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The bogus academic credentials of Richard A. Gonzalez, the CEO-to-be of the Abbott spinoff, AbbVie, were "misstated" as far back as 1998.

In Abbott's announcement of executive promotions via PRNewsire, dated February 13, 1998, Gonzalez was promoted from vice president of Abbott HealthSystems division to senior vice president of the company's hospital products division. His background was provided:

"He has been with the company for 20 years, and also has held several management positions in the United States and Canada for the diagnostics division. Gonzalez holds a bachelor's degree in biochemistry from the University of Houston and a master's degree in biochemistry from the University of Miami."

In a January/February 2005 issue of Hispanic Business, however, Gonzalez's background is more vaguely (but still disingenuously) worded.

"Prior to joining Abbott, Mr. Gonzalez was a biochemist at the University of Miami School of Medicine."

(A more accurate description would have described him as a second semester sophomore, it appears.)

Then on April 2, 2006, the Chicago Tribune published a relatively flattering profile of Gonzalez, for which he curiously declined to be interviewed. Bruce Jaspen wrote, "Abbott's public affairs team said he has been immersed in meetings and focusing on his new responsibilities [overseeing Abbott's pharmaceutical business] and the additional business he oversees."

The writeup also stated that the "52-year-old Abbott veteran has survived a battle with throat cancer, and the company says he has been successfully treated." This statement implies that Gonzalez did not leave Abbott in 2007 "to battle throat cancer," as others have written (unless he had a recurrence of disease).

Gonzalez's erroneous academic background was also repeated by Jaspen. Gonzalez's education is listed as a "Bachelor's degree in biochemistry from the University of Houston and a master's degree in biochemistry from the University of Miami."

I'd find it astonishing that Gonzalez (even if he declined to be interviewed by Jaspen) did not read the 2006 profile of himself in the Tribune.

Meaning: Richard Gonzalez, longtime Abbott employee and prospective CEO of AbbVie (the Abbott drug spin-off), doesn't have a bachelor's or master's degree, as he claimed for years. The story was broken by Crain's Chicago Business and followed up by the Chicago Sun-Times. But it ain't no big thing, cluelessly offers an Abbott spokesperson, who ascribes the gaffe to an administrative error. The "administrative error" or lie, depending on your viewpoint, was included in SEC filings from 2002 to 2007. Mr. Gonzalez's Abbott bio (included among its "leaders") now states that he "was a research biochemist at the University of Miami School of Medicine and attended the University of Houston, majoring in biochemistry." So perhaps the highest executive of a new $18-billion company is a high school graduate.

HT: Pharmalot.

Image of perennial Abbott CEO Miles White (left) and prospective (and soon-to-be-ex) AbbVie CEO Richard Gonzalez (right) from Abbott's 2011 shareholder report.

Clarification: The issue is not whether someone without a college degree can successfully lead a company (we know the answer to that question), but whether someone who has (seemingly) lied about academic degrees can (or should). To me, the answer is obvious. Certainly such a person can't lead with any integrity.

10-03-12 update: Longtime Abbott CEO Miles White stands behind Gonzalez and claims that he and the company board knew of the CV error before selecting Gonzalez to lead AbbVie. White distributed a memo/letter to company employees earlier this week, which was posted by Pharmalot. An excerpt:

There was an error made when Rick's Company biography was originally written many years ago. It incorrectly stated that he had earned Bachelor's and Master's degrees. Rick brought this error to the Company's attention after his retirement and prior to returning to the company in 2009. We conducted an internal and external investigation of the matter and his biography was subsequently corrected. After full discussion the Board and I concluded he is the right person to lead AbbVie.

However, the memo (which implies that news stories on the subject have not been entirely factual) fails to state how the false degrees were originally incorporated into Gonzalez's biography and why the errors went uncorrected for years (by Gonzalez especially), until Gonzalez retired. The memo also fails to mention how or why Gonzalez finally recognized the errors during the time of his retirement (from 2007 to 2009).

Despite Abbott's claim of an "administrative error," this explanation seems unlikely (and frankly insulting) given that Gonzalez would have provided the original information about his educational background to Abbott's HR department.* Perhaps an administrator or a PR person might have innocently and incorrectly assumed that Gonzalez obtained a bachelor's degree from the University of Houston, after he stated that he had attended the school and majored in biochemistry there. But the same assumption does not apply to claiming a master's degree from the University of Miami. If Gonzalez told HR that he attended school there after the University of Houston, several big assumptions would have to be made by HR to (falsely) conclude 1) that Gonzalez attended graduate school, 2) that his concentration was biochemistry, and 3) that he obtained a master's degree (as opposed to a PhD). The only reasonable and logical conclusion is that Gonzalez supplied these false details himself. This conclusion is also consistent with the fact that the errors were not corrected for years.

According to Crain's, Gonzalez attended the University of Houston from the fall of 1972 to the fall of 1973. (It wasn't confirmed whether Gonzalez majored in biochemistry; although it is unlikely that Gonzalez would have gotten very far in such a science-heavy major after about 3 semesters of college. As far as I can remember, I couldn't enroll in biochemistry--as a college junior, iirc--until I had taken 2 terms of organic chemistry, which required the prerequisite of 2 terms of general chemistry.) Gonzalez attended the University of Miami for 1 semester, from January to May of 1974. It is unlikely that this course of study was at a graduate level, given that Gonzalez would have left the University of Houston as a college sophomore. The University of Miami would not or could not confirm Gonzalez's employment as a research biochemist, because it only confirms the status of current employees. And Gonzalez is evidently not available to the press to confirm these details or add information that can be later confirmed (such as, what U Miami lab he worked in).

The fact that Miles White fails to see a problem with any of this and, moreover, backed and continues to back Gonzalez as CEO of AbbVie speaks volumes about the integrity and values (or lack thereof) among the highest executives at Abbott. I don't know how any Abbott employee, who's slogged through and successfully completed their own professional education (particularly in medicine and the sciences), can look at those guys with anything but contempt and disgust.

* Although the HR department should be severely scolded for never doing something as "HR basic" as checking on on Gonzalez's credentials.

This morning, the FDA has finally stepped in and is warning healthcare professionals and MS patients alike about death and other injuries associated with the so-called "liberation procedure" (ugh), which amounts to either angioplasty or stenting of (typically) jugular veins. The procedure, which is ostensibly designed to promote the egress of blood flow from the brain, has no basis for use, because there is no confirmed link between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis. For background on this ever-vexing issue, start here.

The FDA has received reports of associated adverse events, which include "death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding." In February, the agency sent a letter to a NY vascular surgeon, warning of "objectionable conditions" and the lack of regulatory protocol and oversight for what amounts to an investigational (ie, non-FDA-approved) procedure.

There may be no good guys in the questionable chain of international drug wholesalers that recently peddled fake Avastin. Yesterday the WSJ reported that the 2 managing directors of the Danish wholesaler ran afoul of local law in 2007 by illegally importing medicines into Denmark. Although the paper, citing the Danish National Board of Health, was not able to convey the particulars—eg, what medicine from what country.

Previous news reports imply that it was either the Danish wholesaler or the Swedish outfit that notified US authorities of the counterfeit Avastin, which then passed through a British wholesaler, River East Supplies, Ltd., before reaching the United States. Canadian Thomas Haughton reportedly manages a network of drug distributors, including River East Supplies, Ltd, as well as the US supplier of the fake drug, Montana Healthcare Solutions, which Haughton acquired in 2010 through a Barbados holding company. The Avastin-that-was-not-Avastin was then distributed by a Tennessee-based distributor to 19 medical practices, most of which are in California or Texas. It is unclear whether any cancer patient actually received the fake IV drug, which contained salt and starch (among other inactive ingredients).

The origin of the fake Avastin is also unclear. Named suspects include China, Egypt, and Turkey.

The path of the fake Avastin that recently entered the United States is painfully complex and possibly a template for the terribly circuitous travel of questionable drugs throughout the globalized marketplace.

According to the latest coverage by the WSJ, the ersatz cancer drug—which possibly originated in China (where else, folks, where else?)—traveled through Turkey and Egypt before being sold by Swiss and/or Danish wholesalers to a UK-based wholesaler. From the UK, the phony vials were sold and imported into the US by a Canadian, Thomas Haughton, who lives in Barbados and manages a "network of drug distributors," including the UK wholesaler, River East Supplies, Ltd.

As well, Haughton owns or manages a Barbados-based holding company that acquired Montana Healthcare Solutions in 2010. Montana Healthcare Solutions, the reported contact for which is (or was) one Paul Bottomley in tiny Belgrade, sold the fake Avastin to 19 medical practices, most of which are in California. The drug was then shipped or distributed by the Tennessee-based Volunteer Distribution, the management of which is pretty damn sketchy.

The FDA is leading the necessarily complex federal investigation, but the US Attorney in Los Angeles is also issuing subpoenas to the California practices, writes the WSJ. The paper adds that Haughton had no idea that the Avastin was fake (despite the product's rock-bottom price). Furthermore Haughton "no longer does business with" the Tennessee distributor (although this end-of-the-line company, whatever it is, may be a mere scapegoat for the much-more globally connected Haughton).

Here's hoping that news sources like the WSJ stay on top of this developing story.

The most recent lots of counterfeit Avastin (Roche), which found their way to various oncology clinics in the United States (most of which are in California), originated in Egypt and were essentially a slurry of inactive ingredients, reports Fox News. The fake vials of the purported anticancer drug contained a hodgepodge of salt, starch, citrate, isopropyl alcohol, "propandiol" (probably propylene glycol), t-butanol, benzoic acid, difluroinated benzene, acetone, and phthalate—but no bevacizumab, the monoclonal antibody and active ingredient in Avastin that is intended to suppress angiogenesis and tumor growth.

The counterfeit vials were reportedly processed through legitimate distributors in Switzerland, Denmark, and Britain before entering the United States, where the fake drug was sold to 19 oncology clinics or physicians by Quality Specialty Products (aka Montana Health Care Solutions). A company with the terribly generic name of Volunteer Distribution,* located in Gainesboro, Tennessee distributed QSP's products, according to the FDA.

A web search reveals an address for Volunteer Distribution in Gainesboro: 101 W. Gore Ave. Google Maps provides this lovely screenshot for the Tennessee address, although the location is identified on the annotated street view as "Anderson & Haile Drug Co Phrm." A web search also reveals the listed phone number for Volunteer Distribution as 931-268-4506; that for Anderson & Haile is 931-268-0233.** Important update: Further searching of Google Maps and its street-view feature shows that Anderson & Haile is actually located in a commercial property at the corner of W. Gore Ave. and S. Union St. in Gainesboro, Tennessee.

Fake Avastin (or Lucentis) on the market is evidently an ongoing problem for Roche (and susceptible patients). Shanghai was the source for a bogus version in 2010, and Syria in 2009, says Fierce Pharma.

What vials of Avastin should contain are bevacizumab (the active ingredient), along with trehalose dihydrate, sodium phosphate (both monobasic monohydrate and dibasic), polysorbate 20, and water.

* I suppose that "Volunteer" must refer to Tennessee.

** And another web search provides these listed contacts for Anderson & Haile at 101 W. Gore Ave: Teneal Jenkins and Christie Banker. Yet another web search shows that Teneal Jenkins is "doing business as" Anderson and Haile Drug Company, a pharmacy and supplier of medical equipment and supplies. And yet another web search shows that Teneal Jenkins has a PharmD. A license lookup at the Tennessee Department of Health shows that Teneal Chaffin Jenkins of 101 W. Gore Ave in Gainesboro, Tennessee (Anderson and Haile Drug Co.) graduated with a PharmD in 2004 from the University of Tennessee (Memphis) and has sustained no disciplinary or significant liability claims.

And a clarification: I have no idea if Anderson & Haile Drug Company, located at 101 W. Gore Ave., in Gainesboro, TN, or pharmacist Teneal Jenkins and Volunteer Distribution, located at the same commercial building, have (or had) any connection whatsoever. Although it would be an unfortunate coincidence for Anderson & Haile and pharmacist Jenkins if they did not. FWIW, street images of the area, courtesy of Google Maps, show unreadable hanging shingles and ascending stairs to an entrance at the back of the building.

And reasonably, I might add. Here's the video link. Notably the piece was done with the cooperation from higher-ups at Duke Med (ie, Robert Califf).

Potti is now an oncologist at South Carolina's The Coastal Cancer Center, the website for which advertises Potti's time at Duke University and (not surprisingly) makes no mention his colossal scientific fraud while there.

Sherley et al v Sebelius et al. The case that won't go away...to the chagrin of scientists who rely on government funding for research with human embryonic stem cells (hESCs).

The Nature News Blog reports today that scientists James Sherley and Theresa Deisher, who choose to work with adult stem cells, are appealing Judge Royce Lamberth's reluctant decision in July to shoot down a permanent injunction against federal funding for hESC research. The scientists submitted their legal brief yesterday to the US Court of Appeals for the DC Circuit. The appeals court, which ruled against Sherley et al last April (with respect to their request for a preliminary injunction), will hear oral arguments on April 23rd in this new appeal to overturn Lamberth's ruling against a permanent injunction.

But a similar decision granting federal funds for hESC research by the appeals court is not a given. The randomly selected, 3-judge panel for the April hearing will be somewhat different than the one that ruled last year, the Nature News Blog reveals. The judges for the upcoming appeals hearing will be Republican appointees Chief Judge David Sentelle, Judge Janice Rogers Brown, and Judge Karen LeCraft Henderson. The lone, common panel member is Henderson, who dissented in the previous appeals hearing by calling the government's favorable interpretation of existing law (ie, the highly ambiguous Dickey-Wicker amendment) "linguistic jujitsu."

Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html. 

About one-third of cognitively normal elderly demonstrate an elevated load of beta-amyloid,* a pathologic hallmark of Alzheimer disease, in the brain, according to a newly published study from the Mayo Clinic. These data support previous observations, in which the PET-imaged brains of about a third of elderly, nondemented subjects will exhibit an abnormal accumulation of the AD-associated protein.

However, the Mayo investigators went a bit further by examining the potential association between the load of beta-amyloid, as measured with an established radiolabeled tracer (Pittsburgh compound B, or PiB) on PET images, and cognitive performance on various memory, language, attention, and visuospatial tests. As well, a relationship among brain amyloid, cognitive performance, and APOEe4 status (a well-known genetic marker for AD) was examined. What the researchers found was that poorer cognitive performance was associated with greater amyloid deposition, and that this relationship was more robust in APOEe4 carriers. Conversely the association between amyloid load and relative cognitive impairment was much weaker (ie, only "modest") in subjects who did not carry an APOEe4 allele, suggesting (the authors concluded) "that APOE isoforms modulate the harmful effects of [beta-amyloid] on cognitive function."

What any of this information means practically is very murky, however. Will some of these cognitively normal subjects with heavier amyloid burdens (and who perform less well on cognitive tests) develop AD—that is, if they live long enough? Is AD more likely in these subjects if they're APOE e4 carriers? We don't know, and obviously further longitudinal work is necessary. The Mayo authors do imply that follow-up is ongoing.

In an accompanying editorial, Buchman and Bennett commended the Mayo investigators for the size of the study (a highly respectable 408 subjects [with a median age of about 80 years]) and their "important contribution to our understanding of AD, illustrating that even among persons without dementia or [mild cognitive impairment], amyloid deposition is associated with very mild symptoms, especially among carriers of the APOE e4 allele." But "[w]hether...amyloid imaging agents will have clinical utility remains to be determined," the editorialists appropriately caution. They advise about the lack of data concerning the prognostic value of amyloid retention (presumably in any subjects, whether demented or not) and how amyloid retention may change over time. And they add that the utility of amyloid-imaging agents "will remain low in the absence of an effective amyloid modulating agent." In other words, what's the point of knowing the amyloid burden if you can't do anything to lighten the load?

A related issue, however, not explored by the editorial authors, is whether even removing amyloid in the context of cognitive impairment, is beneficial or, in fact, does more harm. Existing AD trials suggest that amyloid-modulating agents (eg, bapineuzumab) can cause brain edema—presumably due to the removal of vascular amyloid—and that they do so without improving cognition to any substantial degree overall.

Intervening earlier with anti-amyloid drugs in less cognitively impaired subjects, as proposed by some industry investigators, is a tricky move: obviously primum non nocere in persons with only mild cognitive impairment and certainly in individuals with no practical cognitive problems (regardless of their amyloid burden).

PET = positron emission tomography.

* Defined by a "global cortical PiB retention ratio" of greater than 1.50.

Photograph: Atrophied brain from person with AD from National Institute on Alcohol Abuse and Alcoholism.

For those who are following the XMRV-CFS-Mikovits story, science blogger John Timmer at ars technica provides a decent synopsis of the crazy soap opera/Greek tragedy.

Specifically Timmer outlines a complicated narrative in reasonably comprehensible (but not outstanding*) prose. The salient points:

• the rise and fall of data linking XMRV with the dubious CFS;
• researcher Judy Mikovits's refusal to abandon the idea that XMRV is associated with CFS, despite others' data indicating XMRV contamination;
• the symbiotic nexus between Mikovits and individuals with CFS, some of whom reportedly tried to undermine any investigation debunking the link between XMRV with CFS;
• Mikovits's subsequent unethical, and possibly criminal, behavior; and
• the overall integrity of the collective, collaborative scientific process (including nods to the DHHS and the "publishing system").

* One feels that Timmer's lengthy post could be a terrific short article with some professional editorial help.
CFS = chronic fatigue syndrome; DHHS = Department of Health and Human Services; XMRV = xenotropic murine leukemia virus-related virus.