Sunday, July 28, 2013

Sunday Globe Special: Quorum Conundrum

What do I add?

"Failure to get quorum didn’t stop Mass. panels; 7 agency licensing boards have record of taking votes anyway" by Todd Wallack |  Globe Staff, July 28, 2013

There was one glaring problem when a state board overseeing nursing home managers met in a fourth-floor conference room near TD Garden on Jan. 17: Not enough people showed up.

Only six members attended the meeting — two short of the quorum needed to legally conduct business — and one of the six left after 22 minutes.

But members and staffers didn’t seem to notice. The Board of Registration in Nursing Home Administrators proceeded to vote on more than a dozen items, including denying a Braintree consultant’s request to teach seminars for nursing home managers who are required to take continuing education courses to maintain their licenses.

“I am upset that action was taken inappropriately,” said Sean Dore, president of Z.S. Consulting Group and a former state public health official, who said he complained to the agency after the Globe asked him about the vote. He said the rejection potentially cost him income. “The law is black and white.”

One of the most basic rules of serving on a government board is that you can’t have an official meeting unless you round up enough members for a quorum — typically a majority of all the seats on the board.

But all too frequently, professional licensing boards overseen by the Massachusetts Department of Public Health have defied the rules.

Those rules are only for other people. 

Since when did or has government had to follow its own laws and rules?

A Globe review of meeting minutes found that seven of the boards, regulating everything from pharmacists to genetic counselors, have collectively held more than a dozen meetings without a quorum in the past five years, throwing any votes taken on those days into doubt....

Though there’s no law barring a small group of board members from meeting informally and even taking straw votes on issues, it’s not considered an official meeting and the votes don’t legally count, attorneys said....

Both state Senate minority leader Bruce Tarr, a Gloucester Republican, and state Senator Mark Montigny said they were disturbed to learn the health-related licensing boards were violating quorum rules, since it puts their actions in doubt. Meeting minutes show the boards voted on scores of items — from changes in regulations to disciplinary actions — without enough members present.

Actions are quite clear to me: it's a dictatorship.

“It’s outrageous and it needs to cease immediately,” said Montigny, a New Bedford Democrat. “You don’t get to flout the law on a whim.”

You do in Massachusetts if you are in state government. Where you been living, fella?

Montigny noted that the invalid votes open up the boards to potential lawsuits, both from people dissatisfied by the votes or from any third parties who are harmed by the decisions. It also creates the risk that the boards made the wrong decisions because missing members weren’t present to raise questions or provide insights that could affect the outcome.

Uh-oh, taxpayers.

“It’s an accident waiting to happen, and, at this agency, we’ve already had a lot of accidents,” Montigny said.

Public health officials acknowledged Friday that several of the licensing boards — including those overseeing pharmacists and physician assistants — clearly violated the quorum rules. The state vowed to implement new training to make sure the panels comply with the law in the future....

Then they start parsing the law.

Department of Public Health spokesman David Kibbe said the Department of Public Health will follow the attorney general’s guidance going forward, but it still believes its old interpretation was valid for past meetings....

Even when they are wrong and break the rules or law, they are right and didn't break the rules or law. 

And they wonder why we don't believe a damn word that comes out of their mouths anymore?

Leonard Kesten, a trial lawyer who represents cities and towns, including their boards and employees, however, said it would probably take an aggrieved party, such as someone who was punished, to challenge the actions in court. And the boards could likely solve the problems by voting on the items again at a proper meeting with a quorum, Kesten said.

Meanwhile, at least a half-dozen people have filed complaints with the attorney general about municipal board meetings that were held without a quorum in the past two years. But the attorney general’s office has typically declined to act on such complaints, arguing that is outside the purview of the Open Meeting Law because the statute only covers meetings with a quorum.

Not all meetings are open.

Related: Mass. Legislature Exempts Itself From Ethics Reform 

The Perils of One-Party Politics: Massachusetts' Democracy 

Kind of hits you like a bolt of lightning, 'eh?

Nevertheless, Brad Puffer, a spokesman for the attorney general, noted: “It is always in a public body’s best interest to follow the rules.”

You would think, but.... (sigh).

The head of an organization representing municipal attorneys said he thought quorum violations were relatively rare for cities and towns. He said most local officials have long understood that boards need a majority of positions to vote....

“I would think instances where a local board did not understand the law would be far and few between,” said James Lampke, executive director of the Massachusetts Municipal Lawyers Association.

He got that backwards. Freudian slip? Means most don't understand the law (not surprised), and it happens a lot (wouldn't doubt it).

But Lampke said occasional errors are inevitable in government.

“It’s public service,” Lampke said. “It’s not perfect service.”

I'm wonder what they get for the service of $itting on the board.

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The revelation about the quorum-short meetings comes at a time when the Department of Public Health has already been blamed for two major scandals in which lax management was a key issue.

The agency’s drug lab was shuttered last year after disclosures that state chemist Annie Dookhan may have falsified thousands of drug tests in criminal cases over several years. And the pharmacy board’s executive director was fired for allegedly failing to act on a complaint about a Framingham compounding pharmacy before its products were linked to 61 deaths....

Oh, I see six souls or so have been added to the death list since we last looked.

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FLASHBACKS:

Slow Saturday Special: FDA Finds More Problems at Compounding

"State board gave reprieve to Webster pharmacy; Teen had suffered heart attack after taking medication" by Todd Wallack |  Globe Staff, July 09, 2013

Just months before a meningitis outbreak exposed major holes in the state’s oversight of pharmacies, regulators abandoned a plan to shut down a Massachusetts pharmacy whose medication error sent a teenager to the emergency room with a heart attack. They have yet to discipline the company for the mistake.

This compounding scandal is the one that really showed me the power of the prescription pharmaceutical lobby in this country. It's often a $ilent lobby (Israel and other corporate interests draw much more attention), but it has become one of the most powerful.

State records obtained by the Globe show that in July 2011, Royal Palm Specialty Pharmacy of Webster accidentally gave a boy thyroid medication that was 1,000 times too strong, requiring him to be hospitalized with serious heart problems. The board found out about the incident only when the boy’s mother complained four months later, even though pharmacies are required to promptly report serious errors.

But, after initially voting to shut down Royal Palm last July, members of the Massachusetts Board of Registration in Pharmacy reversed themselves a week later and decided to negotiate a settlement with the company instead, the records show.

What pre$$ure was brought to bear?

A year later, the board has yet to reach an agreement with the company or discipline the pharmacy. And Royal Palm has continued to operate with few restrictions, though the company has acknowledged the mistake to regulators and promised to take steps to prevent similar accidents in the future.

“This speaks to a systemic problem” with state regulators, said Sarah Sellers, a former Food and Drug Administration official who advocates more stringent regulation of compounding pharmacies, which make specialized versions of drugs that aren’t readily available from major drug manufacturers. “The states are not doing enough to identify the problems, figure out the scope of the problems, and correct the problems.”

The state pharmacy board already has come under fire for ignoring warning signs about another compounding pharmacy, New England Compounding Center, whose injections were linked last fall to an outbreak of fungal meningitis that killed 61 people and sickened 749 in 20 states. The Framingham-based company which, like Royal Palm, made specially formulated drugs, later surrendered its license.

Since then, Governor Deval Patrick has vowed to make sure nothing like the meningitis outbreak ever happens again....

Either way, this IS CRIMINAL, right? I mean, PEOPLE DIED suffering horrendous pain!

Massachusetts officials also insisted they are still pursuing potential disciplinary action against Royal Palm, cautioning that it takes time to complete a thorough investigation....

They sound like the FBI now.

In most cases, compounding pharmacies are small mom-and-pop operations, but as the industry grew....

It's been taken over by global pharmaceutical firms.

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And as I sit here today, nothing has really changed. That's the way it is with so many important issues in the $tatus quo paper. The only things that do change are those that further advance the agenda.

UPDATE: 

"Thousands of Massachusetts residents who have health insurance through Harvard Pilgrim Health Care are learning that the company will no longer cover specialty medications known as compounded drugs, because of safety and cost concerns, a decision that has infuriated pharmacists and worried patient advocates. The action follows last year’s deadly fungal meningitis outbreak linked to a Massachusetts compounding pharmacy. Dr. Michael Sherman, Harvard Pilgrim’s chief medical officer, said the insurer’s new policy stems from its safety review after the meningitis outbreak. More than 700 people were sickened and 58 died as a result of taking tainted steroids produced at New England Compounding Center in Framingham." 

Add three more souls to the death list in the interim.

Also see:

Citing backlog, state health agency pleads for funds
Bill aims to increase pharmacy oversight in Mass.
Lawmakers should go farther on compounded-drug safety

You know who can fix this?

"Senate bill puts compounding pharmacies under FDA rule" April 27, 2013

WASHINGTON — Large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards under a Senate proposal introduced Friday.

The draft bill is the first Senate effort to address the recent outbreak tied to contaminated compounded drugs that sickened more than 700 Americans and killed more than 50 others. The wave of deadly fungal infections was linked to New England Compounding Center, a Framingham pharmacy that regulators said was operating more like a manufacturer.

The proposal would subject such large compounding operations to direct federal oversight by the Food and Drug Administration, rather than state pharmacy boards that have traditionally overseen the space.

Compounding pharmacies mix customized solutions, creams, and other medications in doses specified by a doctor’s prescription. Over the last two decades though, larger compounding operations have emerged that produce medications in bulk and ship them across state lines....

Last week, FDA Commissioner Margaret Hamburg said her agency was not aggressive enough in policing the company because of the conflicting patchwork of state and federal laws that govern pharmacies. The Senate bill is designed to clear up that ambiguity....

The bill was drafted with support from Republicans....

Traditional compounding pharmacies will continue to be regulated by state pharmacy boards. However the bill identifies ‘‘compounding manufacturers’’ as pharmacies that produce injectable drugs and ship them across state lines without patient-specific prescriptions from doctors. These operations will have to register with the FDA, report the drugs they make, and meet standards similar to those required of drug manufacturers.

As the first bipartisan bill in Congress aimed at addressing last year’s outbreak, the Senate legislation has the best chance of becoming law, observers say. Several Democrats in the House of Representatives have introduced similar measures, but Republicans who control that chamber have showed little interest in passing compounding legislation.

Previous congressional efforts to regulate the space have been scuttled before, stretching back to the 1990s.

In the last attempt, in 2007, the legislation was abandoned after compounding pharmacists waged a grass-roots campaign against it, visiting Capitol Hill and lobbying in Senate offices.

The industry’s main trade group, the International Academy of Compounding Pharmacists, spent about $1 million lobbying Congress in the last decade, according to the Center for Responsive Politics.

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Yeah, you might want to test for that $tuff instead:

"More signs of disarray in closed state drug lab" by Scott Allen and Andrea Estes  |  Globe Staff, April 02, 2013

State investigators have found at least a half-dozen drug samples scattered about the state lab in Jamaica Plain, documents show, raising questions about the integrity of all testing where indicted state chemist Annie Dookhan worked.

Thought that was/is kind of important.

Investigators for the state ­inspector general, who have been combing through the closed lab for months, found a plastic bag containing “a white rock substance” and test tubes “containing unknown substances” in one supervisor’s ­office. They found pills taped to a lab bench cabinet and old samples, including marijuana submitted in 1996.

Related(?): Drug Addict Worked at State Drug Lab

Oh, that's rich!

The findings, in a confidential report by the attorney ­general, add fuel to defense lawyers’ arguments that virtually all drug tests done there since 2003 are suspect, expanding the number of cases that could be affected by the scandal from the 34,000 handled by Dookhan to the 190,000 cases processed by the entire lab.

Thought that was/is kind of important.

A leading authority on crime labs said that failing to secure and track all evidence is a fundamental failure in a crime lab....

Thought that was/is kind of important.

Unlike hundreds of other crime labs nationwide, including the Boston police crime lab, the Massachusetts lab was not ­accredited....

Are you f***ing s***ting me?

Matthew Segal of the American Civil Liberties Union of Massachusetts said the illegal drugs found lying about the lab reflects labwide problems that undermine the credibility of all drug testing there....

Thought that was/is kind of important. 

Hey, government is ONE LONG PARTY these days, or haven't you heard?!

But prosecutors said they believe the inspector general’s discoveries will not jeopardize cases handled by other chemists in the lab.

They can't be serious. 

“People at my office aren’t overly alarmed,” said Norfolk District Attorney Michael W. Morrissey. “We can’t point to any cases that were directly ­affected. You’re trying to find out if the other shoe is going to drop. That’s everyone’s question. What they did or didn’t do. How bad is the problem? We’ll have to wait for the result of the forensic investigation.”

Jake Wark, spokesman for Suffolk District Attorney Daniel F. Conley, said that the samples that were discovered may have no bearing on cases that were actually tried. “They could be linked to closed cases or no ­cases at all,” he said.

Doesn't matter. Anything that came out of that lab is tainted "evidence" now. 

Have you ever noticed that prosecuting authorities in the U.S. rarely, if ever, admit a mistake.

Never heard back on the fires, either. I rest my case.

Inspector General Glenn A. Cunha sent investigators to the drug lab in January and February as part of a sweeping investigation of the lab’s practices that is not expected to be completed until later this year. While Attorney General Martha Coakley is handling the criminal investigation, Cunha is looking at the lab’s procedures and whether problems extend beyond Annie Dookhan.

The investigators’ visits, ­described in memos written by State Police officials who accom­panied them, found the lab exactly as workers left it on the evening of Aug. 29. The next morning, State Police closed the lab and did not allow employees back in.

The field reports contain little analysis, and it is clear, in some instances, that investigators did not know exactly what they found....

The union that represents the 11 chemists in the lab, out on paid leave since the lab was closed, defended their expertise and said they are eager to ­return to work.

Wow.

“Make no mistake, these people want to get back to work, preferably with the State Police crime lab,“ said Joe Dorant, president of the Massachusetts Organization of State Engineers and Scientists.

Dorant would not comment on the inspector general’s ­reports.

But defense lawyer ­Michael Tumposky said the ­inspector general’s discoveries should bolster the motion he filed for a new trial in a case that involved a chemist other than Dookhan at the Hinton lab.

“Who are the adults at this lab or was it a case of the ­inmates running the asylum?” said Tumposky. “You know there’s a problem when the guy who is supposed to be in charge has a bag of crack on his desk for no apparent reason.”

Anybody find a pipe?

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Related:

Dookhan the Deceiver

Looks like she not the only one.

"Federal judge rejects convicted drug dealers’ ‘Annie Dookhan defense’" by Travis Andersen |  Globe Staff, May 10, 2013

A federal judge in Boston has denied a motion from two men to withdraw their guilty pleas in a drug case tied to former state chemist Annie Dookhan, the first rejection of a so-called “Dookhan defense” in US District Court in the Hub, according to records and authorities.

In a ruling issued Wednesday, Judge Richard G. Stearns wrote that the two Boston men, Larry Wilkins and Ronald Merritt, admitted to their roles in the sale of crack cocaine to an undercover Boston police officer in April 2011.

Stearns said that Dookhan, who is charged with mishandling and falsifying suspected drug samples at the now-shuttered Hinton lab in Jamaica Plain, tested some of the drugs in the case involving Wilkins and Merritt.

But, the judge wrote, a retest of more samples after the men filed their motions came back positive for cocaine base.

You can't trust that retest!

He said that he “does not dismiss” claims from defense counsel that they would not have advised their clients to plead guilty if they knew the extent of Dookhan’s alleged wrongdoing at the time.

However, “the court does not believe that there is a reasonable probability that either defendant would have foregone a guilty plea [whatever counsel’s advice] and taken his chances before a jury in light of the strength of the government’s evidence,” Stearns wrote.

“Dookhan’s mishandling of drug tests in other cases did not impugn the factual basis that supported the court’s acceptance of the guilty pleas.”

What is this judge smoking?

Robert S. Sinsheimer, a lawyer for Merritt, said Thursday that he had “great respect” for Stearns’s consideration of the case but pledged to appeal his ruling.

“I take Dookhan’s corruption personally,” Sinsheimer said.

“I feel I was duped by a pathological liar. My client, Mr. Merritt, has limited education, and he relied on me to give him honest advice.” he added. “How can I do that when I was not given honest facts?”

I get that feeling every day after I purchase and read a Globe.

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Also seeStaying of jail terms upheld by Mass. SJC

Remember kids, drugs are bad, m'kay?