Walmart, in one of their worst ways of prioritizing prices above qualities to date, turns to a foreign drug supplier, Ranbaxy Laboratories, LTD, who has repeatedly been investigated by the FDA and the DoJ for “inadequate” safeguards against contamination, falsification of records and submitting false information to the FDA.  

On top of that, just eight months before the FDA inspected Ranbaxy’s Paonta Sahib plant and found significant violations, Walmart awarded the company a “Supplier Award” for improving shipping times and performance.

In a new report on our website, we detail their multi-year spanning violations, DoJ investigation, Congressional Investigation, and list out all of the drugs made at the facility in questions.  Additionally, we detail their recent violations below.  

2009 Violations

In Feb 2009, the FDA halted a review of importation applications for generic drugs manufactured at Ranbaxy’s Paonta Sahib plant owned by Ranbaxy Laboratories, LTD, the Indian generic drug manufacturer, “due to evidence of falsified data.” According to the FDA press release, Ranbaxy “falsified data and test results in approved and pending drug applications.” Not only were seven different examples of false statements made by Ranbaxy to the FDA in their warning letter – this was the third time the facility had run afould of fed Food and Drug laws.  

The FDA did include a caveat in its release, stating that the agency “has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.”  But just a week after the FDA announced it was halting review of Paonta Sahib applications, Canada announced it was “quarantining” all drugs produced at the Paonta Sahib plant.

2008 Violations

Previously, in September 2008, the FDA issued warning letters to Ranbaxy regarding “significant deviations” from FDA standards for the manufacture of drugs sold in the United States. According to an FDA press release, the agency also banned the importation of any Ranbaxy drugs produced at the company’s Dewas and Paonta Sahib plants.

According to the release, the Dewas plant’s cross-contamination prevention program was “insufficient.” These programs are designed to prevent cross-contamination between different types of drugs. The plant also used “inadequate” sterilization procedures and performed “inadequate failure investigations.” According to the FDA release, failure investigations are performed “to address any manufacturing control or product rejection to determine the root cause and prevent recurrence.” The Paonta Sahib plant had “inaccurate” records regarding cleaning and maintaining of its equipment and “incomplete” records.

Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, announced that the “severe violations” had led the FDA to ban importation of drugs from these plants and to deny any new drug import applications for drugs manufactured at these plants.

Before the warning letters were sent and the sanctions put in place, Ranbaxy had the opportunity to rectify the problems at the Dewas and Paonta Sahib plants; however, the company’s “response failed to adequately address multiple, serious deficiencies.”

Again – please read our full report at Wake-Up Wal-Mart.

With most observers assuming that Senate President Pro Tem Peter Shumlin will join Senators Doug Racine, Susan Bartlett and (unofficially as yet) Secretary of State Deb Markowitz in the running for the Democratic gubernatorial nomination, Racine continues his strategic campaigning (campaign staffer Mark Larson’s impact, perhaps?). His first big move was to start openly building bridges with Progressives, keeping Markowitz from owning the “electability” meme by framing it on finances alone. Now, with the goodwill and support among the GLBT community accumulated by Shumlin with his leading role on marriage equality and his recent boycott of a DNC fundraiser as an act of solidarity with gay and lesbian activists slighted by the Obama administration, Racine is moving to shore up his own bona fides among this important voting bloc. From a press release:

In an open letter to gay, lesbian, bisexual and transgender Vermonters and their allies State Representatives Bill Lippert, Suzi Wizowaty and Steve Howard announced their decision to support Sen. Doug Racine in the 2010 Governor’s race today.

“As legislators, and members of Vermont’s gay, lesbian, bisexual and transgender community, we appreciate Doug’s leadership on issues that affect all Vermont families, including our families,” said Rep. Wizowaty…

…In their letter, the three legislators recount then Lieutenant Governor Racine’s early support for marriage equality.  In 1999, Hawaii had just overturned its decision on marriage, Vermont was still awaiting a decision in Baker v. State, and a mailing signed by Hawaiian legislators warning against marriage equality had just been sent to every Vermont home.  A scathing Free Press editorial at the time accused Lt. Governor Racine of being irresponsible and inviting “warfare within Vermont’s borders and unprecedented assault from without.”  

“In the face of this political risk, almost every major Vermont political leader remained silent.  Doug, however, publicly declared his belief that our families should be treated equally under the law,” states the letter from the legislators.

Hmm. “Almost every Vermont political leader.” A little poke at Racine’s rivals? Careful, folks.

Howard also gives Racine an early endorsement in Rutland County, providing a beachhead for more buzz outside his home region. Complete release is below the fold.

State Representatives Bill Lippert, Suzi Wizowaty and Steve Howard announce support for Doug Racine for Governor.

Tuesday June 30, 2009 Burlington VT:  

In an open letter to gay, lesbian, bisexual and transgender Vermonters and their allies State Representatives Bill Lippert, Suzi Wizowaty and Steve Howard announced their decision to support Sen. Doug Racine in the 2010 Governor’s race today.

“As legislators, and members of Vermont’s gay, lesbian, bisexual and transgender community, we appreciate Doug’s leadership on issues that affect all Vermont families, including our families,” said Rep. Wizowaty.  “We need a governor who can bring Vermonters together to solve the real challenges facing our state.  Doug Racine is the person who can best do this.”

In their letter, the three legislators recount then Lieutenant Governor Racine’s early support for marriage equality.  In 1999, Hawaii had just overturned its decision on marriage, Vermont was still awaiting a decision in Baker v. State, and a mailing signed by Hawaiian legislators warning against marriage equality had just been sent to every Vermont home.  A scathing Free Press editorial at the time accused Lt. Governor Racine of being irresponsible and inviting “warfare within Vermont’s borders and unprecedented assault from without.”

“In the face of this political risk, almost every major Vermont political leader remained silent.  Doug, however, publicly declared his belief that our families should be treated equally under the law,” states the letter from the legislators.  “For doing so, he was resoundingly criticized by many.  We know that his critics were wrong, but we remember Doug’s courage in standing up for our rights.  When we needed Doug, he stood by us and our families.  And we are proud to now stand by him.”

“Doug’s leadership on our civil rights has been strong and longstanding.” said Rep. Lippert.  “As a member of House Judiciary Committee, and for many years the only out legislator, I know how important reliable allies have been to the fight for our civil rights.  From adoption rights to marriage equality, Doug has always been with us.  His leadership and commitment to our rights have made a real difference for our community.”

The three legislators made it clear though that their support was not just about Sen. Racine’s record of civil rights.  “While much appreciated, my support is not just because of Doug’s support for our community,” stated Rep. Howard.  “Doug understands the challenges of working Vermonters and gets the importance of re-building a strong economy.  We need better jobs.  Promises aren’t enough.  All Vermonters will benefit from the new style of leadership that Doug will bring to the Governor’s office.”

Rep. Bill Lippert represents Hinesburg and is the Chair of the House Judiciary Committee.  Rep. Steve Howard represents Rutland City and serves on the House Ways and Means Committee.  Rep. Howard is also a former Chair of the State Democratic Party.  Rep. Suzi Wizowaty represents the south end of Burlington and is on the House Health Care Committee.

For more information contact Mark Larson at mark.larson@dougracine.com or 355-4507.

Correction: Harlan Sylvester did not sponsor the fundraiser for Salmon, as was reported to me. Shoulda confirmed that before posting. My bad. -odum

Remember during the height of the budget conflict between the Legislature and the Governor when Auditor Tom Salmon Jr. attempted an ill-advised grandstanding stunt by inserting himself (rather inartfully) into the process? Salmon offered himself as mediator (having, of course, no qualifcations to serve in that capacity and stepping far beyond his purview as State Auditor) in the midst of a debate that legislative Dems were managing quite well without him. By trying to play the role of wise father figure and casting the debating parties as self-interested partisans who needed to compromise further than the Dems already had, Salmon played into the hands of Governor Douglas, who tried (and failed, thankfully) to use Salmon’s play to his own advantage.

Well, as with the repetition of his casinos-on-the-ski-areas notion, Salmon seems recklessly oblivious to bad buzz, and is at it again. Last week he sent an email to Senator Shumlin, Speaker Smith, Secretary of Administration Neale Lunderville and Douglas Chief of Staff Tim Hayward trying to shove his way into the Joint Fiscal Office’s process of identifying cost savings by suggesting he might be cheaper than the consultants budgeted into the process. In the email, he reportedly demands to know what the status of the process is, as well as any so-dubbed bi-partisan crisis planning (?) underway.

O-kay. A politician with clear and rather blunt political ambition would be a better arbiter than neutral professionals with hands on experience in such matters. Frankly, I’m finding myself a bit concerned about Salmon’s perspective on reality.

After all, it was only last week that he indicated to Totten that he wanted to run for Governor in 2012. I suppose he’s not planning on being too helpful in putting a fellow Democrat into the office over Douglas next year?

So this guy, whose here-I-come-to-save-the-day schtick has already worked against his party’s legislative leadership this year, whose stated ambitions imply he might be less than enthusiastic supporting their electoral interests (as in, getting a Dem Governor) next year, and who has stated his intention to run against the current Governor next cycle… this guy is supposed to be taken seriously by all parties as a mediator or arbiter (or is it manager?) of this process? Is he nuts?

Or if not nuts, maybe just smug. Last week he had a fundraiser held for him by that reportedly included financier Harlan Sylvester – he of Democratic boogeyman fame. Sylvester is the conservative, so-called “Democratic” moneyman who was a supporter of Howard Dean, but dumped the Dems for Jim Douglas rather than back Doug Racine in 2002, who he saw as too liberal. Perhaps Salmon has decided that he’s been knighted by Sylvester, so everything else is just a formality? If so, he is – like so many others – comically overestimating Sylvester’s impact. We do still have quaint little things called elections.

Speaking of which, Salmon might want to bear something in mind; it’s only summer of 2009. There’s still plenty of time for a primary challenge this cycle to emerge.

This past month almost at the same moment the media stared with awe at the capacity of twitter to cover the Iranian election protests and broadcast their cause worldwide against the wishes of the hard-line government, another story has played out nearby and to a large degree behind the scenes. In the middle of June after seven months of captivity New York Times reporter David Rohde and an a translator Tahir Ludin escaped from their Afghan Taliban kidnappers by scaling down wall and miraculously walking to safety at a checkpoint .The fact that they were kidnapped and held was kept under near total news blackout with the cooperation of most of the media as we know it. With one of their  collogues life was at stake a black-out on news regarding the event was seen as  a way to keep the situation from escalating and further endangering the reporter and his translator. “Persuading another publication or a broadcaster not to report the kidnapping usually meant just a phone call from one editor to another,” said Bill Keller, executive editor of the Times.

It is amazing yet not unexpected what the New York Times in a life or death situation can accomplish with a phone call. However the next step getting the blackout to extend to Wikipedia has set an interesting precedent in its own way. Think about the fact that with all the Google ,the inner tubes, wiki’s and the tweeters  a major news story was still successfully blacked out for over half a year .Separate out the purity of motive  for a minute and consider the  ability that a small group of people can have over information distribution in the world, even today with the media fractured in thousands of little pieces. .

To a degree this brings down to Earth some of the rhetoric about the power the internet gives to the huddled masses. Google at will can still clamp down information in China and with a call from Bill Keller the New York Times can, in a pinch easily stop and alter Wikipedia entries as it needs. Just as in Iran the U.S. State Dept requested multiple social networking and communication services to keep information flowing, it might have in another situation worked to shut them down.

The sanitizing was a team effort, led by Jimmy Wales, co-founder of Wikipedia, along with Wikipedia administrators and people at The Times. In an interview, Mr. Wales said that Wikipedia’s cooperation was not a given.

On Nov. 13, news of the kidnapping was posted and deleted four times within four hours, before an administrator blocked any more changes for three days. On Nov. 16, it was blocked again, for two weeks.

“We didn’t want it to look unusual in some fashion that would draw speculation, so we would protect it for three days, or up to a month, which is pretty normal,” Mr. Wales said. He added, “Weeks would go by before there was a problem.”

On Feb. 10 and 11, two users added the kidnapping information several times to Mr. Rohde’s page, only to see it removed each time, and they attached some heated notes to their additions. “We can do this months,” one said.

When the news broke Saturday, the user from Florida reposted the information, with a note to administrators that said: “Is that enough proof for you [expletives]? I was right. You were WRONG.”

http://www.nytimes.com/2009/06…

http://www.editorandpublisher….

From today’s Brattleboro Reformer, in a piece by By Howard Weiss-Tisman:

Vermont… has not yet sent in its application to the U.S. Department of Education for its share of stimulus money.

States have until July 1 and Vermont expects to receive $77 million from the State Fiscal Stabilization Fund…

Vermont’s application was held up due to the budget fight between Gov. James Douglas and the Legislature, and Tom Evslin, the state’s chief recovery officer, said his staff is working to get the application in on time.

“We could not finish this until the budget was finalized. We could not have done this any sooner,” Evslin said Monday.

So let me get this right: the governor’s pissing match with the legislature had the potential to completely eliminate our deadline for the Fiscal Stabilization money?

Maybe he just likes to play chicken.

I honestly don't remember what I was doing forty years ago today, and I don't remember anything about this until I read about it later in the Voice. Still, as we look back, it's clear that the Stonewall riots were, in their own way, as significant as Rosa Parks refusing to get off the bus.

It's worth watching this video of people who were there.

Lazy reporting by the Burlington Free Press today on the issue of guns.

Front page, above the fold: 

Gun, ammo sales soar

Vermont follows national trend; buyers fear stricter laws

  What follows is almost five hundred words, plus pictures and graphics, on the apparent boom in sales of guns and ammunition, all starting “Soon after President Barack Obama was sworn into office”, and supported by interviews of gun selers and buyers, statistics, and this juicy quote:

 “Basically, they’re afraid of the Obama Administration coming up with stricter laws,” Jim Datillio, owner of Dattilio’s Discount Guns in South Burlington, said of his customers.

What's missing? How about any discussion of what Obama has said, either during his campaign or since he took office, about what he proposes to do about guns?

How about any discussion of how the NRA and other right-wing organizations have been pounding the “Obama's gonna take your guns” drum ever since he started running, and have never stopped?

I guess analysis and reality-based reporting would be too challenging for them. Maybe they figure it's “fair and balanced” to report on the myth that Obama is about to take people's guns away, but it would be biased to correct the myth.

I've subscribed to a daily newspaper my entire adult life, but the Free Press doesn't make it easy.

UPDATED: Vermont Newsguy also covers this here.

I’m really not sure the best way to meaningfully, constructively and effectively deal with this – but we’d better figure out something.

Required viewing from Rachel Maddow:

Here’s something else to look for on the July campaign finance filings under “consulting.”

Democratic Rep. Megan Smith, whose district spans Bridgewater, Chittenden, Killington, Mendon, is the subject of robocalls into her towns attacking her votes on taxes, the state budget, and lifting Pre-K caps (pesky kids).

Interestingly, the calls show up on caller ID as from a number in the Washington DC area: 202-747-7306. There is no answer when the number is called back. Not only has the phone number been associated on the web with calls against a Democratic-Party-associated judge in Pennsylvania, as well as in support of former Republican US Representative Melissa Hart, also from PA (h/t/ Barlow).

But sharp-eyed readers will recognize it as the phone number behind some of the anti-marriage equality robocalls in Vermont earlier this year.

So the question then is, why? The timing doesn’t seem very useful. It is rather a long time between now and election day, and robocalls are getting to be a touchy subject among many in Vermont and are generally being approached with more care of late, rather than less.

The possibilities that jump to mind are that its a) message testing against a “live” target, or b) something funded by the local-level GOP. Robocalls are amazingly cheap, so it wouldn’t take much fundraising to make it happen (and local organizations can be a little more impulsive than their larger-scale, professionally staffed counterparts). If so, given that these calls apparently represent a go-to firm for state Republicans, its likely being at least coordinated at the State Committee level through our pal Rob Roper.

The question is, then, are these calls happening in any other districts against any other incumbent Dems (or Progs, for that matter). Anybody hear anything? Better yet, anybody record anything?