“How Safe Are Pharmaceutical Supply Chains?”: An Organizational Mindset Is Necessary, Even If Costly In The Short-Term
GlaxoSmithKline announced this week that it is recalling some of its asthma drug Ventolin. The reason: its contract manufacturer said that the syrup bottles might have been contaminated with glass particles.
Last fall, in what 60 Minutes described as “the worst pharmaceutical disaster in decades,” 48 people died in a meningitis outbreak that was traced back to contaminated production in a compounding pharmacy in Massachusetts. The New York Times reported that the U.S. is suffering from a shortage of injectable drugs caused by quality failures at large manufacturers such as Hospira.
As a result of these and other stories, the quality of our medicines, or more precisely the failure in quality, has gained widespread attention.
Many believe the solution is to increase business investment in capital equipment. Hospira announced last year that it would spend hundreds of millions of dollars on a new state-of-the-art plant and quality and operations specialists. David Gaugh, vice president for the Generic Pharmaceutical Association, said that the perception that injectable drugs are produced in run-down facilities was “absolutely not true” and compared them to well-maintained vintage cars. This focus on technology might appear reasonable; but it is not sufficient.
The only way to guarantee that no defective drugs are ever produced is to never produce any drugs. None of us wants a world without medicine, and thus, we must live with some risk of quality failures in our drug supply chains. Because testing pharmaceuticals for every theoretically-possible contaminant or process deviation is prohibitively expensive if not impossible, drug quality must be built into the product through well-designed production processes, the use of quality ingredients and the consistent adherence to quality control procedures.
Aware of this, regulators long ago established “Good Manufacturing Practices,” known as GMPs, in the pharmaceutical industry. Operating in full compliance with these legally-required GMPs greatly reduces the risk of contaminated or misformulated product reaching the market. It seems that many of the plants highlighted in recent reports were not adhering to GMPs.
To address the problem, it is necessary that executives develop a quality-oriented mindset across the entire supply chain. For example, are employees empowered and encouraged to report deviations from GMPs, even if doing so is costly in the short term? Are deviations investigated and corrective actions put in place, even if doing so requires failing to meet promised delivery dates? Absent such an organizational mindset, quality failures will occur even with the best technology.
This soft side of quality management does not come easily. It often takes years of time to embed in a company, and even a longer time to regenerate if the culture has been undermined. Our research (with co-authors) has found that is difficult for companies to prevent a “decay” in GMP adherence even in their own factories.
When production is outsourced, ensuring adherence is more challenging. Recognizing this, the Food and Drug Administration is currently seeking comment on a “Guidance for Industry” document on quality agreements in contract manufacturing. The document focuses on clarifying responsibilities. Most companies engage in some form of certification, facility audits and product inspections with their contract manufacturers. While clear responsibilities and such actions can help to ensure quality at contractors, they do not guarantee consistent day-to-day adherence to good manufacturing practices.
Using FDA inspection data, we (and co-authors) have studied quality risk in the pharmaceutical industry. In one set of studies, we found that plants in a location with a different primary language than the firm’s headquarters operate with less GMP compliance than those with no language difference. Regarding outsourcing, we did not find an overall difference in quality risk between company-owned plants and contract manufacturer plants.
However, we did find a higher quality risk for small contract manufacturers and those subject to less regulation. Given this, we were not altogether surprised that these lightly regulated, small compounding companies like NECC were found to operate with high quality risk.
Taken together, our research provides empirical evidence that drug manufacturers are hard-pressed to consistently maintain high quality operations even in their own domestic facilities. This challenge is magnified when production is performed in offshore and outsourced plants. Our study and related studies reinforce the recent call to increase FDA regulatory scrutiny of compounders; this is clearly necessary and will help prevent future tragedies such as the recent meningitis outbreak.
However, regulatory and technical solutions alone are not adequate—an organizational mindset of compliance with GMPs is necessary throughout a drug’s supply chain, even if developing and maintaining this mindset is costly in the short-term.
By: John Gray, Aleda Roth & Brian Tomlin, U. S. News and World Report, June 21, 2013
“Flapping In The Wind”: For John Boehner, It’s Job Security Vs Legacy
House Speaker John Boehner stopped by the Hyatt Regency on Capitol Hill on Thursday afternoon to pitch a gathering of the National Association of Manufacturers on the Republicans’ plans for jobs and growth.
“While my colleagues and I don’t have the majority here in Washington,” the speaker vowed, “we will continue to pursue our plan.”
Or will they?
Not an hour after those words were uttered, Boehner’s House Republicans dealt him the latest in a series of humiliations. Sixty-two Republicans defied him and voted against the farm bill, defeating a major piece of legislation Boehner had made a test of his leadership by pushing for it publicly and voting for it personally — something speakers only do on the most important bills.
The dispute this time was over food stamps and agricultural subsidies, but the pattern was the same: House leaders lost Democratic support by tilting the bill to satisfy the Republican base, but a group of conservative purists remained upset that the legislation didn’t go far enough.
Much the same dynamic confronts Boehner as the House prepares to take up immigration legislation next month. A similar set of pressures has kept Boehner from negotiating a long-term budget deal with the White House.
In all instances, Boehner faces a choice: his job or his legacy. He can enact landmark compromises but lose his job in a conservative coup. Or he can keep his job but get nothing much done.
With a few exceptions — the “fiscal cliff” deal, Hurricane Sandy aid — Boehner has chosen job security over achievement. He did it again this week on immigration, announcing that he doesn’t “see any way of bringing an immigration bill to the floor that doesn’t have a majority support of Republicans.”
That promise, which is essentially the same as saying he won’t allow the House to take up legislation that includes a path to citizenship for illegal immigrants, puts him on a collision course with the Senate, where a fresh compromise on border security negotiated by Republican Sens. Bob Corker (Tenn.) and John Hoeven (N.D.) make it likely that chamber’s legislation, which includes citizenship, will have a large bipartisan majority.
Boehner’s stance blocking an immigration compromise may preserve his speakership, but it would keep his party on what Sen. Lindsey Graham (R-S.C.) calls a “demographic death spiral” as Latino voters shun the GOP. Beyond the party, Boehner’s position raises the likelihood of failure on another high-profile issue for a Congress that continues to reach new lows in public esteem. Gallup last week found Americans’ confidence in Congress at 10 percent, the lowest ever recorded for any institution.
And that was before Thursday’s farm bill debacle, which saw lawmakers debating all manner of parochial items — olive oil, hemp, Christmas trees, shellfish, even a dairy amendment involving Greek yogurt sponsored by the aptly named Rep. Bob Goodlatte (R-Va.) — before killing the whole bill.
The bill, which had been awaiting action for a year, was never going to get much Democratic support because of $20 billion in cuts to food stamps. But Republicans lost what support they had on Thursday when they passed an amendment, opposed by all but one House Democrat, adding new work requirements to the food stamp program. That left only 24 Democrats on board, not close to enough to offset the dozens of Republicans who wanted the deeper cuts demanded by conservative groups such as the Club for Growth.
The agriculture committee chairman, Frank Lucas (R-Okla.), pleaded on the floor for colleagues to “put aside whatever the latest e-mail is” and vote with him. “And if you don’t,” he added, “they’ll just say it’s a dysfunctional body, a broken institution full of dysfunctional people.”
After the farm bill went down, Majority Leader Eric Cantor (R-Va.) came to the floor to blame Democrats for the collapse — an argument that might have made sense if Republicans hadn’t just forced through an amendment Democrats called intolerable.
Steny Hoyer (D-Md.), the minority whip, reminded Cantor that “25 percent of your party voted against the bill . . . and your side’s going to continue to blame us that you couldn’t get the votes on your side.” Hoyer invoked Newt Gingrich’s 1998 speech calling conservative holdouts in the House “the perfectionist caucus.”
Gingrich did indeed call the Republican hard-liners perfectionists and “petty dictators.” He soon lost his job as speaker, in part because of that remark, but by then he had reached compromises with a Democratic president that righted the government’s finances.
It’s an example Boehner would do well to recall.
By: Dana Milbank, Opinion Writer, The Washington Post, June 21, 2013
“Well Shut My Mouth!”: Paula Deen Played With Fire And Got Burned
I take no pleasure from the trouble food “personality” Paula Deen got herself into this last week, culminating in her firing by the Food Network after she stumbled through efforts to save herself via heavily massaged apologies. I admit to have enjoyed a couple of her recipes over the years. And I usually found her over-the-top “Well Shut My Mouth” embodiment of outworn southern cultural stereotypes annoying rather than deeply offensive–just another Cracker playing the fool for the tourists, basically.
But as a Cracker myself, not that much younger than Deen, I know that she cannot plead ignorance or even innocence of the dynamite of the South’s racial history, and how perilously and inherently her own Old South shtick has skirted the thin line that separates the light side from the dark side of our heritage. The Southern Cooking Icon who occasionally forgets she needs to play error-free baseball when it comes to race is a lot like the southern white politicians who occasionally forget they represent African-Americans.
Paula Deen will do a lot to redeem herself if she refuses to let herself be used as a martyr to the cause of anti-anti-racism–a victim of “political correctness” and all that. The campaign is already developing:
Todd Starnes, who also hosts a Fox News Radio segment, wrote on his Facebook page that the “liberal, anti-South media is trying to crucify Paula Deen. They accuse her of using a derogatory word to describe a black person. Paula admitted she used the word — back in the 1980s – when a black guy walked into the bank, stuck a gun in her face and ordered her to hand over the cash. The national media failed to mention that part of the story. I’ll give credit to the Associated Press for telling the full story.”
Starnes also defended Deen via Twitter, writing: “The mainstream media hates Paula Deen […] I think it’s because most of them don’t eat meat.”
Oh good God. The multi-millionaire celebrity Paula Deen is hardly up there on the cross, and I can testify there’s at least one white southern carnivore–a biscuit eater as well–who thinks that those who work so hard to identify themselves with southern cultural stereotypes are courting controversy and disaster if they don’t watch their mouths. There are many, many southern white chefs and TV stars and book authors and even politicians who don’t set themselves up as regional paragons, yet also manage to steer clear of discrimination suits and admissions of casual, “innocent” racism. Paula Deen played with fire and got burned. She can best heal herself by refusing to be used by those who aren’t “innocent” at all.
By: Ed Kilgore, Contributing Writer, Washington Monthly Political Animal, June 22, 2013
“Edward Snowden Blows It Big Time”: Crossing A Major Line To Further His Own Self-Aggrandizement
While it was inevitable that there would be those who support and those who condemn the initial disclosures of Edward Snowden—the 29 year-old former NSA contractor who disclosed the agency’s telephone and electronic communications surveillance programs—the tide of public opinion may be rapidly turning against Snowden…and with very good reason.
Spilling the beans to his fellow Americans over the depth of surveillance being carried out by the National Security Agency within the borders of the United States is one thing—disclosing the nation’s covert activities involving spying on other nations is something else entirely.
Last week, Snowden turned over documents to the South China Morning Post revealing that the United States has been hacking into Chinese computers—a revelation that came at a particularly embarrassing moment for the U.S. President who was busy castigating his Chinese counterpart for China’s constant intrusions into our own computer banks for various purposes, including the theft of American intellectual property. If that wasn’t enough, the Guardian newspaper followed up with a report provided by Snowden revealing that the Americans and British spied on various delegates attending the G20 conference in 2009, choosing to disclose this bit of information right before the start of this year’s G8 conference held in the U.K.
Anyone think much got accomplished at the G8 after that little gem was brought into the light?
Even more disturbing is what appears to have motivated Snowden to expand his leaking beyond the borders of the United States and into the world of foreign espionage.
Despite making a pretty good living for quite a few years through his employment as a small cog in the gears of government surveillance activities, Snowden declared, during a live chat with the Guardian on Monday, that he believes that “all spying is wrong.” And because it is Snowden’s personal judgment that all spying is wrong, he also believes it appropriate that he reveal our covert activities to affected foreign governments without a shed of concern for what the rest of his fellow Americans might think about this.
I don’t recall there being an election where I voted to assign my proxy to Edward Snowden so that this 29 year-old guy—who I never heard of before two weeks ago—could determine, on my behalf, what this country should or should not be doing when it comes to its covert, overseas spying program.
So, how is it that Mr. Snowden has decided that it is appropriate to appoint himself the arbiter of judgment and morality when it comes to such issues? How is it that Snowden has determined that he is providing me with some patriotic service when I neither asked him to do so nor agree that disclosing information on foreign spying is, in any way, a service to his nation or to me personally?
With his decision to move beyond informing his countrymen of surveillance activities that allow the government to track our telephone calls and emails, Edward Snowden not only crossed a major line but gave us all reason to feel considerable concern about his motives and purposes.
In discussing the rationale for his disclosures on foreign spying, Snowden said:
“When NSA makes a technical mistake during an exploitation operation, critical systems crash. Congress hasn’t declared war on the countries — the majority of them are our allies — but without asking for public permission, NSA is running network operations against them that affect millions of innocent people. And for what? So we can have secret access to a computer in a country we’re not even fighting? So we can potentially reveal a potential terrorist with the potential to kill fewer Americans than our own Police? No, the public needs to know the kinds of things a government does in its name, or the ‘consent of the governed’ is meaningless.”
There appears to be no shortage of logic fails in Snowden’s remarks.
If the public knows the details of what our government is doing when it comes to spying on foreign governments—as Snowden suggests is necessary—then it wouldn’t be covert spying activity, now would it? Spying is not particularly effective when everyone knows the target and nature of such a program.
And while Ed Snowden may have decided that all spying is wrong, I strongly suspect that the overwhelming majority of Americans would very much disagree with his assessment and might appreciate his not complicating our lives in furtherance of his own self-aggrandizement and the soothing of whatever crisis of conscience he may be experiencing.
What should further concern us all is not just that Edward Snowden has decided that we must now live with his judgments and moral determinations when it comes to how we conduct foreign policy, but that those judgments are based on a shocking degree of naiveté as Snowden doesn’t seem capable of grasping that in the world in which we live, our allies are not always our friends.
Snowden also appears to have missed civics class on the day when it was explained that the United States is a Republic where we elect people to make decisions on these matters and then judge the effectiveness of those decisions by deciding who we will keep in office and who we will turn away.
The bottom line here is that I really don’t care if Ed Snowden thinks all spying is wrong and neither do most Americans. This being the case, I have considerable difficulty with his decision to disclose the nation’s secrets to foreign governments just because he could.
I do care what the President thinks about our foreign spying operations just as I care about what Congress and the Judiciary think. It is their opinions and practices that I can either support or reject when I show up to vote. And while I may appreciate Mr. Snowden’s decision to inform his countrymen of surveillance programs involving spying on Americans, there is no claim nor evidence that spying on foreign entities crosses any legal lines and, therefore, it is incredibly wrong for Snowden to reveal data involving our spying programs outside the country .
Until I cast a vote for Edward Snowden to make such determinations for me, I would very much appreciate it if he would shut up and get over whatever psychological complexes are driving him to make these decisions on my behalf. He is doing neither me nor the country any favors.
By: Rick Ungar, Op-Ed Contributor, Forbes, June 20, 2013
“The Eric Cantor Story”: Waste, Fraud, And Abuse
The farm bill was defeated in part because they got fewer yea votes out of Democrats than they were hoping for. This happened, according to moderate Democrat Collin Peterson of Minnesota, because of a last-second amendment from Eric Cantor that sought to impose sterner work requirements on recipients of food stamps. Democratic whip Steny Hoyer says it took a bipartisan bill and turned it into a partisan bill.
This was just a cat-piss mean amendment that you have to think was almost designed to push Democrats away. Fraud in the food-stamp program (known by the acronym SNAP) is a frightening 1 percent, according to Think Progress. And existing work requirements are pretty stringent already. If you live in Cantor’s Virginia and want food stamps, here’s what you have to do, according to the state’s web site:
If you are age 18 to 50 and able to work, you may be subject to a work requirement in order to receive SNAP. This requirement would limit the number of months for which you could receive SNAP to three months in a 36 month period. After you receive SNAP for three months, you may be able to receive three additional months if you complete certain work related requirements. You may be exempt from this work requirement if you are currently working or participating in an approved work program; responsible for the care of a child; pregnant; medically certified as unable to work; meet one of several work registration exemption reasons; or live in an exempt locality.
I can’t find what these “certain work requirements” are, but it seems to me that having to re-meet them every three months provides a pretty constant check on people and meets a high standard of being responsible with the taxpayers’ money.
It’s just amazing to me the way they keep finding new ways to kick poor people. One, deregulate everything so that banks can start placing bets against their own securities. Two, destroy the economy, so that millions more people lose their jobs and have to go on food stamps in the first place. Three, decide that poor people have to pay the penalty for all this financial hanky-panky, and cut the federal programs they depend on to the bone. Four, cut food stamps even more, and make the recipients work more.
“Waste, fraud, and abuse” describe Eric Cantor’s contribution to this nation, his character, and his attitude toward people who aren’t rich.
By: Michael Tomasky, The Daily Beast, June 21, 2013
Share This Blog
Unknown Feed- An error has occurred; the feed is probably down. Try again later.
