This year’s list has attracted criticism for its inclusion of controversial characters such as Paul Ruddock — whose hedge fund management company Landsdowne Associates made £100 million ($156 million) betting on the collapse of Northern Rock — and Gerald Ronson, who was sent to jail for six months and fined £5 million in 1990 for his part in the Guinness share-trading scandal (but has since redeemed himself with much philanthropic fundraising). There was also a measure of hostile reaction to the knighting of Paul Bazalgette, a TV executive responsible for bringing the egregious Big Brother to British TV screens.

Still, none of this is bad for pharma’s reputation — in such company Witty really does seem something of the ‘knight in shining armour’, rewarded as he is for services to the economy rather than donating vast amounts to the Conservative Party (which some would suggest is the reason for Ruddock’s recognition). And Witty is not the only pharma industry representative to be honored. Richard Barker, former Director-General of the Association of the British Pharmaceutical Industry, was also handed an OBE (Order of the British Empire).

This announcement came just a couple of weeks after Witty — in his capacity as President of EFPIA — outlined the industry’s “significant concern” to EC Health Commissioner John Dalli over the debt crisis in Europe, particularly in Greece, Italy, Ireland, Portugal and Spain, where, he pointed out, pharma has been obliged to take price cuts and discounts of more than €7 billion ($9.3 billion) during 2010 and 2011. “The pressures on innovation are now immense,” Witty wrote. “I believe it is time to review current pricing and reimbursement practices…” Last month The Telegraph reported that the European price-cut toll has seen GSK’s revenue fall by 4% in the region during the third quarter. Witty predicted that the ongoing crisis (along with the effects of US healthcare reform) will cost GSK about £325m ($507 million) this year.

GSK’s lifeline, of course, is now coming from the emerging markets — outside America and Europe, the company’s Q3 sales grew by 17% — which now represents 38% of its total turnover. But with pharma particularly vulnerable to issues of trust and pricing, Witty’s stance suggests that standing firm and stoically weathering the blows is no longer going to be enough to ride out Europe’s economic storm.

If there is one message that big pharma has applied consistently over the years, it is that drug development is very expensive. Big bucks and long-term investment in the institutional know-how and capacity built exclusively through private enterprise are what count in delivering new therapies to patients.  But like everything else in a dog-eared play book written in what might as well be the technological equivalent of the quill pen, that consensus is now being “goosed” — and from within the industry’s own ranks at that.

In a September 27 speech to the Indian pharma association that attracted little notice here in the US, GSK CEO Andrew Witty plucked some of the substance out of that linear defensive policy wall built by the industry over the past two decades, namely, that the high risk of compound failure leads inevitably to high costs and that this in turn justifies big margins on new launch therapies, across the board.  In his remarks, Witty literally turned the argument on its head, declaring that the industry-backed estimate of more than a billion dollars on average to bring a compound forward from discovery to market authorization was “unacceptable.”  The only “evidence”  it provides is for the perpetuation of a 25 year old model of commercialization, one that frames the debate around larger issues of pricing, IP  and access in a manner that serves the interest of neither the patient, society — or the industry.

What Witty was alluding too is the folly of a message that relates high costs and high prices to what is in essence the burden of low R&D productivity — and the honest way to call that is an “industry failure,”  which he did in his talk.  “We need to fail less, and deliver more,” he said, and directly linked success in restructuring the R&D enterprise to lower development costs in making the best new innovations more affordable, at all income levels, within and across markets.

As usual, Witty raises important and provocative issues that all stakeholders in health ought to take into account.  Just one that comes to mind:  If high prices that lower access are attributable to a flawed R&D development model, is there a readily applicable formula that industry can embrace in delivering better results at lower costs?

From an industry-wide perspective, Witty has accentuated the need for a consensus to promote those “lean management” business tools that can boost productivity and dramatically lower the cost of failure.  Yet to date almost all the evidence accumulated and backed by industry focuses on the inevitability of escalating commitments, whether it be the opportunity cost of sinking scarce funds into early discovery ventures, or the inability to predict with any certainty the response of payers to pricing post-launch.  Overall, the numbers paint a scenario of gloom:  a survey released by the consultant group KPMG last month finds that ROI from in-house investment in R&D among the 30 top drug makers is today half of what it was in 1990.

And while pressure for more affordable pricing is gaining momentum everywhere, due to a demographic and income transition in many emerging markets and the fiscal meltdown in mature countries, new costing commitments placed on the industry are rising too.  How many CEOs are really aware of the multi-million dollar price tag for post-marketing safety studies required by regulators over a time period that often extends beyond the life of the product’s patent?  Funding the demand for post marketing information about how well innovations work in practice is beginning to exceed what is spent to obtain a license to sell in the first place.   Or the endless, “write another check” implications of expanded access programs for yet to be approved drugs, where for ethical reasons there is no end point for giving drugs for free to patients with no other treatment options.

Hard data drives policy — it makes industry positioning credible.  Fresh arguments with verifiable metrics to show the industry actually has a strategy to make its own technology cheaper — and thus suitable for a global market of radically diverse price points — will be vital to the repositioning that Witty seeks.   In other words, the challenge is that while the problem is now defined by the industry itself as an industry responsibility, can industry deliver on the solution?

William Looney, Editor-in-Chief

The three-year low demonstrates the receding trends of drug success, the amount of drugs entering Phase I and II trials and the number of new molecular entities (NMEs) launched in the global market.

Pfizer is a prime example. The firm’s R&D expenditure for 2012 is between $6.5 billion and $7 billion’ last year’s budget was between $8 and $8.5 billion budget. The areas in which Pfizer plans to cut R&D include allergy and respiratory diseases. Instead the key focus will be on vaccines, neuroscience, oncology, cardiovascular and inflammation treatments.

Another pharma giant slashing its R&D expenditure is GlaxoSmithKline. The company has downsized its Harlow R&D site and has claimed it will be wary of unnecessary R&D expenditure in areas such as depression, neuroscience and depression. Both Johnson & Johnson and Bristol Myers Squibb have reduced R&D expenditure by 2%.

The Factbook highlights that 21 NMEs were launched globally in 2010, compared to the 26 NMEs last year. Drugs entering Phase I and Phase II trials dropped 47% and 53%, respectively.

Phil Miller of Thomson Reuters, said: “High failure rates continue to be of great concern to the industry and this is compounded by the decrease in NMEs. The strategy of big pharma to in-license more drugs for development does not appear to be paying off at present. An earlier focus on clearing out weak drug candidates will be instrumental to successfully progressing drugs to market.”

On a positive note, clinical trials for anti-cancer drugs are experiencing growth and some industry experts believe that R&D productivity is, generally, quietly improving. Hans Poulsen, Head of Life Sciences Consulting at Thomson Reuters, said: “For the first time, drug companies are reducing costs in their R&D organizations and I believe we will see that trend continue. We could see an improvement but it may take four to six years before we can really say the trend has been reversed.”

Beth Kennedy

Last week brought a small but dedicated group of sales professionals to a CBI conference in San Diego with a clear mandate: to rate the future of the “detail man” — dead or alive?

Surprisingly, the consensus was that the function still retains its value, even as e-detailing and other online technologies are transforming the traditional way the industry interacts with healthcare professionals. One interesting data point is how provider attitudes toward working with sales representatives vary with the nature of the practice: survey research presented at the conference showed that while roughly a quarter of all physicians in the US now ban rep calls, including the bulk of all primary care professionals, 74 percent of specialist physicians still prefer that face-to-face contact.

What matters today is the relevance and quality of the interchange, and what physicians want most is the most current information available on the progress of clinical trial studies. This is no doubt a consequence of pressures from patients, which is why a key element in the curriculum of the new sales rep should be how to  build ties to disease groups and patient advocacy organizations. Another trend is making the rep more engaged in market access support through better awareness of the reimbursement policies and options set forth by payers. As this task of “fighting the insurance companies” takes a good deal of a physician’s time, the ability of the rep to synthesize and explain the rules on P&R can free the physician for the clinical interventions that save or extend lives.

The other topic for debate was the merits of GSK’s new formula for calculating performance bonuses among its US sales teams. It focuses heavily on informal feedback from healthcare professionals as to the quality and breadth of information received from the individual rep, rather than the traditional approach based on hard targets like scrip volume within each rep’s territory. GSK says its compensation plan will significantly reduce the potential for compliance problems, such as when sales reps skirt illegal behavior by promoting off-label prescribing.

That said, participants at the CBI event asked whether customer feedback is sufficient to ensure that the process of awarding bonuses will be objective and transparent. What happens when this subjective assessment of performance is at odds with the sales and revenue numbers? And does any of this really matter when payers are driving the agenda so completely in managing pricing and access?  There were no hard and fast answers, except for the premise that the safest ground is for the rep to link his own performance to the interests of the patient in getting timely access to the right drug at a reasonable price.

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end.

Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.”??Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

Walter Armstrong

YOUR COMMENTS:

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GlaxoSmithKline’s diabetes drug Avandia became mired in such controversy regarding its safety in recent years that it was dubbed “another Vioxx”—exactly what the pharmaceutical industry had vowed never to produce. Two weeks ago, FDA’s decided to restrict access to Avandia, earning it “drug of last resort” status. This long-awaited decision was expected, but there were many unexpected aspects to the way the agency made its decision public.

Pharmaceutical Executive asked Daniel Carpenter, a professor of government at Harvard University and the author of a big new book about FDA called Reputation and Power (Princeton University Press) that is getting a lot of attention in the press, for his take on how the Avandia story has played out—and what it may mean for both FDA and pharma in the future. Walter Armstrong

Pharm Exec: FDA decided to leave Avandia on the market and to impose a REMS that essentially turns it into a diabetes drug of last resort. (The drug already carried a black box warning about cardiovascular risks.) GSK has said it will no longer spend any money marketing Avandia, and most analysts agree that new prescriptions will likely come to a halt. So why didn’t the FDA, like the EMA, simply yank the drug?

Daniel Carpenter: I see the Avandia decision as a kind of withdrawal, with a very strong, long-term message for the pharmaceutical industry. Essentially 95 percent or more of the drug’s once-robust market is gone, and the decline is attributable almost entirely to post-marketing studies by third parties and a series of FDA regulatory decisions.

GSK’s decision to discontinue marketing for Avandia was not unrelated to FDA’s decision. My guess is that GSK had an implicit understanding that FDA would allow sales for existing Avandia patients without other alternatives, but only if marketing stopped to new patients.?The FDA can now use a REMS to carve out virtually all of a drug’s market while also satisfying medical libertarians by leaving it to be prescribed for the few who have no alternative. Some consumer advocates have decried the decision to leave the drug on the market. I see it differently: Avandia has been all but taken off the market, and a critical precedent has been established.

If I had told you four years ago that, in the absence of a single randomized clinical trial demonstrating greater cardiovascular risk for the drug, 95 percent of that drug’s market was going to be taken away by virtue of a meta-analysis and post-market epidemiology studies—plus some unsavory evidence revealed about a company’s clinical trial practices and failure to disclosure risk information—I think you would have bet against me.

Vioxx was pulled only when a randomized clinical trial demonstrated greater myocardial infarction risk. In some ways, given the evidence base, FDA’s decision on Avandia is a more aggressive regulatory action. It may well be the right one, but regardless, it’s momentous.

If I had to wager one other thought—based on this case’s circumstantial evidence—it’s that FDA’s leadership might be using Avandia as a try-out opportunity for a tougher REMS. Again, there is a real signal being sent to the drug industry that these REMS are not mere “management tools” but can be used to reduce a drug’s market to a fraction of the sponsor’s original ambitions.

Three aspects about the way the decision was communicated seemed surprising to me: First, FDA and the EMA made their announcements in a coordinated fashion.
Second, FDA posted on its website the memos written by John Jenkins at the Center for New Drugs, David Graham at the Center for Drug Safety, and other key officials, showing the dramatically conflicting views of their risk/benefit analysis of the drug.
Third, Commissioner Margaret Hamburg, Deputy Commissioner Josh Sharfstein, and CDER head Janet Woodcock co-wrote a piece in the New England Journal of Medicine explaining the difficulty of coming to a conclusive decision. Each of these actions was a remarkable departure from FDA tradition. They appear to speak to the new transparency at the agency, which seems to be a very high value of the Margaret Hamburg.

DC: I think you’re right about transparency being cherished by the new leadership. It’s being pursued for a number of reasons, not least because the new FDA leadership understands, in ways the past few commissioners did not, that the FDA’s credibility has been severely compromised in the last two decades.

The current FDA leadership also understands the symbolic importance of their actions, and I can only surmise that that understanding, plus the possible confusion caused by separate EU and US decisions, was the reason for the coordination with the EMA.  ?There are, of course, risks to transparency. In this case, by not presenting a united front to the public and the scientific community, people will perhaps begin to view FDA as characterized by massive infighting. That said, in an age when anyone can tweet, blog, talk to a reporter, and so on, I think Commissioner Hamburg understands that there is a greater risk from trying to present a united front when there isn’t one.

Her policy of transparency serves other purposes, too. It now forces people like Jenkins and Graham to come clean and public with their strong views. Graham had been doing that already, but this policy requires him and other drug safety officials to articulate their views on the same platform (scientific and administrative memoranda) shared by Jenkins and Woodcock, the people whom they regularly oppose. Jenkins’ view that Avandia needed essentially no further regulation had been articulated internally in the past, but from now on it has to be communicated openly and immediately.

So this policy may make it more difficult for people like Jenkins and Graham to maintain rigid stances. To keep credibility, they may need to pick and choose their battles.

GSK attempted to refute the charge that Avandia caused more heart attacks and other CV complications than other diabetes treatments by saying that the two most damning studies were both meta-analyses, while their own RECORD trial, which didn’t show an increased risk, was gold-standard randomized controlled trial (RCT). (Of course, their defense was demolished when an FDA investigator revealed that some of the outcome data in the trial had been dropped or faked.)Do you agree that the two different kinds of studies are too different to be usefully compared?

DC: On the memo from FDA reviewer Thomas Marciniak severely criticizing the RECORD trial, I have claimed elsewhere (Pharmalot, July 2010) that its effect was to undermine GSK’s credibility in running trials. That could have long-term damaging consequences for the company, especially when combined with the New York Times reports and the evidence coming from the Senate Finance Committee. The issue is not so much whether New York Times readers trust the company’s trials, but whether advisory committees and FDA and EU medical reviewers trust the company’s trials.

This question—the comparability and relative value of RCTs versus epidemiologic studies—is one of the critical issues facing 21st century governance and science of pharmaceuticals. It’s clear that RCTs are still preferable for many questions, but it’s also the case that other kinds of evidence (such as pharmacoepidemiology) are becoming more rigorous.

The question of internal and external validity is also very important. I tell my students that perhaps the most important medical and public health finding of the 20th century—that cigarette smoking causes lung cancer and heart disease—came entirely from observational studies.

One other thing. If we are truly entering a world where we care not just about a single average treatment effect, but instead a battery of treatment effects that differ by phenotype or genotype, then we are likely entering a world where observational studies are more—not less—important to the scientific inferences we make.

How would you characterize GSK’s approach to the entire question of its drug’s association with CV events, especially heart attacks. The coverage in the New York Times, in particular, of the documents GSK gave to the Senate Finance Committee paints the picture of a company almost trying its hardest not to get to the bottom of the problem—in fact, using tactics like intimidation of critics, hiding negative data from the public and even the FDA, and possibly paying doctors to fudge clinical data. Is that the grim reality of pharma’s methods?

DC: Large pharmaceutical companies have a severe trust deficit right now—in the public, in academic medicine and science, and among regulators and public health officials. And I daresay that trust deficit has been richly earned.

Every time another memo is leaked suggesting that risk information has been suppressed or shrouded, every time a critic has been bought off or intimated, every time a clinical trial has been oversold or sloppily analyzed, the reputation of the entire industry suffers. It really is a case of one bad apple ruining the whole bunch.

In my scholarship, I’ve noticed this kind of associative property of reputations and trust, where people who had nothing to do with success or malfeasance are nonetheless implicated symbolically in the success or malfeasance by virtue of their common membership in an organization or an industry.

Part of the problem is that we all inhabit a world where institutions and organizations generally have lost legitimacy. My own “sector”—higher education and places like Harvard—are not immune from this critique. But the reputation of the pharmaceutical industry seems to have fallen in a different way, by a different magnitude. If I had to name the top two or three issues facing pharmaceutical managers and executives over the coming generation, restoring public trust through circumspection and transparency would have to be one of them. This issue isn’t going away.

(Pharm Exec’s November issue will contain an in-depth interview with Daniel Carpenter about his 10-year study of FDA for his book, Reputation and Power, as well as some of the intense responses the book has already received in the media.)

Action by the Greek government to slash reimbursed drug prices by more than 25 percent has proved so draconian that some companies, led by Novo-Nordisk, say they refuse to drop prices, and are promising to withhold products or even withdraw from Greece entirely. Over the years, the industry has consistently avoided this “nuclear option” to avoid jeopardizing its reputation and license to operate with key regulators like the European Medicines Agency (EMA).

Harsh government and media reaction to what in their view amounts to the “abandonment” of Greek patients also threatens what is fundamental to current industry strategy in Europe—positioning itself as a health care insider and customer-focused “national champion” against the destabilizing forces of globalization. Any industry pushback begins from a constrained political dynamic: Can we point to the street riots that occur when governments announce cutbacks on drug spending, when compared to closing hospitals or laying off physicians?

Looking ahead, there are a number of scenarios that pose a negative outcome for industry. And these prospects will only accelerate in tandem with widening government deficits, compounded by a long-term public debt burden that for a majority of the 27 EU member states now exceeds the 60 per cent of GDP “sustainability threshold” set by the International Monetary Fund (IMF).

Removal of remaining political and institutional barriers to European-wide price coordination: Powerful new players are emerging in the regulatory space, led by the European Central Bank and the IMF; both support cutbacks in subsidized health entitlements against tax alternatives that might suppress economic growth. Each favors greater regional integration of fiscal policy drivers to maintain the viability of the Euro as a global currency, and leadership is not susceptible to influence by big pharma. More directly, the fiscal crisis provides a opportunity to expand the remit of the 1989 EU Price Transparency Directive, from what has primarily been a defensive tool advantageous to industry in promoting fair access to new drugs to a price monitor that will accelerate a “race to the bottom” in pricing based on a low benchmark covering all EU states. Country P&R data and strategies are now shared through the Directive’s Committee of member state P&R representatives; because at least 11 countries use Greek prices as a reference point in calculating their own prices, the impact of these deep cuts outside the country will be hard to contain, especially in mandating lower prices for affected medicines in at least two of the big five market countries: Italy and Spain.

A switch in cost-containment strategies—from limiting wholesale prices for new patented innovations to slashing volume growth: The latter is likely to carry a far more significant impact on the industry, particularly as diversification strategies now emphasize returns from reimbursed OTC medicines, generics and off-patent brands. In this regard, no access—by restricting the size of the reimbursement market itself—is a worse scenario than a lower price point. As France and other governments have noted, the easiest way to save on healthcare is to simply lowball a fixed budget on a commodity “silo” purchase like drugs. And just when the industry appears to be making progress in restricting legal recourse to parallel trade, interest in the tool could increase—although it is interesting to note that in the case of Greece, prices now may be too low to attract even the parallel traders.

A higher profile for the EMA as arbiter of product “value”: European drug legislation requires that any centrally approved medicine must be marketed and made available to patients in all EU countries; it is not left to the applicant’s discretion. This places the EMA in a position to question a company’s right to unilaterally withdraw a medicine based on narrow criteria like a low price. Expect as a corollary to this a revival of interest in formal “medical needs” clauses, which entail action by government payers to remove products from reimbursement on grounds that they don’t contribute to the standard of care.

Further globalization of the intellectual property and access debate: Far-fetched it may be, but it is possible that if Greece or other EU countries are confronted with companies that want to pull local access to medicines, they could seek to implement provisions of the 2001 World Trade Organization (WTO) Doha Ministerial Declaration on TRIPS and Public Health. Paragraph six allows countries to override company patent rights and compel local production of medicines to confront a public health pandemic or other situations of “extreme urgency.” The EU as a negotiating group renounced use of this option at the WTO, but there is no guarantee that one of the smaller EU members might raise it as a way to up the stakes and provoke an internal debate around the broader societal obligations of the industry.

The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that as yet hasn’t suffered from the same safety pitfalls. But with recent allegations of Avandia-research related misconduct from the Senate Finance Committee, and renewed unease about the drug’s safety profile, some researchers are wondering if the study places its subjects in harm’s way.

Glaxo has denied any suggestion of danger, and points to the study’s FDA-mandated structure and approval by ethics committees around the globe as proof of its safety and necessity. The company will have to wait until a July hearing to learn the fate of the trial—and possibly the drug itself, since further safety concerns in a study like this are inextricable from the drug’s safety profile, according to FDA’s principal deputy commissioner, Joshua Sharfstein.

But GSK can take some small comfort in the fact that it’s not alone: Pfizer received a warning letter just this week over one of its trials for antipsychotic Geodon (ziprasidone). The trial’s goal is to explore the drug’s use in bipolar children, but so far at least 13 of those subjects received enough medication to trigger an overdose, and the letter calls Pfizer out for failing to properly monitor the children. This comes after last year’s $2.3 billion settlement with the Department of Justice over illegal promotion of four drugs, including Geodon.

We typically don’t get emails from FDA  asking for information about stolen goods with massive bold letters, but that’s what just came into our inbox. Looks like a transport truck containing a mix of GlaxoSmithKline’s pharmaceutical and over-the-counter medications was jacked in Puerto Rico on January 29, and the feds are looking to the general public for any information. It’s curious that it took more than three weeks to announce the news. No word on whether the theft was just now discovered, or if they are reaching out to us because all other leads have run dry.

Below is a list of the stolen drugs. Please contact 1-800-551-3989 if you have any information about this incident.

NDC     Description     Lot #   Quantity

(Unit of Sale)
0173-0697-00    Advair Diskus 500/50mcg 60 Dose 9ZP2144 2
0007-5500-40    Albenza 200mg 112s      9B001   4
0007-3152-13    Avandaryl 4mg/2mg 30s   9ZP2540 48
0029-3159-00    Avandia 4mg 90s 9ZP2237 48
0029-1527-22    Bactroban Cream 15gm    C433259 160
0007-4139-20    Coreg 3.125 100s        MTSR1212        4
0007-3370-13    Coreg CR 10mg 30s       9ZP4771 96
0007-3371-13    Coreg CR 20mg 30s       9ZP0413 95
0007-3372-13    Coreg CR 40mg 30s       9ZP3661 224
0007-3373-13    Coreg CR 80mg 30s       9ZP3920 16
0173-0201-55    Daraprim 25mg 100s      A44519  3
0173-0470-01    Epivir 150mg 60s        9F004   3
0173-0470-01    Epivir 150mg 60s        9K007   9
0173-0662-00    Epivir HBV 100mg 60s    9D003   1
0173-0471-00    Epivir Oral 10mg/ml 240ml       9E003   12
0173-0719-20    Flovent HFA 110mcg 120 Actuation        F0638   48
58160-825-51    Havrix 720 ELU Tip Lok 10s      AHAVB371BA      1
0173-0260-35    Lanoxin Inj 0.5mg/2ml 50s       8M920   2
0173-0713-25    Myleran 2mg 50s 809980  1
0007-4883-13    Requip XL 6mg 30s       9ZP3419 2
0173-0750-00    Treximet 85mg/500mg 9s  8ZP2362 60