Eve dessert, panettone came to be.

    And for adults, in the English tradition of Christmas ghost stories lives on in Robertson Davies's High Spirits. Another book I've read more than once.
     
    posted by sydney on 12/19/2004 05:19:00 PM 0 comments

    Favorite Things: Looking over all of those books piled about our house (which are now put away to ready the house for Christmas), made me think about some of my favorite books which do have a place on our bookshelves. Not long ago, Hugh Hewitt asked if there were any modern novels people would read twice. I can think of three, well, actually five but three of them are part of a trilogy. They are The Last Jew by Noah Gordon, The Baron in the Trees by Italo Calvino, and The Deptford Trilogy by Robertson Davies.
     
    posted by sydney on 12/19/2004 04:53:00 PM 0 comments

    Book Ends: Books have taken over our house. They're underfoot in the living room, piled up on the dining room table, and cluttering the kitchen. Not that we're all that erudite, mind you. Too many of those books are along the lines of Captain Underpants and the Big, Bad Battle of the Bionic Booger Boy for me to pretend to any high intellectual caliber on the part of my family. We're just sloppy. Part of the problem is that with a family of six, we just don't have enough bookcase space to hold all of the various books that come and go from the library. But a greater part of the problem, at least in my case, is that there rarely seems to be enough spare time to read all of them, especially the ones we buy. As a result, there are books scattered hither and yon that I 've started but have yet to finish. But there are advantages to living in a house with books scattered willy nilly, especially when those books have been chosen by someone else. It's like being in a bookstore. You can sample a little here and there from a wide variety of topics.

    First of all, there are the medical books that I've collected hoping to review, but haven't been able to devote the time needed to do them justice. For those who yearn for immortality, there's Fantastic Voyage : Live Long Enough to Live Forever by Ray Kurzwell, "inventor, thinker, and futurist" and Dr. Terry Grossman, director of a "leading anti-aging clinic." The book is part how-to manual and part review of things to come if anti-aging technology fulfills its promise. Suffice it to say, the state of the art isn't yet perfect. In a related vein, there's Coping With Methuselah: The Impact of Molecular Biology on Medicine and Society, a book I don't have lying around my house, but which was reviewed favorably in this week's New England Journal of Medicine, even though it was written by committee:

    The book is the product of the collaborative efforts of 17 scholars, including three medical scientists (Drs. William B. Schwartz, John T. Potts, and Alan M. Garber); a large team of reputable economists, most of whom are from the Brookings Institution; an ethicist, Alexander Capron, from the University of Southern California; and a journalist, Nicholas Wade, of the New York Times.

    To transform the diverse expert opinions into a coherent book, two meetings among the contributors were organized: a planning meeting, which was held at Stanford University in 2001, and a conference, which was held at the Brookings Institution in Washington, D.C., in 2002. In addition to these efforts to harmonize the experts' opinions, the editors have provided six of the book's seven chapters with accompanying detailed comments (which are sometimes as long as the chapters they complement). These have been written by other experts — in most cases, former discussants and opponents at the earlier meetings — which makes for particularly interesting and useful reading because of the diversity of opinions.


    Sounds wonkish, but that doesn't mean it isn't interesting.

    For those of us worried more about keeping pace with the present, there's Reversing Osteopenia : The Definitive Guide to Recognizing and Treating Early Bone Loss in Women of All Ages. Although it isn't at all clear that taking drugs for bone density values that are on the thin side of normal is of any value, the book has some common sense suggestions for exercise and diet that certainly can't harm.

    You've heard of PMS, and IBS, but have you ever heard of IMS? That's Irritable Male Syndrome, and there's a book on managing it: The Irritable Male Syndrome : Managing the Four Key Causes of Depression and Aggression. Apparently, it's causes run deeper than nagging wives and backseat drivers.

    Planning to treat yourself to a complete physical for the New Year? You might want to peruse Medical Tests That Can Save Your Life : 21 Tests Your Doctor Won't Order. . . Unless You Know to Ask. Most of the tests are not recommended for routine health screening, but the authors do make an attempt to help the reader decide if they are at higher than normal risk for the conditions in question. The most useful section of the book, however, may be the "how to approach the doctor" part.


    In the non-medical department , there's FBI Girl : How I Learned to Crack My Father's Code, a memoir of growing up in a Catholic FBI family. Then there's the fictional The Distance Between Us, a novel of love and intrigue in the Middle East, and Tearjerker, the tale of love and frustration in the publishing industry.

    Among the non-fictional/non-medical books I keep meaning to read are Swamp Doctor: The Diary of a Union Surgeon in the Virginia and North Carolina Marshes and The Voices of Morebath: Reformation and Rebellion in an English Village. The first is the Civil War diary of Dr. William Mervale Smith of the 85th New York Volunteer Infantry. The good doctor has a soul that is often "depressed and weighed down," as well it might be, for an upstate New Yorker transported to the swamps of the South. His entries are short on medical details, but long on complaints about the Army hierarchy and army life in general. Most interesting sampled piece so far: an appendix contains the complete written examination he had to take to become an Army surgeon, including his answers. (This question was puzzling: "Name the roots and grains from which alcoholic drinks are distilled in various parts of the world." He knew some, but not all. Left out the potato and sugar cane, but then he wasn't much of a drinker.) The second is a look at the life of an English village as reflected in the accounting books of its priest. It doesn't sound very interesting, but the story begins when the village - and its priest - were completely Catholic under Henry VIII and ends fifty-four years later completely Protestant under Elizabeth I. In between, they lost their monastery (no great loss, the parish church got the fancy windows), had to hide their valuable vestments so the Crown wouldn't take them, rebelled and lost their church bells, switched back to Catholicism during the reign of Mary and then found their Protestant inner selves again on Elizabeth's accession. Best slice so far: for some reason, the village didn't build a cucking stool for punishing women scolds until after the Reformation, even though the chairs were common in England throughout the Middle Ages. The author speculates that the absence of devotion to Mary and to Saint Sidwell, a local woman saint, eroded respect for women in the village, but perhaps women were somehow embolded by the Reformation, making the chair more of a necessity.

    The best books in our house belong to my husband. Washington's Crossing by David Hackett Fisher is eminently browsable and chock full of wonderful nuggets of information. The introduction alone, a lesson in the art history of the famous Washington Crossing the Delaware painting, is worth the price of the book. And the chapter on the Hessian mercenaries was absorbing, too. My husband's current bedtime reading is Napoleon After Waterloo: England and the St. Helena Decision, which confines itself to the time that Napoleon spent onboard the British warship The Bellephron awaiting his fate. Best slice so far: the lengths the Admiralty went to avoid British lawyers and advocates bent on enforcing habeus corpus for the benefit of Bonaparte. My husband's fictional reading includes two historical novels by politicians, given to him as a wry gift so he could compare their story telling abilities. One is The Hornet's Nest: A Novel of the Revolutionary War by Jimmy Carter. It doesn't have any good bits and pieces to report. It reads, well, like Jimmy Carter talks -didactic and boring. My husband, a die-hard liberal, agrees. He hasn't been able to get past the first chapter. The other book is Gettysburg: A Novel of the Civil War, by Newt Gingrich, a fantasy of Gettysburg in which the South wins. Maybe it's because Gingrich has a background in history, or maybe it's because he hired a professional writer to help him, but it's a tale told better by far than former President Carter's.

    And speaking of books written by politicians, here's one I have actually read and enjoyed - The Accidental Pope by Ray Flynn. Also co-written with a professional writer, it isn't great literature, but it's thought provoking. An ex-priest now a widower and fisherman with a family, ends up being elected Pope after a joke by a Cardinal gets out of hand. As so often happens when an outsider comes to town, much conflict ensues. It won't win any literary awards, but it is entertaining.

    Thus ends the Amazon Associate link-fest.
     
    posted by sydney on 12/19/2004 09:04:00 AM 0 comments

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