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December 11, 2006

Gilead in Trouble over HIV Drug Marketing

by @ 3:08 pm.  Filed under Pharma News, Pharma

Seems Gilead may be in trouble over off-label marketing of its HIV drugs. The practice of prescribing drugs for off-label use is legal but the marketing of drugs to doctors for off-label use is prohibited.

MercuryNews.com | 12/07/2006 | Gilead gets subpoena over HIV drug marketing:

Recently Intermune agreed to pay $36.9 million to settle charges related to off-label marketing efforts related to its drug Actimmune. It is reported they were touting its use in a fatal lung disorder and it is only approved for treatment of a bone disorder. Scios a division of Johnson & Johnson is also under investigation related to their drug Natrecor.

I know some folks who think that it should be illegal to prescribe drugs for off-label use. I tend to think the present system works but there is a need to make sure drug companies aren’t pushing the limits in terms of what their rugs can be used for. I don’t want to take away the ability of doctors to prescribe what they deem best for their patients and this is particularly true in the area of oncology.

One line of defense that needs to be worked on is doctors reporting of improper marketing efforts by companies. I have a suspicion that it occurs more often than many think and that it is just ignored by doctors instead of being brought to light. I know this comes up on occasions and is talked about in corporate meeting rooms but only behind closed doors and usually in the content of how far can we push this without getting caught. This problem is one of those “dirty little secrets” that exists and needs to be dealt with.

Other Resources

Drug Injury Watch: Off-label Use / Prescribing

Off-Label Imbroglio Latest Concern for Drugmakers

Genentech gets subpoena regarding drug marketing | The San Diego Union-Tribune
When Doctors Go Off-Label - Forbes.com

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    E. Coli Outbreaks and Food Safety

    by @ 12:56 pm.  Filed under Health News, FDA

    Maybe it is just coincidence but we’ve now had three major outbreaks of e.coli O157:H7 since Sept 2006.

    1. Bagged Spinach in western states killed 3 and sickened at least 199
    2. Taco Bell on East Coast in NY, NJ, and PA from green onions/scallions: 62 sick, 49 hospitalized
    3. John’s Taco in Iowa 14 hospital, 36 sickened and this is still developing

    Here are the FDA press releases on the first two incidents:

    FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach–Update October 4, 2006
    FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach–Update October 12, 2006
    FDA Investigating E. Coli O157 Infections Associated with Taco Bell Restaurants in Northeast
    UPDATE: FDA Investigates E. Coli O157 Cases Associated with Taco Bell Restaurants

    The most recent is from a Taco Johns (not associated with Taco Bell) in Iowa and the source of the problem has not yet been identified. I would not surprise me though if it ends up being green onions also and maybe from the same source.

    14 hospitalized after dining at Iowa restaurant; E. coli suspected - CNN.com

    This brings the total to almost 200 sickened and more than 63 hospitalized in the past four months due to e. coli. The CDC states that 61 deaths occur each year due to e coli. I think just about anyone would come to the conclusion that there is likely a problem and some changes need to happen.

    I should point out that e. coli is found in the human gut and is normally present and does not normally cause problems. However, this particular strain O157:H7 is particularly virulent and affects people but the worst effects are seen mainly in the elderly or the young. This strain comes primarily from cattle and is found in cattle feces. This can get into water supplies and if that water is used for irrigation, it can lead to contamination. Another problem is that bacteria can form biofilms which are practically impossible to wash off.

    There are estimates that tens of thousands of people are sickened each year due to food based illness but the problem is very much under estimated mainly due to sickness not being reported.

    The authority for foods can be broken down into meat and poultry which is inspected by the US Dept. of Agriculture (USDA) and other foods which fall into the jurisdiction of the Food and Drug Administration (FDA). A major problem is that the FDA not set up to do field testing and monitoring.like the USDA does with meats. For example, the USDA has 7,000 inspectors inspecting 6,000 plants daily whereas the FDA has only 800 for food. Inspections of food processing plants which fall within the FDA’s jurisdiction are inspected only about once every five years!

    While I’m focusing on e coli here, but there are other concerns such as salmonela, hepatitis and other food-borne illnesses.

    All of this has lead to the call for a new agency. I’m not sure if that is a good idea, but I do think increasing the cooperation between the food and meat/poultry inspectors would be useful. I think again that the problem is not that the FDA does not understand its mission but that they are not funded adequately to do the functions they have been assigned.

    Calls for new agency
    Chemical & Engineering News: Government & Policy - Food Safety System
    ScienceDaily: Calls For A New Food Safety Regulatory Agency Follow Spinach Tragedy

    Here is a quote from the Chemical & Engineering News article that supports my position.

    According to Michael R. Taylor, an epidemiologist at the University of Maryland School of Medicine, the primary missing element is resources. FDA does not have the resources to do inspections and set up testing systems, nor does it have a mandate “to drive primary prevention at the point of production,” he says. Another problem, he says, is no one—not the head of CDC, FDA, or USDA or California officials—is in charge of preventing the next outbreak of E. coli in spinach or lettuce. When it comes to food, Taylor says, “all play a role, but no one is in charge, and no one fairly can be held accountable.”

    If food safety is an issue, then the FDA should be funded adequately in order to bring this expectation into reality.

    I would point out though that there other daily risks that are much more hazardous such as driving your car or even death from the flu. However, this does not mean that steps should not be taken to minimize the risks regarding foods.

    Other Resources

    E. coli infection, disease information, NCID, CDC

    Disease Listing, Escherichia coli O157:H7, Gen Info | CDC Bacterial, Mycotic Diseases

    The Cincinnati Post - Death by dining: excellent article

    US FDA/CFSAN - Nationwide E. Coli O157:H7 Outbreak: Questions and Answers (last updated Oct 20, 2006) only reall covers the spinach incident.
    CFSAN Video Library: Dr. X and the Quest for Food Safety (Real Media and Windows Media files)

    Recent Science Friday programs on food safety
    September 22, 2006, Hour Two: Tracking Food Safety / Solar Energy
    November 24, 2006, Hour One: Food

    Do our fears add up? - Town Online: good article on everyday risks.

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