Fake Avastin Causing Major Uproar in National Media

Fake Avastin Causing Major Uproar in National Media

February 20th, 2012 // 3:41 pm @

Source: Pharmalot

For the past couple of days, the controversy over counterfeit Avastin – the cancer med sold by Roche and its Genentech unit – has made national headlines and renewed fears about phony meds making their way through the supply chain. The timing could not be worse, coming just as the crisis over assorted prescription drugs reaches a fever pitch.

In discussing the Avastin episode, the FDA noted there are only four approved suppliers and the outfit that purportedly peddled counterfeit version was not on the list – Quality Specialty Products, which the agency described as a foreign supplier that may also be known as Montana Health Care Solutions. Meanwhile, Volunteer Distribution in Gainesboro, Tennessee, distributes QSP products (read here). Paul Bottomley, the business development director at Montana, did not answer a phone number listed on a Montana pricing sheet.

So far, the FDA has publicly identified 19 medical practices that potentially purchased the counterfeit med (here is the list). All but two are located in California. We have reached out and, so far, only two have responded. We received this statement from the office Mohamed Grhaowi of the South Texas Comprehensive Cancer Centers:

“We have been asked to assist the FDA in its investigation and we have conducted a preliminary investigation of our records concerning this matter. We are continuing our investigation into this situation and we are communicating with all of our pharmaceutical suppliers to insure and verify the integrity of their supply chains and of the medications that South Texas Comprehensive Cancer Centers and Dr. Ghraowi receive from those suppliers.”

And The Beverly Hills Cancer Center says the practice “is in the process of determining from its records whether it purchased any Avastin from Montana Healthcare Solutions that was part of the lot numbers recently identified by the FDA as possibly being counterfeit. The center also had no idea that MHS was a foreign supplier. In fact, the center believes that MHS is a licensed distributor of pharmaceuticals located in the State of Montana.

“At the time, the Center purchased drugs from MHS, we believed that the drugs were legal and approved and only recently learned from the FDA that some of the drugs may have been counterfeit or unapproved… To date, the center has identified no adverse effects for any of its patients who may have received drugs purchased from MHS.”

Meanwhile, the FDA has noted that phony Avastin could have been spotted. For instance, the counterfeit med says Roche on the packaging and writing on the box is in French, instead of English. And in the US, Genentech is the distributor, while Roche distributes Avastin outside the US, and the version approved in the US does not sport the Roche logo on the packaging or vials.

These may be more noticeable than other distinctions, such as differences in the coding for batch numbers and dates. And a source at one physician practice, who asked not to be named because an investigation is ongoing, insisted that none of the Avastin that was purchased in recent months sported French anywhere on the packaging.

avastin-pricing-montana-sheetNonetheless, this raises some questions about the purchasing process. Presumably, a lower cost may have prompted an office to buy the counterfeit version. A list of various meds sold by Montana Healthcare Solutions and priced a Avastin 400 mg vials for almost $2,000, compared with the nearly $2,400 that Genentech charges in the US, according to a pricing sheet (here it is).

It is not yet publicly known how much was paid for the phony Avastin, but a 17 percent discount is significant. Is it unreasonable to ask why those offices did not question the ability of a distributor to offer a much lower price? Or to wonder if there was something different about the supply that allowed for such a discount? Or was it a case of ‘buy now and ask questions later?’

Perhaps no one thought to ask. A good is a good deal. And hindsight, of course, is hindsight. And it may be easy now to say there were obvious distinctions in packaging, but one could also argue most differences between the kosher and the phony Avastin boxes and labeling were not that obvious, even to someone who checks a shipment, regularly places meds on a shelf or reaches for a vial.

Just the same, the chain of events is a cautionary tale that reminds us of an old adage – if something seems too good to be true, it must be. Unfortunately, at least some physician practices failed to keep this in mind and, presumably, felt they simply had gotten a good deal. Meanwhile, the FDA investigation is ongoing and some practices will likely wish they scrutinized purchases more closely.

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