Posted On: February 27, 2009

AstraZeneca Hid Bad Studies on Seroquel; Agrees to Increase Warnings

On Thursday, AstraZeneca, the manufacturer of Seroquel, a drug used to treat certain psychological conditions, agreed as part of court proceedings on the drug, to unseal and release certain documents to the public. Bloomberg News reports that these documents indicate AstraZeneca "buried" studies which were unfavorable about the drug. More than 15,000 people treated with Seroquel are suing the company claiming it withheld information regarding the relationship between Seroquel and diabetes from physicians and patients. There are also claims that Seroquel was promoted by AstraZeneca for uses that were not approved by the FDA. With regard to the suppression of these studies, one of AstraZeneca's management is quoted as saying in an email that "The larger issue is how we face the outside world when they begin to criticize us for suppressing data." seroquel.jpg


Bloomberg News further reports that one of the unsealed documents indicated that company officials felt one of the "buried" studies was a problem because it indicated weight gain while taking the drug. Gaining weight is known to be a factor in developing diabetes. The article goes on to discuss in detail several examples of AstraZeneca either hiding important study information from the FDA or working on how to "spin" information to avoid the negative implications. Where are the ethics? These are individuals bodies and health you are dealing with. Unfortunately, more indication that too many times its about the dollars and not about providing a safe and effective medication to the public.

At this same court proceeding, Bloomberg News also reports that lawyers for AstraZeneca indicated that it had agreed to strengthen the warning regarding Seroquel's relationship to diabetes by moving it into the warnings and precautions section of the label, indicating there is a stronger link between the drug and diabetes. The litigation regarding this drug is continuing and I expect there will be further reports regarding some of the "confidential" documents which are now being made public. I will be sure to update if there is anything of significant interest.

Posted On: February 24, 2009

Raptiva, Drug to treat Psoriasis, Linked to Rare Brain Infection

The FDA reported late last week that the psoriasis drug Raptiva may be linked to a rare, often fatal, brain infection known as progressive multifocal leukoencephalopathy, or PML. According to the FDA, it has received reports of 3 confirmed cases and one possible case of PML in patients being treated with Raptiva for moderate to severe plaque psoriasis. Two of these patients who were confirmed with PML have died and the the one possible PML also died. All of the patients had been taking the drug continuously for 3 years. There is no known treatment for PML.

In October of last year a black box warning (the most significant warning that can be given to a drug) was added addressing the risk of contracting certain life-threatening infections while taking Raptiva, including PML. The FDA indicates it is reviewing this latest information to determine if the risks of this drug outweigh its benefits. At the same time, the European Union's equivalent of the FDA, the European Medicines Agency (EMEA), has recommended that the drug be withdrawn from the European market. The EMEA has already determined that the risks of this drug outweigh its benefits. In Europe, the European Commission must approve the EMEA recommendations, but it typically does.

The FDA strongly recommends that doctors closely monitor their patients taking Raptiva, as well as those who have taken the drug in the past. Symptoms of the infection indicated by the FDA are weakness, blurred vision and difficulty speaking.

If you are presently taking this drug, or have in the past, you might want to consider contacting your treating physician and discussing this issue with him. I will say its curious that the EMEA immediately jumped on removing the drug from the market, while the FDA still needs to continue to look at this issue. There are other treatments on the market for psoriasis, so the delay by the FDA raises the issue again of the tail wagging the dog i.e. is Big Pharma again calling the shots.

Posted On: February 19, 2009

Recalls of the Week

Time for the Recalls of the Week. Other than peanut butter, not alot has been going on in this arena these past few weeks. That's a good thing actually. Anyway, although short and sweet, here's what we got:

1. Peanut Butter update:As you know I have previously posted about the peanut butter recall here and here. Companies throughout the country continue to recall products daily on the concern they may have had product from The Peanut Corporation of America (PCA). Make sure you review the FDA's site providing up to date information regarding products which have been recalled. PCA has now closed all its plants and a total of 9 people are reported to have died from salmonella related to its products. Last Friday, PCA filed for bankruptcy. It should be noted that national brands of jarred peanut butter have not been implicated in this recall. Both the New York Times and Washington Post wrote editorials last week addressing how this recall should be a loud call to the Obama administration that we need to do things to sure up our food supply. The FDA, due to its lack of money and size, cannot do it and we as Americans deserve a safe food supply. We cannot count on Corporate America to be good corporate citizens who will follow the rules of safe manufacturing and processing. We have seen too many times that left to its own devices, many companies will cut corners in an effort to maximize their profit at the cost of consumer safety. Now is the time!.

2. Evenflo Activity Centers: Evenflo is recalling over 200,000 Activity Centers which is a product made for infants and young children. When used as an activity table, cap on one end of the product can come off, posing a risk of falling for a young child. The recall includes Evenflo ExerSaucer Triple Fun stationary activity centers made between October 2006 through February 2009. If you have one of these, you should stop using it immediately and call Evenflo for a free replacement cap. For more information, see here.

3. True Value Wheelbarrows: True Value is recalling about 17,000 Green Thumb Twin Wheelbarrows it has sold in its stores from September 2008 through October 2008. Over-inflating of the tires could cause the wheel's plastic rim to break, posing risk of injury to the user. There have been two reports of the plastic rims breaking. If you have one of these, you should stop using it immediately and return it to any True Value store for a full refund. For more information, see here.

That's all we have for this week. Tune in next week for another installment of Recalls of the Week. If you have any questions or issues regarding a recalled product, please feel free to contact me.

Posted On: February 11, 2009

Recalls of the Week

Well the top of the recall news for several weeks now has been one thing...PEANUTS and PEANUT BUTTER. Everyday for weeks now I have received information indicating additional recall of consumer food products as a result of this absolute careless disregard for human life by the Peanut Corporation of America. I previously posted about the background regarding this recall, including a link to an up to date listing by the FDA of all food products pulled from the shelves as a result of this recall. To top things off, it is reported in today's Washington Post that a second peanut processing plant in Texas owned by this same company has been closed down after bacteria was found in products at that plant. To date, this salmonella outbreak has killed 8 people and sickened over 600 more in 44 states. The Texas state health officials (not the FDA) requested the Texas plant be shut down after lab tests indicated salmonella in roasted peanuts, peanut meal and granulated peanuts. I would expect many more recalls since the source has now been expanded. Even more interesting, until recently, government regulators, including FDA and the State of Texas, knew nothing about this plant in Texas because it had never been registered. As a result, this plant, which has been operating since 2005, has never been inspected by health officials until now. PH2009013003614.jpg


Consumer Reports indicates today that a ninth death has been linked to this recall. Moreover, the owner of the Peanut Corporation of America was suppose to testify before a congressional committee, but now is refusing to, as he is concerned of incriminating himself. The hearing, which took place without the owner's testimony, turned up information that the owner had urged his workers at the plant to ship products found to have salmonella, indicating he should be able to "turn the raw peanuts on the floor into money". The more we learn of this story, the more appalling and sickening it becomes.

This most recent investigation sheds clear light on the fact that the FDA is so understaffed and underfunded that it cannot properly protect our food supply. It appears that the only time they call into action is when the cat is out of the bag. Very rarely do they catch the problem before it has infected our food supply. Another significant problem to lay on the lap of our new administration. Now for a couple other significant recalls which have occurred over this past week:

1. KTM ATVs (All Terrain Vehicles): Yesterday KTM recalled approximately 2700 of its ATVs because the rear brake caliper support can crack, causing loss of pressure in front brakes, posing a risk of the rider losing braking and steering control. The model years involved are 2008 and 2009 and were sold at KTM dealers between August 2007 and January 2009. If you have one of these vehicle, you should stop using it immediately and schedule an appointment at the KTM dealer for a free repair. For more information, see here.

2. Safety 1st SmartLight Safety Gates: 100,000 Safety 1st SmartLight Stair Gates are being recalled because the hinges that hold the Stair Gate in place can break. If the Stair Gate is at the top of the stairs, a child could fall down the stairs. The model number at issue is 42111, which is printed on a sticker under the handle panel. The Gates were sold at Babies R Us and Wal-mart from January 2005-December 2007. If you have one of these gates, you should stop using it immediately and call the company to get a free repair kit. For more information on this recall, see here.

3. Jetboil Outdoor Stoves: Jetboil is recalling 15,000 Outdoor Stoves and Cooking Systems sold between July 2008 and November 2008. A valve attached to the fuel source can allow a gas link, posing a fire risk. Five reports of fires have been recieved to date. For a listing of the specific models involved, see here. If you have one of these stoves, stop using it immediately and contact Jetboil for a repair or replacement.

That's all the significant recalls I have for you this week. I will be sure to post any further significant updates regarding the Peanut Butter recall. As I suggested in my earlier post on this recall, for now, I would avoid using any products with peanuts in it until this issue is cleared up and the extent of this problem is fully understood. If you have any questions or thoughts on any of these recalls, contact me by either calling or emailing me through the contact form on this site. Until next time, be careful out there.

Posted On: February 1, 2009

Lawyers USA Touts Solo Practice University and What it Can Offer the Solo Attorney

Solo Practice University™Several weeks ago I posted about my selection as a faculty member of Solo Practice University to teach products liability. Earlier this week, Lawyers USA, a significant publication that address issues facing lawyers, reported on Solo Practice University and what it will offer to both those coming out of law school and those already practicing, but looking to venture out on their own. I was interviewed for this article and address what an innovative and exciting venture this is. The founder, Susan Cartier Liebel is a great inspiration and her excitement and passion for this project is infectious. For more information regarding Solo Practice University and what it will offer, as well as the amazing faculty that have already been announced, see here.