Lexicillin QD

It's beginning to look a lot like...World Diabetes Day

I was walking past Union Square, here in NYC, last night where I saw mini-carnival of booths and a sound stage with music playing as part of the Novo Nordisk bus tour for promoting World Diabetes Day and also the insulin analogs they produce.

If you go to the WDD Web site, you see that they are funded by a host of pharm and medical device manufacturers. Their partners include Desert Dingo Racing. [The] "racing team that will compete in the Baja 1000 race with a World Diabetes Day car, raising awareness of diabetes and collecting donations for the Life for a Child Progam"[sic]. "Raising awareness" is the operative buzzphrase here (see below).

Unfortunately they had to compete with all the holidays installations that are coming alive with the TV crew coverage of the unveiling of the window displays at Lord & Taylor ("Christmas is the moment..." ...when you hit your credit limit),  and the ice skating rink at Bryant Park that I also walked past. I was on my way to a science writers meeting at a bar that was more crowded than normal, with plenty of sponsored food and drink.

Things haven't been so optimistic for other pharm companies with type 2 diabetes meds:

• Pfizer withdraws Exubera, the inhaled insulin substitute, from the market
• Byetta, the injected Gila monster saliva derived incretin mimetic, has been involved with some 30 postmarketing reports of acute pancreatitis according to the FDA
• A CNN analyst doesn't think problems that Novartis is having with its incretin enhancer Galvus will go away, and the he thinks that drug will never be approved in the US
   

Even the Empire State Building with be lit up with Blue/Blue/Blue to approximate the official diabetes blue color, Pantone 279 to be specific, in honor of today.

I think all these awareness raising efforts are losing their ability to compete with ubiquitous media messages in general. Some groups are saying that this is about about "medicalization" or disease mongering in order to boost profits for these companies.

As an example, Ed Silverman of Pharmalot reports on these stories:

Consumer Union "takes a whack at Glaxo’s Requip, the med for Restless Leg Syndrome" with this video. This prompted the head of the Restless Leg Foundation, a group with funding from Glaxo and Boehringer-Ingelheim, to urge its members to boycott Consumer Reports.

With all this awareness raising, it's no wonder we need more drugs for ADHD.

Update: NASCAR does diabetes, too. Their Web site says that this is their "first cause marketing program at this level of a NASCAR-sanctioned racing series." "Cause marketing" doesn't have the beneficent ring of "raising awareness." Call in the copywriters.

The flip flop rhythm of epidemiology

I think you can subtitle this post "The weakness of observational studies versus the randomized clinical trial (RCT)."

Do We Really Know What Makes Us Healthy? is the cover story by Gary Taubes published in yesterday's NY Times' magazine about the utility of epidemiology in providing the public with guidelines for maintaining health.

He starts off by talking about the hormone replacement therapy (HRT) controversy where HRT was supposed to prevent heart disease supported by observational studies. Then in the 90s, HRT was generally recommended for all women, but it was only was randomized clinical trials, such as WHI and HERS, looking at secondary and primary prevention respectively, that showed that HRT is not heart protective.

The point is women who take HRT are a special population, with unquantifiable characteristics, that tend to bias an observational study. You never know what you can miss, Taubes says. This confounding variables are better managed with a RCT. It also what's needed in attempting to prove causality.

I try to follow this up with further discussion.

UPDATE: The WSJ has an article published today Report Sheds Light on Hormone Therapy which suggests a reason why HRT might not have the cardioprotective effect for some women.

Researchers at University of Texas Southwestern Medical Center in Dallas have discovered that a compound related to cholesterol can block the hormone estrogen from performing functions in blood vessels that keep them healthy and free of disease that can lead to heart attacks.

This team found a molecule called 27-hydroxycholesterol, or 27HC, which is a byproduct created as the body processes cholesterol. The found in mice that 27HC and estrogen target the same receptors in blood vessels.

Following this hypothesis, premenopausal women are protected by the high levels of estrogen and low levels of 27HC, but during menopause, therapeutic estrogen is not effective because it can't compete with 27HC.

The researchers claim that this could account for the results found in the above-mentioned WHI and HERS studies.

Brooklyn woman diagnosed with West Nile Virus

A 41-year old Brooklyn was diagnosed with viral meningitis on Aug. 25, with later tests showing it was caused by the West Nile Virus. It is not clear if she contracted the disease here, since she had been traveling for 2 weeks before becoming ill. This is the first case to be reported this summer in New York.

Brooklyn Woman Has West Nile Virus - New York Times

You can see from the CDC's map 2007 West Nile Virus Activity in the United States (as of Sept. 4), there are human cases of infection through most of the US, with California have the greatest at 172 cases. The second highest is South Dakota with 81 cases, which seems high given the population of that state.

Technorati Tags: West Nile Virus, CDC, viral meningitis

Caution, but no conclusions about consumer risk from popcorn with diacetyl

This is an interview of the doctor who reported the case of the man who developed bronchiolitis obliterans and was also a heavy microwave popcorn eater. ("I am popcorn. It is my exclusive snack-food choice. I have been eating two to three bags a day for 10 years.")

Here's that last Q&A:

So what can you say about the risk of making butter-flavored microwave popcorn at home?

You have to be very careful about inferring a causal connection on the basis of a single case report. It may not be correct. We don’t know what the risk is to the occasional consumer of microwave popcorn. More work needs to be done to try to understand the exposures. I have not
banned the use of butter-flavored microwave popcorn from my home, but we certainly don’t use it every day. That’s just our habit – we were never big consumers of butter-flavored microwave popcorn.

 

I like the sentence about the uncertainty of causality. It applies to the vast majority of medical stories in the MSM.

Health Blog : Health Blog Q&A: Microwave Popcorn and Lung Disease

Technorati Tags: diacetyl, WSJ, microwave popcorn

COPD is "underdiagnosed, undertreated, and underfunded"

COPD is a disorder that persistently obstructs airflow in the lungs, and
is basically made up of 2 related diseases, chronic bronchitis and
emphysema.

You're in a constant battle to get enough oxygen into the blood, and your body had a hard time adapting to this. Think of an asthma attack that builds slowly over many years, and doesn't let up, and is not easily reversed.

The chronic obstruction can cause difficulty breathing,
wheezing and a chronic cough. Emphysema causes the destruction of lung
tissue, and those patients with this disease may require supplemental
oxygen to survive.

Reported in the latest issue of the Lancet by way of Reuters and SciAm: "The prevalence of chronic
obstructive pulmonary disorder (COPD) is higher and stages of
disease are more advanced than has previously been reported,
according to findings from the Burden of Obstructive Lung
Disease initiative."

This is a group of researchers from the Oregon Heath and Science University in Portland who examined the prevalence of COPD and its risk factors in about 9,000 adults who were at least 40 years and were living in 12 cities on 5 continents.

They discovered risk factors other than smoking, such as "
occupational exposure to gases, dust, vapors, and fumes;
exposure to outdoor and indoor air pollutants, caused by
burning organic matter for cooking and heating; and genetic
factors."

The article quotes one researcher who stated that COPD is "underdiagnosed, undertreated,and underfunded and neglected by the public, pharmaceutical industry and physicians alike when compared with other major killers, such as cardiovascular disease and stroke."

Other editorialists in the Lancet point out that the problem of evaluating new drugs for COPD is compounded by the practice of excluding patients with other illnesses normally associated with it, such as heart disease and diabetes. One solution might be to create a new umbrella term "chronic systemic inflammatory syndrome" which would include heart disease, hypertension, metabolic syndrome and some cancers.

In a way, it gives the general public a different in thinking about how these diseases are tied together. Certainly preventation and maintaining a healthy lifestyle should first include first examing genetic predisposition, both then also behavioral and environmental factors that contribute to general inflammation.

Advanced COPD a major disease worldwide: Scientific American

Technorati Tags: COPD, chronic systemic inflammatory syndrome

Smokers over the age of 55 were 50 percent more likely to develop dementia than similar nonsmokers

This is a study by the Erasmus Medical Center in Rotterdam, Netherlands, which followed nearly 7,000 people age 55 and older for an average of 7 years.

Smoking did not affect the Alzheimer risk for people who had the well-known gene that raises the risk of dementia called APOE4 or apolipoprotein E4. But those who did not have the gene had a 70% higher risk of Alzheimer disease.

The proposed mechanism for the dementia caused by smoking is multi-infarct dementia. that is, multiple small strokes that damage brain tissue.

I'm blogging about this story to highlight the fact that vascular disease is the most pervasive morbidity caused by smoking compared to lung cancer which is commonly thought of as the major risk to smokers. The other major consequence of smoking is chronic obstructive pulmonary disease (COPD) which tends to be underdiagnosed and undertreated.

Study finds smokers have higher risk of dementia - Yahoo! News

Technorati Tags: dementia, multi-infarct dementia, smoking, Alzheimer, COPD, lung cancer

WHO guidelines for avian influenza

I'm working at high speed today, so I'll just through out this link from Medscape and try to digest it later.

I recently finished "The Great Influenza" and "Demon in the Freezer," so I'm very much in the frame of mind of public health issues.

WHO Updates Guidelines for Avian Influenza Virus Management

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SiCKO: June 21st screening in NYC

I'll be attending a media screening of Michael Moore's SiCKO here in NYC this Thursday.

Cory was talking about how he was watching a copy on his laptop via a BitTorrent download. It's been popping up on YouTube, and now on Google video, all to the consternation of the Weinstein Brothers who helped produce this $9 million film.

It seems that the Treasury Department's Office of Foreign Assets Control, has sent a letter to Moore stating that his trip to Havana to film sequences demonstrating their healthcare system was under investigation for violating the US trade embargo with Cuba. Regardless of what further action might take place, Moore has suggested that the film may be seized as part of the investigation, the film is now in the public domain, if you want to find it.

But Moore is also using YouTube by creating a group where viewers can produce their own video responses, documenting their experiences with the US healthcare system.

This is an extended interview of Moore by Amy Goodman, and it probably is the best account of the beginnings for this film.

Warnings to Beckham about "economy class syndrome"

Not suggesting that David Beckham would be traveling in economy class when he does his trans-global commute between the England and US soccer teams. This BBC News report quotes an authority who feels it necessary to provide a warning to Beckham:

And aviation health expert Farrol Kahn warned: "It puts him in the high risk category for getting deep-vein thrombosis (DVT).

"That would ruin that leg for life - you simply could not use it again."

Beckham will also struggle to be at his physical and mental peak for England and Galaxy games in the immediate aftermath of long flights, according to Kahn.

Kahn told BBC Sport: "They've done studies of rapid deployment forces in the US military who have to fly long distances and then fight.

"In these young males, sprint times were reduced by 10%, lift and carry tasks by 9% and logical reasoning skills by 15%."

I tried to find the study cited about the military, but no luck. The phrase, "would ruin that leg for life," is not quite a medical assessment, besides, the worst sequelae of a DVT would be the fatal pulmonary embolism (PE), not mentioned by this expert.

This animation by Nucleus Medical Art demonstrates the creation of a clot just behind a valve in one of the deep leg veins, then the clot breaks loose and travels to the right side of the heart where it is sent into one of the lung blood vessels where it lodges and causes the fatal reaction known as a PE.

Coincidentally, I found this recent report, "Doctors Unite in Their Fight Against Economy Class Syndrome," which quotes experts at the 12th Congress of the European Hematology Association which just concluded its annual meeting in Vienna.

A recent WHO project (the WRIGHT, or WHO Research Into Global Hazards of Travel, project), the results of which are about to be made public, has shown that air travel is associated with a two- to threefold increased risk of developing blood clots in the legs, (deep vein thrombosis or DVT) or in the lungs (pulmonary embolism or PE).

The WRIGHT project included a study of nearly 2,000 patients with thrombosis and a survey of 9,000 frequent travelers. Among its conclusions, says Professor Rosendaal, is that in the eight weeks after a flight of more than four hours, the risk of thrombosis is increased two- to threefold. Overall, one in 4500 travelers develops thrombosis. For those individuals with a combination of common risk factors, such as oral contraceptive use and excess weight, the risk of developing blood clots after air travel may increase 100 fold. Professor Rosendaal: "Studies which  ncluded an experimental flight with volunteers showed clearly that immobility of passengers on long flights is the main cause of blood clots, but that cabin conditions such as low air pressure may also contribute."

Rosendaal is quoted:

"The risks of developing thrombosis when traveling are higher for people with certain common abnormalities in the blood, for women who use birth control pills, or people who use sleeping pills on a flight, as well as for people who are very tall, very short, or overweight."

I don't know if Beckham should consider being screened for a coagulopathy such as Factor V Leiden deficiency which is the most common hereditary coagulation disorder in the US, with a prevalence of about 5% in the Caucasian population.

This medical genetic testing Web site associated with the University of New Mexico, give the indications for testing in an article from 1997:

Who should be tested?  Indications include:

• Venous thrombosis or pulmonary embolism
• Transient ischemic attacks or premature stroke
• Peripheral vascular disease, particularly lower extremity occlusive disease
• History of a thrombotic event
• Family history of thrombosis or known factor V mutation in a relative
• Prior to major surgery, pregnancy, postpartum, oral contraceptive use or estrogen therapy if there is a personal or family history of thrombosis.
• Previous finding of activated protein C resistance by laboratory analysis

Notice that it doesn't mention anticipated long-term commute via aircraft across continents.

Another interesting list about the prevalence of genetic disorders in those who have had a venous thrombotic event:

Genetic Disorder	Prevalence among patients with venous thrombosis
Factor V mutation (APC resistance)	20-40%
Protein S deficiency	5-6%
Protein C deficiency	2-5%
Antithrombin III deficiency	2-4%
Plasminogen deficiency	1-2%
Heparin cofactor II deficiency	<1%
Unknown genetic defects	~40%

Andrew Speaker does a favor for public health

[The above is a montage of some of the photos from John Barry's The Great Influenza, which I just finished reading. Here, you can sense the urgency of the message from public health officials in 1918.]

In the Op-Ed piece from the June 2 NY Times, "Have Germs, Will Travel," Dr Kawamura suggests that the recent odyssey of Andrew Speaker has actually served an important lesson about the "growing problem of super drug-resistant tuberculosis, and the ease with which this deadly airborne disease can travel around the world."

But the reality is that Federal health officials are cutting back TB treatment programs for city and states as much as 25% over the next five years.

He feels that now, the main focus should be on developing tests that can evaluate drug resistance overnight. Currently, the Mycobacterium tuberculosis organism must be collected from the patient and then cultured for days. Being able to identify the critical gene mutations which confer drug resistance would accelerate this process of determining drug resistance.

The problem of drug resistant M. tuberculosis is pervasive and worsening:

In 2004, almost half a million of the more than 8 million cases of tuberculosis worldwide were resistant to the most potent TB drugs. And drug resistance feeds further drug resistance.

If you want to look at this from the broader context of the global transmission of infectious disease, with the inevitability of another influenza pandemic, you realize that Speaker's ability to circumvent public health officials alerts to foreign governments and custom officials needs to be addressed.