nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
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Wednesday, October 24, 2007

RECENT HEALTH NEWS

1. GAO investigators allege anthrax vaccine may be wasted. The AP (10/23, Sullivan) reports, "The government stands to waste $100 million a year if two federal agencies cannot agree to coordinate the use of a vaccine for the deadly anthrax virus." According to Government Accountability Office (GAO) investigators, "The departments of Defense and Health and Human Services (HHS) each purchase the anthrax vaccine, BioThrax." However, "much of the vaccine purchased for HHS goes unused." At present, "the Strategic National Stockpile has more than 520,000 doses of the vaccine -- worth $12 million -- that have already expired." Consequently, GAO has recommended that "the two departments...create a single inventory system for these drugs so [that] they are not wasted."

From Doc D: Note that GAO did a study of whether the anthrax vaccine was “safe” back in 1998. They called me to ask my opinion and I told them their analysis showing there were safety concerns was full of it. They went ahead and pushed the political agenda.

Times change, and so do the politics…

  1. FDA advisory panel recommends ban of some children's cold and cough medicines. In continuing coverage from previous briefings, ABC World News (10/19, story 2, 2:40, Gibson) reported, "Today, a government panel released its findings on children's cough and cold medicines. They don't work." On its front page, the New York Times (10/20, A1, Harris) added, "A Food and Drug Administration advisory panel voted Friday to ban popular over-the-counter cold products intended for children under the age of 6." According to the panel, "there was no proof that the medicines eased cold symptoms in children, while there are rare reports that they have caused serious harm." Should the FDA adopt this recommendation, the Times noted, it "could transform pharmacy shelves and change the way parents cope with the most common illness in young children." However, "manufacturers said [that] they would fight the new recommendations." Linda Suydam, president of the Consumer Healthcare Products Association, the drug industry's trade group, stated, "We believe these products will remain on the market." Dr. John Jenkins, director of the office of new drugs at the FDA, said, "We need to go back and review all these recommendations that we heard today and decide what the path forward might be." The agency could take several years to make a ruling in this matter. While the FDA typically adopts the advisory panels' recommendations, it is not required to do so.

From Doc D: I don’t know what you all did with your kids. Lydia and I used these drugs, and I don’t think the kids suffered. Note that we’re talking about the youngest age groups here. I agree that there is no good scientific data to say whether these drugs are safe in this age group, or what the real dose should be. The doses have been traditionally extrapolated from mg/kg data in older age groups. ALL of these drugs, to my knowledge, do not alter the severity, duration, or recovery from the illness for which they are prescribed. To be honest, I’ve used Dimetapp when one of the kids was fussy with a cold and couldn’t sleep: it helped them get their rest (and me to get mine).

Scientifically, these drugs reduce the symptoms of minor illness for a short period. They wear off, and there is habituation with continued use (the patient’s body “get’s used to” the drug and it doesn’t work as well.) You have to use these things with circumspection…and common sense.

I think many of the cases of severe side effects were due to unpredictable allergy, or overdosing (high single dose, or many repeated doses), or idiosyncratic reactions, or it had nothing to do with the cold medicines.

NOTE: For those of you who haven’t figured it out yet, my opinions are mine only, and do not represent any policy of the medical profession, drug companies, the Dept of Defense, any organization, or my beautiful and intelligent spouse…

D

Friday, October 19, 2007

IS THE PAP SMEAR ON THE WAY OUT?

I couldn’t let this one go by without a couple of observations (for the females). First, this data does not mean that you can stop getting your Pap smear. There are some minor issues with the experimental design, and the interpretation of the results, but the HPV test looks like a good “adjunct” (i.e., helpful when done also) test. It is not “standard of care,” at least yet. If anybody would like to get into to the weeds on this study, let me know.

This is another of those “get it done” situations in preventive medicine (like the flu shot*). In my 32 year career, nothing is more tragic than a woman with cervical cancer. This disease takes years and years to develop, it is so slooooow. Many, if not most, of the cases come from not getting Pap, blood test…or both (preferable), because the cancer can be detected waay before it fully develops.

Even more tragic is that cancer in a woman in her 20’s, because she wrongly assumed that cancer is for old folks only.

D

JAMES J DOUGHERTY, MD, MPH

*By the way, Flumist (the nasal spray) is just as effective as the shot, if your clinic or doctor offers it. Contrary to rumor it doesn’t cause the flu…it can give you a snotty nose for a day or two. And remember, both methods do not “take” in everybody (actually only 3 out of 4), we’re just looking for enough herd immunity to stop the spread of the disease. Flumist is an “attenuated” form of the live virus. Ingenious stuff: it was created by selecting for a genetic strain of the “real” flu virus that can only grow in low temperatures, like the nasal mucosa (but not in the body…or lower respiratory tract). So you get the immune response, but not the disease. Neato.

HPV test may diagnose cervical cancer more accurately than Pap smear, studies indicate. The CBS Evening News (10/17, story 3, 1:40, Couric) reported, "Doctors are telling us tonight [that] a new test could replace the Pap smear for detecting cervical cancer." HealthDay (10/18, Gordon) adds, "A test to detect human papillomavirus (HPV) -- which causes most cervical cancers -- was far better than the standard Pap smear at catching malignancies," according to two new studies published in today's issue of the New England Journal of Medicine. HealthDay continues, "Pap tests have been the standard screening test for cervical cancer for the past 60 years. More recently, the liquid-based or thin-smear Pap test was developed, and it was initially thought that this newer technology would offer significant advantages over the traditional Pap test." But studies have not shown that the newer Pap test is significantly better. Since "most cervical cancers are caused by HPV, the test to detect HPV infection is also an option for screening in addition to the Pap test." The studies published today sought to compare these tests. In the first randomized test, MedPage Today (10/18, Smith) notes that Marie-Hélène Mayrand, M.D., of McGill University in Canada, and colleagues, "assigned 10,154 women, ages 30 to 69, to one of two groups -- a 'focus on Pap' group, which got a Pap smear followed by the viral test, and a 'focus on HPV' group, which got the HPV test first, followed by a Pap smear." The trial lasted from September 26, 2002 through February 3, 2005. They "found that the viral test...correctly identified cervical intraepithelial neoplasia (CIN) of grade two or three 94.6 percent of the time, compared to 55.4 percent for the Pap test." However, "the specificity of the viral test was 94.1 percent, compared to 96.8 percent for Pap testing." For the second study, conducted between May 1997 and November 2000, "Swedish researchers randomly assigned 12,527 women ages 32 to 38 to get a Pap test (and form a control group) or a Pap test combined with a test for...[HPV] using polymerase chain reaction." They found that "[a]t baseline,...the proportion of women in the two-test group who had CIN2, CIN3, or cancer was 51 percent higher than among the women who only got the Pap test." However, "at the subsequent screening, following treatment where appropriate, the rate in the two-test group was 42 percent lower than in the control group." The researchers attributed "[s]ome of the differences" to "over-diagnosis at baseline."

Wednesday, October 17, 2007

RESISTANT STAPH SPREADING! YIKES!

Note: If you don’t want to get this medical stuff, a quick reply won’t hurt my feelings (got your flu shot yet?).

Before we “scare ourselves to death” (as John Stossel says), it’s worth noting that this infectious agent, and its resistance, was a problem back when I was in medical school. We thought doom was just around the corner THEN, because methicillin was the toughest bug-fighter we had. To say that we now have data on how often MRSA infection occurs does not necessarily mean that it’s growing rapidly in incidence…it could also mean that we just did not have data, until now, that it’s always been with us to this extent (the “one data point” problem). We also have multiple generations of new drugs since I was in school: they have their day, and then fade, as resistance develops.

Note, it is primarily a problem in “healthcare settings”: I’ve always told people that hospitals are where the sick people are, and…so are their germs. Unless you want to sterilize hospitals with poison gas continuously, this will always be the case. Every hospital and clinic gets “inoculated” with new pathogens every day.

Sixteen thousand deaths is a lot, but needs to be put in context. In a bad year for influenza, we see up to 100,000 deaths. Cancer is down, heart disease is down—so, what’s going to take their place? MRSA is spread by contact, so watching students holding a vigil outside the school, holding hands (Lydia noticed this on TV), makes me wonder if the organizers brought along enough hand sanitizer for the participants.

I don’t disagree that this data should be a “call to action”. But, put it on the list with the other million things we should act on…and make your choice. Sanitation and infection control can be improved in some hospitals, but the only other choice we’ve had for the last five decades is to try to stay ahead of resistance by producing new agents. With the expense of developing new drugs skyrocketing ($1-2B), and the time it takes for approval growing (10-15 years), we may lose the race at some point: this is a Government Regulation problem, and I doubt more regulation will solve it.

Need a scapegoat? (it’s the American Way): All the people that went to the doctor insisting on a penicillin shot for a cold/sorethroat/flu forty years ago, and the doctors that gave in, and administered it (some of the most pissed off patients I’ve ever treated were the ones I told didn’t need an antibiotic). There is less of this today, but the damage is done, and we do need antibiotics.

Heavy pressure on a bacterial population leads to mutation…basic biology.

Drug-resistant staph infections may be spreading, study indicates. The CBS Evening News (10/16, lead story, 3:20, Couric) reported, "We're beginning tonight with a threat to our health that doctors say could be at least as deadly as AIDS: A staph infection resistant to antibiotics." NBC Nightly News (10/16, lead story, 2:20, Williams) added, "Tonight, a teenager in Virginia is dead. His family says [that it is] the result of a staph infection that resists antibiotics." Currently, "21 schools are closed because of it, and across this country,...awareness of this danger is now on the rise because it can be a scary, indiscriminate and silent killer, and it's often discovered when it's too late." The New York Times (10/17, A14, Sack) notes, "Nearly 19,000 people died in the United States in 2005 after being infected with virulent drug-resistant bacteria that have spread rampantly through hospitals and nursing homes," according to a study published in today's issue of the Journal of the American Medical Association. The study was performed by CDC researchers, and is "the most thorough study of methicillin-resistant Staphylococcus aureus' (MRSA) prevalence ever conducted." The CDC estimates that "MRSA, which was first isolated in the United States in 1968, causes 10 percent to 20 percent of all infections acquired in healthcare settings." The bacterium is "[r]esistant to a number of front-line antibiotics," and "can cause infections of surgical sites, the urinary tract, the bloodstream, and lungs." Because the infection is treated by delivering other drugs intravenously, health officials are concerned "that overuse will breed further resistance."

D

JAMES J DOUGHERTY, Brig Gen, USAF (Ret)

Monday, October 1, 2007

GROUND BEEF RECALL

News report below on the ground meat recall. As Owen can tell you, the rise of giant processing plants that provide food products to widespread areas of the nation has magnified the impact when improper processing produces a hazard. However…it’s worth noting that 22M pounds of beef caused 25 people to become ill: that’s about 1 person per million pounds (note that reports have said that most of the beef has already been consumed). I suspect that the rate of illness due to improper cooking, or improper storage, is probably hundreds of times greater. Most E. coli strains are harmless, and the ones that aren’t usually cause non-serious illness. The people who get seriously ill may have something else going on: oddball strain, multiple bugs, defective immunity, etc.

In any case, nobody wants bacteria in their food (but, there used to be an FDA standard for the allowable percentage of insect parts in grain products, like flour…maybe there still is).

Before you toss out everything, note that most of this product was pre-formed 10# boxes, and in other reports all the cases of illness were in the NE (making me suspicious that the contamination occurred AFTER the product left the plant). But it’s worth a check of the freezer… How you tell whether it’s Topps, I don’t know.

D

Ground beef recall expanded. In continuing coverage from a previous briefing, ABC World News (9/30, story 5, 0:30, Harris) reported, "The recall of ground beef from the Topps Company has grown to almost 22 million pounds. And it now includes all packages dated between September 25th this year and next year. Investigators say the meat may have made at least 25 people sick in 8 different states." The AP (10/1) adds, "All recalled products also have a USDA establishment number of EST 9748, which is located on the back panel of the package and-or in the USDA legend," according to the company. "The U.S. Department of Agriculture said Friday it had suspended the grinding of raw products at the Topps plant after inspectors found inadequate safety measures." And, USA Today (10/1, Weise, 7A, Sternberg) notes, "Most of the recalled products are 10-pound boxes of pre-formed hamburgers sold to institutional customers such as restaurants, hospitals and schools. However, some are 1.5-, 2- and 3-pound boxes that consumers might have purchased." USA Today continues, "The boxed, frozen hamburgers were distributed to retail grocery stores and food service institutions throughout the USA." While most of these products may have already been consumed, Topps said that it is "'imperative that consumers look for these products in their freezers,' and if they find them, dispose of them immediately." HealthDay (10/1) also covers the story.

Doc D

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