Merck is Caught Dumping Chemicals in Pennsylvania

Merck is having a really bad week.

Today a settlement was announced with Merck with the EPA and the Pennsylvania Department of Environmental Protection. Merck was caught dumping potassium thiocyanate (KSCN) which reacted with the water supply and caused extensive fish kills in the Wissahickon Creek in June and caused them to stop their drinking water intake for several days and any recreational use of the creek. They also got caught dumping spent substrate and cleaning agents in August.

Merck will be paying out 1,575,000 in penalties and $10 million to put into place systems that will prevent future dangerous discharges at their facility. They will also be spending approximately $9 million for extensive environmental projects.

Article HERE

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And the plot thickens… Merck’s MMR II recalled in Canada

So, I’m pretty sure most of us haven’t heard about this recall yet.

On December 12th, Alberta Canada recalled the MMR II vaccine which was distributed in Alberta after 5 patients had anaphylactic reactions to the vaccine during a vaccination campaign. All of the patients were adult, had an allergy history and have fully recovered. Clearly, however, something is amiss. Merck Frosst Canada is currently soliciting reports of any adverse reactions elsewhere.

The five cases of illness came from lot 1529U which was distributed in Alberta and has been recalled. They have also recalled two other lots which were made from the same materials: 1528U and 1680U.

And yet through it all comes the very commonly heard phrase told to parents “there is no need to worry…”

Here are some articles that address the topic:

http://www.pharmalot.com/2007/12/merck-recalls-1-million-doses-of-hib-vaccine/

http://www.canada.com/montrealgazette/news/story.html?id=479a7b73-a93c-4505-8c15-3160b3773b80

http://www.canada.com/montrealgazette/news/story.html?id=dd3bb1a6-60ac-4f6f-a4fa-262c917c438e&k=682

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Vaccine Recall

Did anyone catch this very underplayed announcement?

Merck has recalled 1.2 million doses of the Hib vaccine, specifically PedvaxHib and Comvax. The recall was issued because, according to Merck, “The company cannot assure sterility for these specific vaccine lots.” According to their Q&A in regards to the recall they have this to say:

“The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low. However, because they cannot guarantee the sterility of these specific lots of vaccine, Merck is conducting this recall.”

Uh huh. Sure. Also interesting to note. Neither Merck or the FDA are big on advertising this recall on their main pages. There is absolutely no announcement or link to a recall announcement on their front pages. Why?

Take Merck for example. Even when you click on “Patients and Caregivers” there is nothing mentioned. Nor is it mentioned if you follow the “Product News” section in the bottom middle of their homepage. And if you type in the keyword “recall” in their search function it returns nothing in regards to the current recall. The only place you’ll find this hidden gem on their website is by clicking on the header “Newsroom” under “Press Releases”. For a company whose motto is “Where patients come first,” they sure seem to be challenged in communicating important safety information to their patients.

As far as the Food and Drug Administrations website goes the only way I could find info on the recall was to type in “merck recall” into the search function. I found no info on their Homepage, under Hot Topics, under Recalls & Alerts, under Press Releases, or under Drug Safety. The keyword search of recall also does not return the Merck Recall (at least not on the first page, I didn’t feel like searching through all 10 pages). Nope. To find information on this recall from the FDA or Merck you basically all ready need to know it exists.

Thank you Nikki for pointing out to me that I didn’t even find the current recall from the FDA site. The link I found by searching “Merck Recall” was from a recall back in 2001. She finally found the correct recall by searching under “Comvax Recall.” Astounding. I find it hard to believe that the FDA couldn’t find a simpler way to communicate this recall.

Here are the links to where I finally found the announcement of this recall on both sites:

FDA: http://www.fda.gov/cber/recalls/merhav121001.htm

http://www.fda.gov/cber/recalls/merckhib121107.htm – thank you Nikki!

Merck: http://www.merck.com/newsroom/press_releases/product/2007_1212.html

By the way, I took screen-shots of these websites to illustrate my point but I can’t figure out how to get the screen-shots into wordpress. It doesn’t allow me to paste and I can’t figure out how to save the screen-shots as an image that I could upload. If anyone knows how to do this, please let me know.

And why no screen-time on the news? Why did Brittney Spears and Stacy Peterson and every other news story that doesn’t affect the average American take precedence over this recall alert? Because pharmaceutical companies have their hands in many arenas of life that many of us don’t recognize or don’t want to believe.

So help spread the word. Because you can believe this would be the top news story airing around the nation if this vaccine had been manufactured in say, China…

Editing to add:

There also seems to be a lack of online news coverage of this recall as well. I’m hoping everyone will air this story more starting tomorrow 12/13. For now, here are the top results from google on “Merck Recall”. Notice the almost complete lack of real information on this recall. When you search “Merck Recall” most of the results belong to other recalls that have occured in the past.

Reuters, the number 1 result, dedicated a whole 3 sentences to the recall: http://www.reuters.com/article/governmentFilingsNews/idUSWBT00804820071212

Huliq.com: http://www.huliq.com/44645/hib-vaccine-recall-merck-due-contamination

Emaxhealth: http://www.emaxhealth.com/90/19013.html

MSNBC: http://www.msnbc.msn.com/id/22224884/

Additionaly, when I searched under “Vaccine Recall” the top result was still Reuters outstanding 3 sentence coverage. Also pulled up were:

About.com: http://pediatrics.about.com/b/2007/12/12/hib-vaccine-recall.htm

Winknews.com: http://www.winknews.com/news/local/12448056.html

The search also returned the Huliq, emaxhealth and TADA…

**the FDA recall (which was the last result on page 1 – interesting)

Thanks to Amercianmum for your viewing pleasure I give you the following screen shots taken just after midnight on 12/13/2007.

 

**Merck’s Home Page**

Nothing in regards to recall

**Merck’s Patients & Caregivers Page**

Still no info about recall…

**Merck Product News**

Nope, nothing here…

**Merck Newsroom**

Finally!! Something about the recall

 

Here are the FDA screen-shots. There is no excuse.

 

**The FDA Homepage Top Screen**

Nothing at all in regards to Merck Recall

 

**FDA Homepage Bottom Page**

Nothing here either…

**FDA Link to Press Releases**

Nothing here…

 

**FDA Recalls Top of Page**

Wouldn’t it make sense for it to be here? It’s not…

**FDA Recalls Middle Page**

It wasn’t further down the screen either, look at the dates

Here is the first FDA Search. Searched “Recall”

Nothing here…

***FDA Search “Recalls”

How about if I add an “S”? …. Nope, still nothing

***FDA Search: Merck Recall”

This should definitely pull it up. Nope, the old recall of 2001

FDA Search “Comvax Recall”

Tada there it is…

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Merck Vaccine Recall Q&A

The following Q&A in response to the Merck Recall Vaccine was obtained from the following article. Amazingly enough (or not) I could not easily find this information on Merck’s own website. See my other post for more info.

What vaccine is being recalled?

Merck & Co. has initiated a voluntary recall in the United States for ten lots of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and two lots of COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]. The affected doses were distributed in the U.S. starting in April 2007.

The lots that are being recalled are:

Product Description – Lot # – Expiration Date

PedvaxHIB® 0677U 11 January 2010
PedvaxHIB® 0820U 12 January 2010
PedvaxHIB® 0995U 16 January 2010
PedvaxHIB® 1164U 18 January 2010
PedvaxHIB® 0259U 17 October 2009
PedvaxHIB® 0435U 18 October 2009
PedvaxHIB® 0436U 19 October 2009
PedvaxHIB® 0437U 19 October 2009
PedvaxHIB® 0819U 09 January 2010
PedvaxHIB® 1167U 10 January 2010
COMVAX® 0376U 05 January 2010
COMVAX® 0377U 08 January 2010

No other lots of PedvaxHIB® or COMVAX® and no other Merck products are affected by this recall.

Why are these lots being recalled?

Merck is taking this step as a precautionary measure. The company cannot assure sterility for these specific vaccine lots. The potential contamination in these specific lots was identified as part of Merck’s standard evaluation of their manufacturing processes. In routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB® and COMVAX®, Merck identified the presence of a certain bacteria called Bacillus cereus. Sterility tests of the vaccine lots themselves have not found any contamination.

The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low. However, because they cannot guarantee the sterility of these specific lots of vaccine, Merck is conducting this recall.

What is the extent of the recall?

About 1 million doses of vaccine are being recalled, including ten lots of PedvaxHIB® and two lots of COMVAX® that were distributed in the U.S. as well as vaccine lots within the CDC stockpile.

Will children who received vaccine from affected lots need to be revaccinated?

No. Children who received Hib vaccine from affected lots do not need to be revaccinated. No potency concerns have been identified for these vaccine lots.

What are the risks to children who received vaccine from affected lots?

Sterility tests of the vaccine lots themselves have not found any contamination. Merck has not received any reports of abscesses or disseminated B. cereus infection in children who received vaccines from affected lots. In addition, no problems have been detected by the Vaccine Adverse Event Reporting System (VAERS) related to the Hib vaccine affected by this recall. However, since sterility of the vaccine cannot be assured, if a child was vaccinated with a vial of PedvaxHIB® or COMVAX® that contained B. cereus or other microorganisms, there may be a risk of developing localized or disseminated infections. Immunocompromised children may be at the greater risk for these infections. These infections are most likely to occur within one week after vaccination.

VAERS will continue to monitor adverse events following vaccination as they are reported. Any potentially vaccine-related adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (or at www.vaers.hhs.gov (exit)), and to Merck at 1-800-672-6372.

What should providers do if they have recalled lots in their office?

Providers should immediately discontinue use of any of the affected lots and follow Merck’s instructions for returning recalled vaccine (both VFC and non-VFC vaccine).

How does this impact the nation’s Hib vaccine supply? Are there other Hib vaccine manufacturers?

As a result of this recall, providers who only use Merck Hib vaccines may have none, some or all of their vaccine recalled, and about half of the Hib vaccine in CDC’s stockpile is being recalled. CDC realizes that some providers will be faced with the prospect of having children to vaccinate with no vaccine available. There are two U.S. Hib vaccine manufacturers – Merck & Co., Inc. and sanofi pasteur. In the past, each manufacturer has produced about half of the nation’s Hib vaccine supply.

What is CDC doing in response to the shortage of Hib vaccine?

CDC is in contact with the two U.S. Hib vaccine manufacturers – Merck and sanofi pasteur. CDC is assessing availability of Hib vaccine and timing of future supply, and will make appropriate recommendations soon. Key considerations being addressed by CDC, along with partners such as the American Academy of Pediatrics, the American Academy of Family Physicians, and a representative of CDC’s Advisory Committee on Immunization Practices, include whether to change recommendations for Hib vaccine temporarily and how to allocate the smaller CDC stockpile of Merck’s Hib vaccines.

Will the shortage of Hib vaccine result in an increase in disease occurrence of Haemophilus influenza type b?

Fortunately, current immunization rates in the U.S. for Hib vaccine are high. In 2006, about 94% of U.S. children 19-35 months of age were vaccinated against Hib. This has resulted in a dramatic decline in transmission of this bacteria; however, it has not gone away completely. Experience has shown that we cannot let down our guard against vaccine-preventable diseases such as Hib. When immunization rates fall we are susceptible to increases in disease occurrence, so we are taking the current situation very seriously.

What should providers tell their patients?

For the time being, providers should continue to use Hib vaccine not affected by this recall according to current ACIP recommendations. If concerned parents contact their providers, they should be informed that children who were vaccinated with vaccine affected by this recall do not need to be revaccinated. Although there have been no reports of any adverse reactions among children who have been vaccinated, parents of children recently vaccinated with recalled vaccine should watch for any signs of infection (such as redness and swelling at the injection site) and contact their providers if such reactions occur. It should be emphasized that sterility tests of samples from the recalled lots have not found any contamination and the potential of contamination of any individual dose of Hib vaccine is very low.

What should providers do if they have no vaccine or little vaccine in their office?

Providers with shortages of vaccine may defer the booster (12-15 month-old) dose of Hib-containing vaccine in fully immunized children who are not otherwise at increased risk of invasive Hib disease (see question 13). Providers who are completely out of Hib vaccine, can contact sanofi pasteur regarding the availability of Hib vaccine to meet immediate short term needs.

What should providers do if they have no or little vaccine in their office and they are a VFC provider?

VFC providers should contact their health department. CDC anticipates additional guidance will be available soon.

Are some children at high risk for Hib?

Yes. Children at increased risk for Hib include: children with sickle cell disease, leukemia and malignant neoplasms, HIV and certain other immunocompromising conditions, asplenia, as well as American Indian and Alaska Native children. Vaccinating these children according to the recommended schedule is a high priority.

Note: Merck has a National Service Center that can answer questions about medical and other issues related to this recall, 1-800-672-6372.

Visit our previous news story to read more about Merck’s Hib vaccine recall and Merck’s news release on the recall.

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