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“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

June 24, 2013 Posted by | Big Pharma | , , , , , , , | Leave a comment

“Safe And Effective”: All Women Should Have Quick, Confidential Access To Emergency Contraception

Earlier this week, the Food and Drug Administration took an important step for millions of women by moving emergency contraception out from behind the pharmacy counter and making it available to people ages 15 and older with valid identification.

As a doctor, I know that this is good news and a great first step. Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex. By reducing barriers, this announcement will help more women prevent unintended pregnancy.

At the same time, the Obama administration said this week that it is appealing last month’s federal ruling that would have eliminated the age restriction completely. Citing scientific research and evidence, the judge removed the age and point of sale restrictions that made it harder for all women to access emergency contraception. That ruling should stand.

Unprotected sex sometimes happens – a condom breaks or non-consensual sex occurs. When it does, all women, regardless of their age, need access to emergency contraception quickly and confidentially.

Remember, emergency contraception prevents pregnancy. The sooner it is taken, the more effective it is (but if you are already pregnant, it won’t work). That’s why removing unnecessary barriers that delay access can help a woman prevent an unintended pregnancy.

The research shows that emergency contraception is safe for women of all ages, including young people. Research also indicates that teens understand how to use emergency contraception and understand it is not intended for ongoing, regular use. It doesn’t increase risky behavior either.

A recent study published in the medical journal Pediatrics found that sexual activity is exceedingly rare among the youngest adolescents. However, when sex does occur among teens under 14, it is often non-consensual and contraceptives are not used.

So despite some of the myths out there, emergency contraception is a safe, effective way to prevent pregnancy for all women, regardless of age (though, as someone who talks to parents everyday about health care, I also know it’s crucial that parents have conversations with their children about these issues).

The good news is that this week’s decision makes it a whole lot easier for women to get access to emergency contraception. More should be done to remove all barriers and unnecessary hurdles. While the teen birth rates have declined significantly in the last two decades, they are still high, including in states that lack access to medical providers and preventive health care.

That’s why, as a doctor, I know it makes good scientific and medical sense to expand access to emergency contraception to all women.


By: Deborah Nucatola, MD, Senior Director of Medical Services for Planned Parenthood Federation of America, Debate Club, U. S. News and World Report, May 3, 2013

May 6, 2013 Posted by | Birth Control, Women's Health | , , , , , , , | 1 Comment

“Routine Securities Taken For Granted”: Essential Government Tasks Need Reliable Funding

Here’s hoping that Stewart Parnell goes to prison.

The former president of the now-bankrupt Peanut Corp. of America, Parnell ran a filthy Georgia processing plant contaminated with salmonella that injured more than 600 people in a 2008-2009 outbreak, killing nine. Last month, federal prosecutors charged Parnell and three others with criminal offenses, claiming the executives intentionally shipped out contaminated peanut products.

It’s about time that white-collar criminals whose actions result in death or horrible injuries have to do the perp walk, just like the leeches who sell narcotics to kids. Former workers and federal inspectors say the plant, located in the small southeast Georgia town of Blakely, was a breeding ground for bacteria — with a leaky roof, dirty floors, mold on the ceiling and walls, and rats and roaches everywhere.

Still, it’s not enough to know that Parnell is finally going before the bar of justice. I also want a vigorous and assertive government that will help ensure that plants like Parnell’s Blakely facility won’t be free to operate in the future.

With President Obama battling Republicans over government spending, it’s easy to forget the important functions that federal agencies carry on every day. The Washington commentariat has concluded the agreement — known as “sequestration” — that produced shortsighted budget cuts hasn’t caused any harm to the majority of Americans, an indication, in that view, that Obama oversold the consequences of the cuts.

Is that true? The fact is we may never know how much harm will be done by those cuts. We don’t know how many children will miss their vaccinations, how many Head Start teachers will be laid off, or how many food inspections will be skipped.

The line between cause and effect is especially hard to draw in the work of those federal agencies whose jobs are aimed at prevention. The inspectors at the Food and Drug Administration have done their jobs well when you don’t hear of a food-borne illness or a faulty medical product. That sort of work is essential, but its results are hard to measure. And it never attracts public attention of the sort that ensures big budgets.

After the Blakely fiasco, Congress passed laws beefing up the powers given to the FDA. The agency used that new authority to shut down a New Mexico peanut processing plant that was implicated in a 2012 salmonella outbreak.

That decision came after the FDA, the Centers for Disease Control and Prevention (another federally funded agency) and state and local health departments tracked the outbreak to that specific plant, run by Sunland Inc. That outbreak sickened dozens.

I don’t know — and neither do you — whether the CDC will continue to have all the resources it needs to track deadly diseases with the across-the-board spending cuts dictated by GOP intransigence. I don’t know whether the Consumer Protection Agency will be able to track down all the lead-tinged toys coming in from China. I don’t know whether the FDA will be able to shut down the next Sunland before hundreds are hurt.

But I do know this: When I fix my 4-year-old a peanut-butter-and-jelly sandwich, I should not have to worry about whether she’ll get food poisoning. When you buy peanut butter crackers from a convenience store to placate your growling tummy on a road trip, you shouldn’t fear that eating them will send you to an emergency room.

Those are routine securities that we take for granted because we live in an affluent, developed nation with government regulations for food safety. However, those protections cost money. They don’t come free.

I’ve eaten in countries where there were no pesky government regulations keeping the milk pasteurized and the water free of parasites and the cooked meat free of harmful bacteria. I’ll take more government — with its higher costs — any day.


By: Cynthia Tucker, The National Memo, March 9, 2013

March 10, 2013 Posted by | Public Health, Sequestration | , , , , , , | Leave a comment

A Progressive Defense Of The White House On Plan B

I get the reasons for liberal outrage at the Obama administration’s Plan B decision. But I can’t quite join in the indignation. I know that I am a man—a fact I’ve been aware of for some time—and so readers male and female can factor that in here as they wish. But it seems to me that to call this merely a case of politics cynically trumping science is way too dismissive of some concerns that parents with all kinds of political views might have about their teenage daughters buying this pill without their knowledge.

Much of the opposition to allowing underage girls to buy the pill over the counter amounts to straw-man arguments. There’s the line that taking the pill amounts to abortion. Watch this lurid ad by a right-to-life group and think about what sort of cacophony must be raging inside the mind that could even come up with such an egregious thing. Outside the realm of anti-abortion fanaticism, I don’t think most of us would equate the prevention of a pregnancy with the removal of an existing fetus. It’s called “emergency contraception” because it’s contraception, not abortion.

There’s also an argument about harmful effects on young girls of the pill’s heightened progesterone levels. I am far from being an expert on such matters, but unanimous view of the scientific community appears to be that the pill is safe for all females of child-bearing age, and that’s good enough for me.

Those are ideological issues, and ones that can be dismissed easily. But it seems to me that there is a fair issue here, and it has to do with parents having a right to know about and be involved in what their kids are up to. You simply don’t have to be a right-winger to have concerns about your 14- or 15-year-old daughter having easy access to such a pill.

That is not a political question per se. A parent’s view on that matter will be partially informed by politics, but only partially (and in some cases not at all, since lots of people have no political views to speak of). Parents’ opinions on this will be informed most of all by the parent-child relationship; by the parents’ views about sexuality and morality; by the parents’ feelings about their authority vis-a-vis their child’s autonomy. These areas might have a lot to do with a parent’s political views, but they might not. We all know people who are politically conservative but sexually libertine, or politically liberal and as chaste as Mother Teresa.

In other words, this is less about appeasing the right than acknowledging reality in all its complications out there in the country, where many people probably have mixed feelings. I’d be fascinated to see some polling on this, and I expect we will soon.

In an ideal world, parents would rationally support the idea of their daughters having every means available to them to correct an error (or, obviously, to override a violation) that happened a day or two prior. But parents don’t always think rationally about these things. That makes these issues sensitive by definition, and it’s hardly illegitimate for a government to take such matters into consideration. I’d have had more respect for Kathleen Sibelius in this situation if, instead of that blather about 11-year-old girls not being able to follow instructions and take the pill properly, she’d just said: “Look, I respect the science, but this raises ethical and moral questions about what is the proper age for access to emergency contraception, in addition to the scientific ones. And that’s a public debate we ought to have more of before we pull this trigger.”

Such pills are generally available in other advanced countries, but there are some limits. In England, you have to be at least 16 to buy them. In Finland, 15. In Quebec, you have to consult a pharmacist. In Italy, it requires a doctor’s prescription.

So advanced societies haven’t yet made an across-the-board decision that all girls from 11 up should be able to buy this pill, and the United States always lags behind in these things, for all the reasons we know.

I wouldn’t doubt that the administration feared the development of a narrative here. Newt Gingrich in particular is very adept at that sort of thing: This election, he’d have announced with his usual fanfare, is a contest between traditional values and 13-year-old girls having no-consequences sex. It’s hard to know the extent to which that would have taken off.

But I doubt this was just politics. It was only in August that this same “anti-woman” administration issued new standards requiring insurance companies to cover all government-approved contraceptives for women, without co-payments or other fees. That will take effect, under the new health-care law, in January 2013 and should go a long way toward lowering the cost barriers to birth-control services for insured women. If the administration so lives in fear of political fallout from the cultural right, then why did it do that?

So maybe there was something more going on here. Maybe we should have a longer debate about the appropriate age at which this pill should become available. And maybe the right answer, an answer that much, but not all, of the advanced world has agreed on, is that there shouldn’t be a limit. The science says it’s safe, and it will undoubtedly prevent unwanted pregnancies—and, in an irony that the anti-abortionists never grasp, it will prevent abortions, too. But it’s now the job of advocates to make the culture catch up to the science.


By: Michael Tomasky, The Daily Beast, December 9, 2011

December 11, 2011 Posted by | Abortion | , , , , , , | Leave a comment


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