Friday, June 3, 2011

Got Meds? Not Necessarily, Say U.S. Hospitals

WRITTEN BY BEVERLY K. EAKMAN
FRIDAY, 03 JUNE 2011 14:37

Over the Memorial Day weekend, while many were getting their first taste of summer — ergo, not reading the news — it was reported that U.S. hospitals were experiencing shortages of both common and specialized drugs, so much so that they are looking for substitutes and combing the globe for overseas suppliers. An Associated Press story announced that some “89 drug shortages occurred in the first three months of this year, according to the University of Utah’s Drug Information Service (UUDIC)…which tracks shortages for the American Society of Health-System Pharmacies.”

Turns out, this is not a new problem. According to Linda S. Tyler, Pharm. D., FASHP, Pharmacy Manager, Drug Information Services, University of Utah Hospitals and Clinics, the first drug shortages in the United States occurred in 1996, during the Clinton Administration, when data collection on the topic began. At the time, there were only five drugs affected, but that number rose swiftly to 20 drugs between 1997 and 2000, according to UUDIC tracking. In 2001 the number of shortages grew to 120, most of which were resolved by the following year because they didn’t rise to the level of adversely affecting hospitals and patient care. Today, that has changed.
Shortages are not only inconvenient, but expensive. Tyler wrote that “[c]hanges in drug supply can alter the way medications are prepared in the pharmacy, the way they are administered to patients, and, in some cases, whether patients receive medications at all.” She estimates that “many organizations spend between one-half and three full-time equivalent (FTE) personnel on the management of drug shortages. These extra FTEs spend their time investigating the reason for the shortage, finding alternative agents, working with wholesalers, finding alternative suppliers, compounding a replacement product internally, or communicating with other practitioners.”

The knee-jerk public response to this news is along the lines of: Do we make anything in this country anymore? Is there anything that is not still outsourced, imported, or subject to rationing?

The real factors are more complicated, and more disturbing. In 2003, Tyler categorized several reasons for shortages, summed up as regulatory issues (7 percent), product discontinuation (20 percent), raw materials issues (8 percent), manufacturing problems (28 percent), and supply-and-demand (10 percent). In her updated publication, Tyler notes that this leaves some 27 percent of shortages unexplained. Deeper, more hidden, reasons include “Grey” Market Vendors, Prime Vendors and Just-in-time Vendors, Industry Consolidations, Market Shifts, Manufacturer Rationing, Restricted Distribution, Manufacturer Discontinuation — and the fact that sometimes drug companies are loathe to reveal the details of shortages for fear of a public, legal or other backlash.

Most of these categories appear to be self-explanatory, although the motives pretty much revolve around demand (read: money). Thus persons with legitimate, but rare, disorders who rely on particular drugs may find their doctors hard-pressed to locate a new source or alternative (the National Association for Rare Disorders helps), while well-hyped, trendy complaints (like attention-deficit “disorder” and depression) see a new pill on the market several times a year. War is certainly a factor, when soldiers require an unexpectedly large quantity of a certain product, creating temporary shortages in the U.S.

But “grey market vendors” are more troublesome. Tyler explains that “the profitability of [certain] pharmaceuticals attracts vendors who [then] create artificial shortages by selectively purchasing excessive quantities of products, … thereby depleting the available stock. These vendors then re-sell the products back to the users at inflated prices.”

“Prime Vendors and Just-in-Time Inventories” are another development that makes for concern. Tyler explains:

The increased use of prime vendors may have contributed to the drug shortage situation by reducing the amount of product available in the supply chain. It is no longer easy to weather shortages by relying on stockpiled inventories because both wholesalers and health systems maintain minimum levels of stock. As a result, manufacturer supply issues are transmitted directly to the user without the benefit of an inventory buffer, thereby increasing the number of short-term shortages that may impact [larger] institutions.

The practice of maintaining minimum supply levels could be disastrous, especially as we contemplate bio- and chemical weapon attacks, not to mention out-sized, super-toxic strains of E. coli that have now killed some 18 Europeans and sickened 1,600 via an unknown, salad-vegetable-borne contaminant. Persons who get any E. coli infection can suffer horribly (somewhat reminiscent of Hemorrhagic Fever (Ebola)/Renal Syndrome [HFRS]), as this one attacks the kidneys, too, and is apparently drug-resistant.

Furthermore, many of the drugs that are ubiquitous and easy to get are also the most misleading (e.g., Exedrin Migraine and Extra Strength Exedrin contain identical ingredients, including the percentages of each compound; Eli Lilly’s antidepressant Prozac gets only a new color (pink) and a new name (Sarafem) for treatment of so-called premenstrual dysphoric disorder (PMDD), dubbed a mental illness in women.

Warehousing medicines are not in the same category as warehousing books. A case can be made for no longer warehousing books, as computerized printing and the Internet have made doing so unnecessary, given easy on-demand operations. Warehousing medicines, however, is critical, even as a stop-gap measure until a better drug can be researched.

Moreover, the medical and pharmaceutical community may need to work to get a handle on the supply-and-demand problem quickly, giving the heave-ho to misrepresented drugs and quick approval and distribution for critical ones, including those for rare diseases. Shortages are not an option.

Conservatives Lose Ground on Social Issues


The Agenda Game: Part I -
FRIDAY, 03 JUNE 2011 00:04 BEVERLY EAKMAN

Conservatives and traditionalists appear to be hopelessly outclassed when it comes to organizing and strategy. How else to explain the lack of bang for the conservative buck, even with umpteen nonprofits, volunteer groups and lobbying organizations devoted to promoting a traditional approach to social issues? Inboxes overflow with “urgent” admonitions to contact members of Congress over one issue after another: the Defense of Marriage Act, gays in the military, women on submarines, pro-homosexual curricula. This past May, it was the politically-correct censorship of six year-olds (“Candy Cane Case”) and transgendered classrooms.

The very concept of marriage now appears to be in trouble—a cornerstone of the pro-family, conservative movement—even as celebrities brag on and on about conceiving out of wedlock. Focus on the Family President Jim Daly, in an interview just published in WORLD magazine, allowed that pro-family leaders probably are losing the battle for traditional marriage among younger generations of Americans, “as casual ‘hookups’ continue to replace the romance of dating”. A combination of factors has contributed to this result: teen magazine articles; hypersexual advertising; and age-inappropriate, graphic sex education. The one in four girls reported to have had a sexually transmitted disease (STD) in 2008 hasn’t changed much from year to year—a little more among some demographics one year, a little less in others.

Any way you look at it, promiscuity is pervasive, and risky sexual behaviors increasingly are expected and normalized, despite the emotional and physical toll on girls, in particular.


Then, there are ongoing issues like crime, low academic performance, loss of personal privacy, the practice of sending naughty and/or “slow” children to psychiatrists for therapy and drugs, human trafficking and dozens more that have seen little or no gain for traditionalists since heaven-knows-when.

Even when we win one, it’s soon back to Square One. For example, the organization MassResistance gleefully reported May 23, that Kevin Jennings will be leaving his post as the U.S. Department of Education’s “Safe Schools Czar” this coming July. Jennings has been the driving force behind pro-homosexual curricula and “tolerance,” as well as founder of the Gay, Lesbian, Straight Educational Network (GLSEN), which has so much money invested in getting its message out that it even managed to register-trademark (®) its own slogan. Jennings is credited with helping to introduce Bill 4530 in Congress that would require normalization of homosexuality, transgenderism, cross-dressing, etc., in America’s public schools. (Two copycat “transgender” bills at the state level are already taking a toll in California schools; AB 433 and SB 48 are poised to be passed by the California Legislature, but at least one elementary school in Oakland is already indoctrinating kids starting in kindergarten about “gender diversity.”)

No sooner had Jennings announced he was exiting as Safe Schools “czar,” than he was slated to head up an outfit called Be the Change, described by MassResistance as “a turbo-charged community-organizing organization founded by well-known Massachusetts liberal activist Alan Khazei,” who is poised to run for U.S. Senate against a Republican. Khazei, a fellow whom most conservatives never heard of, founded City Year in 1998 as a program for organizing youth, in the spirit of Hitler’s Youth and the communists’ Comintern and Young Pioneers, his goal being to “put their idealism to work” through “community transformation.” (This is the type of “community activism” Barack Obama cut his teeth on in Chicago.) The organization now has 22 offices across the US, and also in places as far removed as London and South Africa, given its slew of high-profile corporate sponsors. Jennings’ new role will not only give him access to Khazei’s fortune and influence, although he may have had it all along, but he will now be poised to include adults and take City Year to even greater heights once he takes the reigns of Be the Change.

With the 2012 election less than a year and a half away, conservatives are asking why things like this keep happening. Why, they wonder, can’t conservatives slam the lid shut whenever a new radical activist-turned-“expert” comes out of the woodwork?

They are finding that, just as housing prices are all about location, location, location, success in politics is all about strategy, strategy, strategy. Conservatives keep trying to recycle the same strategies—and sometimes even the same candidates—year after year. That is one factor in the rise of the Tea Party: the feeling that it’s time for some new blood.

It’s not that conservative ideals are blown off by the public—in fact, most Americans, when push comes to shove, actually identify more with the traditional social mores than not. Polls show that most people value their privacy; they don’t want to be snooped on. They zealously guard what they see as personal property. They expect schools to turn out knowledgeable kids and to instill discipline, not just kids who will be “team players.” They still admire the traditional white wedding, and they’re a bit squeamish about sharing bathroom and sleeping quarters with homosexuals.

So, what exactly is the problem?

It’s the hostile political environment. By the mid-1980s, even with the Reagan Revolution in full gear, the Marxists and anarchists of the 1960s had been trained to carry the day. They became the wealthy, the focused, the movers and shakers. They knew exactly how, and where, to invest their money (media, media, media) and learned to push conservatives’ hot buttons over and over so that traditionalists were left flailing about, hopelessly divided, at each other’s throats, disorganized and angry.

For 35 years, the left has used “the dog-bone strategy.” It tosses one outrageous issue after another to conservatives, and the conservatives always bite. Today, “medicinal” marijuana, tomorrow government bail-outs, the next day gay pride, and the day after that universal government health care. Pretty soon conservatives are left sputtering, grasping at straws, desperately latching on to something they hope will be the issue that carries them to victory—Medicare, school “standards,” energy shortages, taxes. They rarely have time to think anything through, so as to have something substantial to bring to the public table. Just about the time they do get a proposal together, they get kicked into another outrageous “crisis” that must be addressed—right now!

Every month, conservatives must seize a new crisis—climate change, the deficit, sex scandals—launching yet another pitiful exhibition of outrage, while the left-wing laughs all the way to …well, the presidency.

Many conservatives now realize they need to change the dynamics of this game. They know they must take the debate—and the agenda—away from the Left and devise a means of getting the leftist-liberal-anarchist cabal to debate on conservative turf. To do that, conservatives must first figure out where the conservative turf is.

That topic will be taken up in Part II in this series.