"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
Depressed? Too Bad: The British drug regulatory authorities have turned their attention from Paxil, to Effexor:
Yesterday, U.K. regulators said the drugs should not be prescribed for patients with mild depression and, instead, suggested doctors promote such options as counseling. The agency also called for stronger warnings about side effects after a drug is stopped.
Overall, the regulators found the benefits of antidepressants outweighed the risks in adults. But they also noted Wyeth's Effexor was linked to a higher rate of deaths from overdose than other drugs and the pill may cause heart problems.
As a result, U.K. regulators said Effexor should only be prescribed by specialists and should not be given to any patient with heart disease. Wyeth said it will challenge the agency's recommendations.
"We don't think there's any scientific basis for this decision," Joseph Camardo, Wyeth's senior vice president of medical affairs, said.
He said the number of patients who took an inappropriate amount of Effexor and experienced a heart problem was "fewer than a dozen." The number of Effexor patients who took an appropriate dosage and suffered a heart problem was fewer than worldwide, he said.
Does Effexor cause heart problems? It could, potentially. Here's a report of it interfering with an implantable defibrillator, but this review of the literature found little evidence of cardiac side effects.It probably isn't terribly toxic to the heart, but it might increase the risk of heart problems a little bit. Hard to say. Guess we'll have to wait until the data the British have is made public.
posted by Sydney on
12/07/2004 11:58:00 AM
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Celebrex Gets a Reprieve: Celebrex, a close relative of Vioxx, is managing to hold its own in the heart safety contest:
For this latest study, researchers at the University of Pennsylvania School of Medicine reviewed records on 1,718 people who had been admitted to 36 hospitals with a nonfatal first heart attack, and compared them to 6,800 people who had not had a heart attack from the same geographical area.
People who had taken Vioxx had a 2.72 times higher chance of having a heart attack compared to people taking Celebrex.
People taking Vioxx also had a higher risk for heart attack than did patients taking nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen and naproxen.
"It appears that not all cox-2 inhibitors are the same with respect totheir effect on heart risk," said Stephen Kimmel, an associate professor of medicine and epidemiology at Penn. "We can't exclude a small increase in risk from Celebrex. We just didn't see one here."
Hard to say how much significance to place on this study without knowing how well the researchers controlled for differences between groups of people. Was there something about Vioxx users (aside from Vioxx) that made them more vulnerable to heart attacks than the Celebrex users? (age, smoking habits, cholesterol, etc.)
posted by Sydney on
12/07/2004 11:42:00 AM
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Somehow every baby I know has gotten a flu vaccine but many of my elderly patients, (who are, by the way, much more vulnerable to the flu as a whole) have gone wanting. posted by Sydney on
12/07/2004 11:30:00 AM
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Role Model: Anyone out there whining about all the holiday pressures, please take a moment to think of this guy. Wounded in a terrorist attack and he still manages to pass his medical exams. posted by Sydney on
12/07/2004 11:22:00 AM
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Resources are limited. Ditto for government budgets. And so choices have to be made, notwithstanding the dual fictions that health care is "free" and that those who need it will not be denied. Someone has to be denied, and guess who that is increasingly: the elderly. Why "waste" expensive procedures and devices and medicines on someone who is going to some eternal reward relatively soon when a far more deserving (read: politically defensible) patient also is on the waiting list?
Alas, it does not, it will not, it cannot stop with the elderly. "Free" health care in Canada means that waiting lists are long, patients deteriorate while waiting, such "cheaper" devices as plastic artificial knees are used in place of aluminum ones, and those who can travel and pay for medical care go to the U.S. And those who cannot? Well, they suffer. As day follows night, health care will be denied the mentally ill, the desperately tiny prematurely born, those whose prospective "quality of life" in someone's politicized view will be inadequate. That is the tragic road toward which nationalized compassion inexorably will lead. This is not because the system is afflicted with correctible inefficiencies or because budgets are not fully funded or because doctors/hospitals/pharmaceutical producers/insurers/bureaucrats/name your goblin are greedy/corrupt/uncaring.
It is because "free" health care cannot overcome the basic and eternal condition of mankind: Wants exceed resources.
Hope for Spinal Cord Injuries: And it isn't from stem cells, but from polyethylene glycol, better known as anti-freeze:
PEG acts as a kind of 'molecular Band-Aid,' Borgens explained. Injury causes 'holes' in nerve cell membranes in the spinal cord. PEG seals the hole, sort of the way liquid soap creates a film on the round part of a bubble wand. That patch lets the nerve cell reconstruct itself. PEG is flushed out of the body within about two hours, Borgens said.
Researchers previously had tested PEG on guinea pigs. Beginning in 2001 and through last year, research was conducted on 19 dogs that sustained severe spinal cord injuries. All of the injuries occurred in accidents, Borgens emphasized -- none of the dogs was deliberately injured for the research.
In each case, the dogs were taken to their veterinarian soon after the injury and then referred to one of the participating universities.
It will be a while before the stuff can be tested in people, but for now, it looks like life might get a little better for dachshunds. posted by Sydney on
12/06/2004 08:57:00 AM
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Ukrainian Medical Mystery Update: Saturday's New York Times had an detailed synopsis of Ukrainian opposition leader Viktor Yushchenko's illness:
He arrived first on Sept. 10, severely ill and unable to walk, after five days of terrible abdominal pain. Initial testing showed that he had a high white-cell count and elevated liver and pancreas enzymes, suggesting inflammation of those organs. His tests were negative for all the obvious possibilities, like hepatitis caused by a virus.
Scans showed that his liver, pancreas and intestine were, indeed, swollen. Internal examinations of the intestine using an endoscope found he had ulcerations - essentially bleeding abrasions - of the stomach and throughout his intestine and bowel as well. Ulcers are typically not spread out in that way.
The doctors gave him supportive care, like intravenous fluid and a restricted food intake to rest the digestive tract. As he gradually recovered strength, he opted to get back to the campaign trail. Already, doctors noticed that he was developing odd lesions on his face and trunk.
Ten days later, the candidate returned, after three days of what he called excruciating back pain. Its source was again a mystery, since related lab tests and scans were normal.
The pain was so severe that doctors had to place a large intravenous line into Mr. Yushchenko's chest and essentially nearly anesthetize him with huge doses of opiates. Because opiates depress respiratory functions, his breathing rate slowed, and his vital signs had to be constantly monitored. More medicine would have required that Mr. Yushchenko be placed on a respirator, Dr. Zimpfer said.
....The issue has persisted because of the obvious disfigurement and discoloration of his face, which is swollen and pocked with large bumps and cysts, and is a dusky grayish color. The left eye is bloodshot and sometimes waters.
...The candidate refused a biopsy of his face - which doctors suggested to try to narrow down the causes - because he did not want to campaign with stitches. But dioxin and related toxic chemicals are detectable in the body years after exposure. Ms. Gerashchenko said tests for such substances had still not been performed.
High-dose exposure to a chemical would seem to be a reasonable speculation. His photographs are suggestive of chloracne. Too bad he's been too busy to get an adequate diagnosis. He must be a Type A+ personality. posted by Sydney on
12/06/2004 07:47:00 AM
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Serendipty: The flu vaccine shortage has been a bonanza for Kimberly-Clark's new anti-viral Kleenex, which is flying off shelves.
The Kleenex has a specially treated middle layer, containing citric acid and sodium lauryl sulfate, but as one microbiologist points out, just having the chemicals there doesn't necessarily make the tissue an effective virus killer :
"But let's say you have a large amount of mucus coming out of your nose, it is virtually impossible for the amount of citric acid and sodium lauryl sulfate in a tissue to diffuse through that and effectively kill all the virus in a particular sample."
In addition, the tissue must be wadded up rather carefully with the mucus inside before it is tossed in the trash can. Stuffing it back into a pocket is liable to spread the virus.
Also, for successful germ control, no mucus can touch the cold sufferer's hands. If it does, the virus can be easily transferred to a new victim either directly or indirectly. "So the concept is good, but the execution may allow for a limited effectiveness,"
The company claims that 99.9% of cold and flu viruses -- specifically rhinoviruses type 1A and 2, influenza A and influenza B and respiratory syncytial virus -- that are trapped in the treated tissue will be killed within 15 minutes.
A 99.9% kill rate seems pretty optimistic. Especially for the large boluses of mucous that come out of most people's noses when they blow them. posted by Sydney on
12/03/2004 08:46:00 AM
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Preparedness Update: Are we prepared for a bioterrorism attack? No. We've got stockpiles of supplies, but no way to distribute them. That should come as no surprise to anyone who has tried to get a flu vaccine this year. If distribution plans had been in place, the flow of vaccine from the manufacturer to the CDC to local public health departments and then to the high risk public should have been smooth. It wasn't, and hasn't been. Instead, we've had heads of local public and state public health departments stating publicly they have no idea if and when they'll get flu vaccine, and we've had elderly people standing in long lines at grocery stores and pharmacies to get vaccines.
Part of the problem may be understaffing, but a larger problem is that those who have been made responsible for bioterrorism response plans seem to have a mental block when it comes to taking the threat seriously. They're more concerned about familiar threats, such as influenza and antibiotic-resisitant bacteria:
...."I'm not downplaying five deaths from anthrax," Gensheimer said, "but we have 38,000 people dying of influenza each year."
Even in cases where vaccines and antibiotics are available, the supply of these medications is unreliable. "There have been shortages of several antibiotics," said Gensheimer. "It's a symptom of the whole system. We really are vulnerable."
"And people still don't have any clue what we're talking about when we say 'influenza pandemic,' " said Olson. The Spanish Flu of 1918-19 killed at least 25 million people worldwide in just those two years — more than died in World War I.
"The U.S. does not have a robust infrastructure for developing antibiotics — they're viewed as low-priced commodities," said Olson, "increasing reliance on off-shore manufacturers. The fact is we don't have the ability to ramp up to produce these drugs."
Not to downplay the here and now of those problems, but bioterrorism is a very real threat that we must take equally seriously. And while it's beyond the ken of public health departments to improve drug research or vaccine manufacturing methods, it certainly is within their ken to have distribution plans in place and tested, and to have the staff hired to implement them. (Or, at the very least, to have enlisted volunteers from the local medical community to help implement them.)
In many areas, mine included, efforts at bioterrorism preparedness have been non-existent. There needs to be a full accounting from each state and local health department to the federal government of how those bioterrorism preparedness funds were spent. And then, there needs to be some accountability.
The CDC and HHS have proven themselves inferior to the task of coordinating nationwide bioterrorism preparedness. Perhaps Tom Ridge's replacement at Homeland Security will be up to it. posted by Sydney on
12/02/2004 08:14:00 AM
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TennCare Update: Tennessee's experiment in universal health insurance coverage is still in limbo. The governor hasn't announced its complete elimination, but he has instructed its administrators to take steps to return to traditional Medicaid coverage.
Attempts at reforming rather than killing TennCare have been stalled by an advocacy group called The Tennessee Justice Center. Turns out, the attorneys at the Justice Center are making a killing on their lawsuits, all at the expense of TennCare:
The Tennessee Justice Center has received millions of dollars in court-ordered payments from TennCare, but the executive director of the nonprofit legal advocacy group says that isn't the motivation behind its legal challenges.
...In all, Tennessee has spent $11.3 million since 1998 to defend against class-action lawsuits from the center, paying both consultants and the public advocacy group's legal fees when they repeatedly defeat state attorneys in court, records show.
Sen. David Fowler, R-Signal Mountain and a member of the TennCare Oversight Committee, said the state has no choice but to pay the legal fees if a judge orders it.
``It's unfortunate that money is being spent on legal services rather than citizen services,'' Fowler said. ``But if the Justice Center wants to sue, we have to defend.''
All that money, and they're still running at a deficit. Maybe they need to cut their salaries.
Acknowledging Responsibility: From an editorial in today's New England Journal of Medicine (full text requires subscription):
Knowing that the media are primed and poised to focus on what we publish only increases the responsibilities of medical journals to maintain rigorous peer review and critical examination of how researchers interpret their findings. The media and the public see publication in peer-reviewed journals as validation of the research. Diligent reviewers and careful editors can identify mistakes, provide balance, and restrain overinterpretation. At this journal we go to great lengths to provide accompanying commentary from experts who can offer critical perspective and qualification. We urge the news media to try to do the same. Ironically, physicians tend to blame the journal when the media publicizes and misinterprets a research report.
Investigators see attention in the media as a valuable professional opportunity, as do their academic institutions, their funding sources (both public and private), and even their specialty societies, not to mention the pharmaceutical and medical-device industries. For private companies, publication and a positive press have cash value, which only further increases the need for peer-reviewed journals to remain critical and for policies such as ours that ensure that editors remain free of financial ties to those whose work they publish. Journals and those who write for them should be judged by the most critical standards of the medical profession, which has a memory that endures long after the flashes in the news media have faded.
They pat themselves a little too much on the back, but at least it's a start. Here's to the hope that future issues of the Journal will embrace an editorial policy of restraining statistical and rhetorical excesses in the papers they publish. It's not enough to provide accompanying commentary. The media and the public don't read those. They must also actually function as editors to the papers they publish and not fear telling an author, no matter how respected they are, that their analysis is flawed or their claims excessive. Once a paper gets published, it becomes gospel. The time to exercise editorial responsibility is before publication, not after. posted by Sydney on
12/02/2004 07:24:00 AM
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Redefining Normal: While Proctor & Gamble strives to redefine normal sexual appetites, some plastic surgeons and gynecologists seek to redefine normal genital anatomy. They're convincing women that they need surgery to make their genitals fit into skimpy bathing suits or to look like porn actresses, where evidently smaller is better. But other doctors, and porn producers, say that's bunk:
Some plastic surgeons, who note that there is no such thing as "normal" female genitals, are scratching their heads.
"It doesn't make a lot of sense to me, to be honest," said Dr. Young, of the American Society of Plastic Surgeons, who said he does a small number of labiaplasties in his practice in St. Louis. "I try to discourage most patients."
Even people in the pornographic film industry say there is no universal standard of beauty for genitals and that, in any event, men fantasize about the woman, not any one body part.
Mark Kernes, a senior editor with the trade magazine Adult Video News, said, "I really don't think most men care."
I think it's fair to say I've seen more than my fair share of women's genitalia, and it's true. There really is no "normal." They're as varied as any other part of the body - lips, eyes, ears, noses. Goodness. If the porn industry doesn't recognize a standard of beauty in that area, why should anyone else? posted by Sydney on
12/01/2004 08:40:00 AM
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Fast Tracking: The FDA has a testosterone patch that's supposed to increase women's libido on a fast track path, and its maker is calling in favors to get it approved quickly:
The Procter & Gamble Co., which is applying for approval of its Intrinsa testosterone patch from the Food and Drug Administration panel, confirmed yesterday that it has asked a medical society that it backs financially to recommend approval.
Although the patch has been granted 'fast track' consideration by FDA, some critics have said that side effects have not been sufficiently studied.
A New York University psychologist said that the patch is being 'treated like a female Viagra,' even though it causes a fairly drastic change in a woman's hormonal balance.
Why on earth would the FDA fast track a lifestyle drug? A drug for a terminal illness or a lethal infection, yes. But a drug that increases sexual appetites? Please. There's no reason to rush this to market without sufficiently exploring its side effects. Not to mention making sure its benefits are real and not a placebo effect.
And that bit about requesting that the finanically-beholden International Society for the Study of Women's Sexual Health lobby for its approval is just appalling. And to think that some drug company executives blame general practitioners for too early and indiscriminate mass use of new drugs. Right.
Proctor & Gamble have even created a disorder for their new product: HSDD, or "hypoactive sexual desire disorder." And how, pray tell, do we determine what is classified as hypoactive? Human sexuality runs a broad gamut. It's impossible to classify into normal and abnormal, except at the extremes. Just as it is with any other type of appetite. posted by Sydney on
12/01/2004 08:33:00 AM
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Against All Odds: Imagine, you're pushing 60, your youngest child is 44, you're divorced, and you've had your tubes tied years ago. And then, you discover you're pregnant with twins. What are the chances of that? Pretty slim, actually. The story doesn't quote any of the woman's doctors, so it could just be a hoax.
When I was a resident we had a woman who came into the hospital every couple of months or so claiming she was in labor with twins. Usually she'd show up in the emergency room and would be whisked up to labor and delivery. If the people working that night had never encountered her, they'd put on the fetal monitors and then get all worked up when they couldn't find a fetal heart beat. Then an emergency ultrasound would find no babies, and off she'd go to psychiatry.
I'd take this story with a whopping grain of salt.
UPDATE: From a reader:
I once had a patient who had, due to surgery,one tube and one ovary, on opposite sides of the pelvis. She'd been told by lots of doctors, me being the final one, that she'd never get pregnant.
Of course, she did; every year after that she gleefully sent me a birthday card--the little boy's birthday, that is. One of the happiest deliveries I ever had, back when I did OB.
Of course, this kind of thing can happen. But I'm still suspicious of the woman's story. Especially since there's nothing but her word to back it up. A comment from her doctor would make it more believable.
Federal and state investigators yesterday continued unraveling the mystery involving four Florida residents who appear to have contracted potentially deadly botulism poisoning possibly linked to anti-wrinkle injections at a Fort Lauderdale clinic.
....McComb, 47, and his employee Alma Hall were in serious condition at the Bayonne Medical Center in Bayonne, N.J., and breathing on ventilators, according to the Sun-Sentinel. It was unclear why the two were in New Jersey. The other two patients, also on ventilators, were at Palm Beach Gardens Medical Center in Florida.
...It is not known whether the four received Botox, another FDA-approved product or a counterfeit substance.
A hospital in the Netherlands -- the first nation to permit euthanasia -- recently proposed guidelines for mercy killings of terminally ill newborns, and then made a startling revelation: It has already begun carrying out such procedures, which include administering a lethal dose of sedatives.
Of course, the Netherlands isn't really the first nation to permit euthanasia. Germany, 1939:
The killing was usually arranged by the director of the institution or by another doctor working under him, frequently by innuendo rather than specific order. It was generally done by means of luminal tablets dissolved in liquid, such as tea, given to the child to drink. This sedative was given repeatedly - often in the morning and at night - over two or three days, until the child lapsed into continuous sleep. The luminal dose could be increased until the child went into coma and died. For children who had difficulty drinking, luminal was sometimes injected.
....Hans F. went on to tell how severely impaired the children were..."Those who were cleared for killing had prescribed for them much higher doses of luminal....Those children who were spastic,....had cerebral polio,....were idiots.....were unable to speak or to walk. And as one says today, allright, give them a sedative because they have been screaming. And with these sedatives...the child sleeps. If one does not know what is going on, he is sleeping. One really has to be let in on it to know that... he really is being killed and not sedated.
Initially limited to "mercy killings" at the behest of parents, Germany's child euthanasia program expanded within a few years to become automatic for babies deemed unlikely to live worthwhile lives - those with congenital deformities, cerebral palsy, Down's syndrome, microcephaly, hydrocephalous, and "serious hereditary diseases." Those categories soon expanded to older children and teenagers with the same conditions, and others - borderline mental impairments, juvenile delinquents, and of course, Jewish children, the ultimate "serious hereditary disease" of the day.
The Netherlands may not be in any immediate danger of descending from infant euthanasia to ethnic euthanasia, but once a society convinces itself that one type of life is not worth living, it's all too easy to convince itself that another type is equally unworthy. It's all just a matter of opinion. Today the unhealthy infant, tomorrow the hated minority. posted by Sydney on
12/01/2004 06:43:00 AM
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