Categorized | National, State

What a Failed Vegas Sex Pill and The Meningitis Outbreak Have In Common

 

Part II: Compounding Pharmacies and Lack of FDA Oversight Led to National Meningitis Outbreak

 

By Marshall Allen
ProPublica, Oct. 10, 2012

 

Imagine my surprise when I heard about Vegas Mixx, the latest club drug being promoted in Las Vegas.  Marketing materials described it as a combination of Valium, to relax the mind, and Viagra, to stimulate the, well, you know. 
Vegas Mixx promised to make users perform “Like a Porn Star.”

I’m no medical expert, but this didn’t sound like a good idea.  Valium, a controlled substance, can have serious side effects.  And Viagra, well, warnings about erections lasting longer than four hours should give anyone pause.  Was it legal?  When I was a reporter at the Las Vegas Sun, the guys running the local compounding pharmacy that made Vegas Mixx had no problem telling me they were just trying to make a buck.  They claimed it was legal.  And indeed, the pharmacy never was disciplined by the Nevada State Board of Pharmacy.  They only stopped producing the drug because it wasn’t profitable.

Vegas Mixx turned out to be a bust.  But it highlighted an evolution in the drug compounding industry, which has come under intense scrutiny after steroids produced by a Massachusetts company were linked to 12 fungal meningitis deaths and 137 infections in 10 states.  The New England Compounding Center, which made the injectable steroids linked to the outbreak, acted more like a drug manufacturer than a traditional compounding pharmacy, said David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacies.

Compounding pharmacies typically provide custom-made drugs based on individual physician prescriptions tailored to specific patients, who, for example, might be allergic to a mass-produced product. In contrast, the compounding pharmacy that made Vegas Mixx was making and marketing a drug combo before a doctor had prescribed it.  The New England Compounding Center shipped more than 17,000 doses of steroid injections to 23 states, according to the Centers for Disease Control.

Those steroid doses, and other concoctions by compounding pharmacies, are exempt from traditional review and approval by the Food and Drug Administration, which is charged with assuring the efficacy, purity and safety of manufactured drug compounds and strict adherence to sanitary manufacturing standards.

An FDA official said in an email that state pharmacy boards are the front lines of enforcing the activities of compounding pharmacies.  The FDA can step in, but there have been conflicting court rulings about how federal law applies to compounding pharmacies, the FDA official said.

That means compounding pharmacies operating as manufacturers are below the radar of FDA oversight, Miller said, potentially putting patients at risk.

This could have been prevented.  More than a decade ago, David Kessler, former FDA commissioner, issued a warning about the future of compounded drugs at a Congressional hearing prior to passage of the Food and Drug Administration Modernization Act of 1997.  He said that ambiguity in the law could allow for “large scale manufacturing under the guise of pharmacy compounding,” leading to a “shadow industry” of unapproved generic drugs.

Provisions in the act designed to clarify FDA oversight of compounding pharmacies — including restrictions on their ability to advertise drugs — were later struck down by courts.  Still, the FDA says it can act in some circumstances, such as when a drug is contaminated or mislabeled.

Miller said he believes only a few rogue compounding pharmacies are operating outside traditional boundaries.  The New England Compounding Center “appears to have been acting as a manufacturer without being registered as a manufacturer with the (Food and Drug Administration), or registering with the Massachusetts Board of Pharmacy as a manufacturer,” he said.

“Something does need to change. That’s something our association is grappling with right now,” he said.  In the wake of the outbreak, officials from the academy are in contact with congressional staffers to discuss how to
increase oversight without stifling traditional pharmacy practices, Miller added.

Other cases have raised alarms.  In 2007, a Portland Tribune investigation revealed patient deaths that were linked to a bad batch of drugs, used to treat back pain, from a Texas compounding pharmacy.  A pharmacist who consults with the advocacy group Public Citizen called the compounding pharmacy industry a “shadow drug industry,” in an interview with the newspaper.  And this week the Tennessee attorney general filed a complaint against HRC Medical Center, a hormone replacement therapy company that used a compounding pharmacy to produce the testosterone pellets for women.

In the past year, I interviewed several women who were treated at HRC facilities, and they complained of testosterone treatments that led to excess facial hair, uncontrollable rage and genital growth.  One doctor who reviewed an HRC patient’s medical records on behalf of ProPublica said her testosterone levels were more than four times normal – into the range of a man. 

It’s unknown whether the alleged problems at HRC Medical were caused by the providers, by the pharmacy, or both.   Officials from HRC Medical did not return calls for comment.  But according to the attorney general’s complaint, the hormone pellets the compounding pharmacy supplied to HRC Medical could trigger an unpredictable release of hormones
in the blood stream due to their unproven method of manufacturing.
The pharmacy’s production standards, material handling practices and
operating procedures were not FDA approved
, the complaint stated.

Miller said responsibility for the fungal meningitis outbreak goes beyond the compounding pharmacy involved and regulatory gaps.  Doctors and medical providers purchased the drugs and should also be held accountable for the patient harm, he said.

“What due diligence did those facilities do to assure the drugs they were purchasing were appropriate, safe and effective?” he asked.

Sagar Atre of ProPublica contributed reporting to this story.

* * * * * * * * *

This is part II of a two-part series on the national meningitis outbreak.  Readers may also want to see the Sentinel’s previous story here:

600 Californians Received Shots Linked to National Meningitis Outbreak: Mendocino County Medical Center on Watch List for Non-FDA Regulated Drug.”

Winner of the Pulitzer Prize in 2010 and 2011, ProPublica is an independent, non-profit newsroom that produces investigative journalism in the public interest, according to their website

Based in Manhattan with a newsroom of 34 working journalists, the organization is dedicated to investigative reporting on stories with “moral force” and a significant potential for major impact.

Images by Humboldt Sentinel
Posted by Skippy Massey

 

One Response to “What a Failed Vegas Sex Pill and The Meningitis Outbreak Have In Common”

Trackbacks/Pingbacks

  1. [...] This is part I of a two-part Sentinel series on the national meningitis outbreak and compounding pharmacies.  Part II: “What a Failed Vegas Sex Pill and the Meningitis Outbreak Have in Common” may surprise you– and  can be found here. [...]


Leave a Reply

HumSentinel on Twitter

RSS Progressive Review

  • Word: Where the Palestinian crisis began
    Donna Nevel, a community psychologist and educator, is a long-time organizer for peace and justice in Palestine/Israel. Most recently, she was a founding member of Jews Say No!, is on the board of Jewish Voice for Peace, and is a member of the coordinating committee of the Nakba Education Project--US.Donna Nevel - As Israeli government violence against the P […]
  • Israel hiring students to troll social media sites
    USA Today - Israel is looking to hire university students to post pro-Israel messages on social media networks — without needing to identify themselves as government-linked, officials said Wednesday.The Israeli prime minister's office said in a statement that students on Israeli university campuses would receive full or partial scholarships to combat an […]
  • The war crimes Israel and Obama are committing
    Shamus Cooke, Anti-War - The two most glaring war crimes Israel is committing – as defined by the Geneva Convention – are the concepts of “collective punishment” and “necessity and proportionality.”Under collective punishment, a warring party cannot respond to an attack by waging war on the attacker’s community, as is clearly happening in Gaza. The clearest […]
  • California drought update
    LA Times -Te groundwater level in the San Bernardino Basin area is at its lowest point in recorded history, officials say.hMeasured in volume, the groundwater level for the basin is now about 500,000 acre-feet below full, according to Douglas Headrick, general manager for the San Bernardino Valley Municipal Water District.That would put it below the previous […]
  • CORECTION: Mandela on Palestine
    The letter we posted a few minutes ago allegedly from Mandela to Thomas Friedman was actually a satirical piece. According to The Electronic Intifada, this article was written by Arjan El Fassed in 2001 in the satirical style then being employed by Thomas Friedman, of writing mock letters from one world leader to another. Although it carries El Fassed’s byli […]
  • Jazz break
    MONTY ALEXANDER: SATIN DOLL […]
  • Senior news and links
    Senior news Medicare Social Security   ESSAYS No retirement age for rebellion Thoughts on old age The real problem with Social Security Word: Social Security Why Social Security and Medicare are not going bankrupt Social Security is massive anti-poverty program […]
  • Massive retaliation reported in Veterans Administration
    Lydia Dennett, Project on Government Oversight - In California, a Department of Veterans Affairs inpatient pharmacy supervisor was placed on administrative leave and ordered not to speak out after protesting what he described as errors and delays in the delivery of medications to patients.In Pennsylvania, a former VA doctor was removed from clinical work and […]
  • Top foreign aid recipients per capita
    VOX […]
  • How Israel helped to create Hamas
    Richard Sale, UPI, June 18, 2002 - Israel and Hamas may currently be locked in deadly combat, but, according to several current and former U.S. intelligence officials, beginning in the late 1970s, Tel Aviv gave direct and indirect financial aid to Hamas over a period of years.Israel "aided Hamas directly -- the Israelis wanted to use it as a counterbala […]
  • Warmest June on record
    Rural Blog - The earth continues to experience record-breaking temperatures. Last month was the hottest June on record, following a trend in which the previous month was the hottest May on record, according to a report from the National Oceanic and Atmospheric Administration."Primarily, it was the oceans of the world that pushed the mercury into the red […]
  • Book: Israel tried to blackmail Clinton over Lewinsky
    As noted below, we reported a NY Post account of this 15 years ago.Daily Mail, UK -  According to a new book, tapes of Bill Clinton’s steamy phone sex with Monica Lewinsky posed a threat to national security and resulted in a not-so-subtle ‘blackmail’ attempt by the Prime Minister of Israel, who used the torrid exchanges to try to ‘convince’ the President to […]
  • Stupid Florida tricks
    WFTV, Fl - Pull up or pay up: It's now illegal to wear low pants that expose underwear or bare buttocks in parts of Ocala.Th City Council voted unanimously Tuesday to approve an ordinance that prohibits anyone on city property from wearing pants 2 inches below their natural waist."I just think it's disgraceful to show your underwear," Cou […]
  • Police blotter
    Baltimore Sun - Johns Hopkins Hospital has agreed to pay $190 million to settle claims from thousands of women who may have been surreptitiously recorded during pelvic exams by gynecologist Dr. Nikita A. Levy.The amount of the settlement is one of the largest on record involving sexual misconduct by a physician. Levy, a doctor in the Johns Hopkins Community […]
  • Obamacare in big trouble
    Kaiser Health News - In what could be a major blow to the Affordable Care Act, a three-judge panel for the U.S. Court of Appeals in Washington ruled Tuesday that subsidies may not be offered in the federal health exchange. The decision overturned a lower court ruling. You can read the decision here.The Washington Post: Federal Appeals Court Panel Deals Major […]