Sunday, July 31, 2011

Charred shrink wrap in Merck vaccines/ WSJ

Extraneous materials in vaccines is an old story.  Many have been shown to contain unwanted viruses or even bacteria such as mycoplasma.  (I used to have the abstracts posted on my website showing examples.)  Anthrax vaccines had flecks of stopper material and fungi in them, noted on visual inspections by FDA in the late 1990s.  Today Merck's West Point, PA plant has been cited for problems.  From the WSJ blogs and WSJ:
When you make drugs or other medical products, unwanted contaminants can fall into the mix — say, beetle parts (in baby formula) or glass flakes (in anemia drugs).
The latest pharma world example of wow-that-really-shouldn’t-be-in-there comes from Merck. As the WSJ reports, the company says charred bits of plastic shrink wrap have been found in vials of vaccines made at a big plant in West Point, Pa.
Affected products include Gardasil, used against the human papillomavirus, as well as shots against shingles, measles/mumps rubella, pneumococcal disease and chicken pox.
How’d this happen? It seems pieces of the wrap weren’t removed during vial washing and were charred during a sterilization process. Merck says there are no reports of adverse health problems, though theoretically the particles could cause a reaction at the injection site. The problem is very rare, according to the company.
The FDA has been tracking problems at the plant since 2008, according to the WSJ. A series of inspection reports have chronicled the issues — most of which have been resolved, Merck says. Here they are:

An April 2011 report cited the shrink-wrap particles, saying there were a dozen company-submitted reports about the problem since November, 2009 — eight due to customer complaints. The report noted that while plastic boxes replaced shrink-wrapped vials in some cases, some product vials were still being shipped in the wrap, raising the possibility of further problems. (Merck tells the WSJ it will end the use of shrink wrap on incoming vials by the end of the year.)

A report from August, 2010, found that an undisclosed number of adverse event reports involving drugs made at the plant weren’t submitted to the FDA in a timely fashion — that is, within 15 days.

An inspection report from January and February of 2009 identified problems including stainless steel particles in certain vaccines and a treatment for black widow spider bites, and cracked vaccine vials.

1 comment:

Anonymous said...

The more things change, the more they stay the same.

August 20, 2011 9:35 AM

Shortage of key hospital drugs a "major crisis"
The Food and Drug Administration says hospitals are running out of many important drugs, including popular chemotherapy medications such as Doxil.

That, officials say, has created a huge gray market in which some medications are marked up more than 600 percent.

On "The Early Show on Saturday Morning," CBS News Medical Correspondent Dr. Jennifer Ashton told co-anchor Rebecca Jarvis, "This is a major crisis ... and we will be hearing more about it.

"Usually, when you talk about shortages, it's either one of two things, or both, supply or demand. In this case, it really seems to be an issue with supply.

"The majority of these drug shortages really arise from one of a couple of possible reasons. One of them is low capacity with the manufacturing process. A lot of these companies, a lot of these drugs are made in companies or factories that just don't have the capacity to make more. A large percentage of these problems come when the inspectors, either the companies or the governments inspecting the production process, find contamination in these medications. They are more complicated to make. A lot of them come from ingredients we have to import from other countries, and contamination is a problem. And some of them are generic, (and have a) very low profit margin, and there is no financial incentive for some of these companies to keep manufacturing these drugs, because now they are so inexpensive."

Crucial cancer drugs in critical short supply

Ashton added, "We're talking about a lot of types of medications, anything from chemotherapy to drugs we use in the Intensive Care Unit for critically ill patients, in some cases steroids, antibiotics. We're not talking, for the most part, about drugs you would fill in your pharmacy, we're talking about drugs used in hospital settings for the sickest patients."

But, she points out, there are "a couple of things patients may be able to do, especially if they're in an elective situation. Number one is to call ahead to your doctor or hospital and find out if the drug that you're supposed to get, or the sequence of drugs, is in fact available. Secondly, you always want to ask your doctor if there are options or alternatives. Sometimes there are, sometimes there are not. And lastly, if you're going in for an elective treatment and there is a supply problem, ask if you have some latitude about whether that treatment can be rescheduled. Again, in some emergency settings, ICU settings, there are no options, but if you're talking about an elective therapy, oftentimes that treatment can be rescheduled. It might not be ideal but it's a possibility."

Is the gray market a viable option?

"We try to discourage people from doing that," Ashton says, "because you don't know if the medication is counterfeit. You don't know if it's contaminated or has been handled or stored improperly.

"In large measure, those types of gray market dealings are probably legal, (but) they're also probably sleazy, and they may be dangerous.

"As long as the person selling the medication to this middleman can attest to the fact that those drugs have been purchased properly, it is legal.

"We're probably going to be seeing more and more of this. This is an emerging crisis. (It is a) big problem. The FDA and Congress are looking at it."

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