Thursday, February 6, 2014

Drug Wars

Little different than the war on drugs, that war is on people who have a "problem" with drugs -  they use them. Well again the problem is not that they use drugs it is just the ones that are illegal. As already over talked with regard to Phillip Seymour Hoffman, New York is suddenly or coincidentally raiding not just on a house of heroin but on an actual Doctor's clinic that prescribes meds, not there is anything wrong with that but in this case just a few too many.

This was in today's Times with regards to a new kind of trafficking where the dealers were Doctors. Gee first do no harm or is this more, pass go collect $300 dollars and a scrip? I had no idea that pushers now wore white coats unless they were fur. Well times change.

Doctors Charged in Drug Scheme at Clinic Controlled by Traffickers, Authorities Say
FEB. 5, 2014

It is not an uncommon scene: a waiting room filled with patients hoping to see a doctor. But the crowd of up to 100 people that gathered each day outside the Astramed clinic at 1228 Southern Boulevard in the Bronx, clamoring to get a prescription for the painkiller oxycodone, was a different story, the authorities say.
The clinic was controlled by drug traffickers, and the patients, doctors, prescriptions — and even urine samples — were part of a vast and elaborate scheme to divert oxycodone for sale on the street, the authorities said on Wednesday.

A federal indictment charges that in the operation, corrupt doctors were paid $300 in cash for fraudulent medical visits that lasted a minute or two, involved no physical examination and consistently led to the writing of prescriptions for large doses of oxycodone.

Over three years, Astramed doctors wrote about 31,500 medically unnecessary prescriptions for oxycodone, encompassing about 5.5 million oxycodone tablets with a street value of up to $550 million, a government court filing says.

“The world of prescription drug trafficking is looking more and more like the world of old-school trafficking in narcotics like heroin, cocaine and crack,” said Preet Bharara, the United States attorney in Manhattan, who added that more people have been dying from prescription drug abuse than heroin and cocaine combined.

Federal prosecutors also say that members of the oxycodone ring used threats, intimidation and violence to protect their access to the clinic and its doctors, and had armed bodyguards who remained near the clinic.
Oxycodone is a highly addictive, narcotic-strength painkiller, and its prescriptions have enormous cash value to drug dealers, the indictment says. A 30-milligram tablet has a street value of $30 to $40 in New York City, and a value as high as $100 per tablet elsewhere in the country, the indictment adds. It says a single prescription for 180 of those tablets can net a distributor as much as $18,000 in cash.

James J. Hunt, who heads the New York office of the Drug Enforcement Administration, said the arrests were part of dismantling “the largest pill mill in the Northeast.”

Mr. Bharara announced the federal charges with Bridget G. Brennan, the special narcotics prosecutor for the city; William J. Bratton, the police commissioner; and Mr. Hunt. The investigation involved the use of at least a dozen cooperating sources, confidential informers and undercover agents, prosecutors said.

The federal indictment charges Dr. Kevin Lowe, the owner of the clinic and others in the city, and 23 other people in connection with the scheme. Dr. Lowe alone collected nearly $12 million in fees over three years in the scheme, prosecutors said.

Dr. Lowe, who pleaded not guilty, was granted home detention if he meets certain conditions of a $5 million bond. His lawyer, Robert W. Dapelo, said, “His position is that he’s innocent and when the dust settles, you will see that the allegations made by the government are not true.”

Another clinic doctor, Robert Terdiman, faces state charges of conspiracy and illegal prescription sales filed by Ms. Brennan’s office.

Dr. Terdiman’s lawyer, H. Hershel Katz, said by phone that his client, who was ordered held without bond, entered a not guilty plea to the charges.

According to the indictment, Dr. Lowe occasionally saw purported patients and wrote unnecessary oxycodone prescriptions, but he also hired other doctors and directed them to write such prescriptions, and paid the doctors based on the number of prescriptions they wrote.

Ms. Brennan’s office said that since June 2012, Dr. Terdiman wrote about 18,700 prescriptions to over 4,200 people. An analysis of Dr. Terdiman’s records showed those prescriptions yielded about three million pills, with a street value of more than $90 million, the office said.

Most of the people who crowded outside the Astramed clinic in the Bronx had been recruited and paid by oxycodone distributors, known as crew chiefs, to pose as patients to receive the medically unnecessary prescriptions from doctors, the federal indictment says.

As the indictment describes the scheme, these recruits were typically paid up to $500 for obtaining and handing over the oxycodone tablets they obtained. The crew chiefs also paid clinic employees hundreds of dollars in cash to get their recruits into the clinic to see a doctor. The “patients” could also pay extra to skip to the front of the line, the indictment says.

One crew chief recruited “patients” by targeting people who are H.I.V.-positive or who have AIDS and other illnesses and “who therefore were more likely to have established relationships with pharmacies that could fill prescriptions obtained at the clinic,” the indictment says.

The clinic also served people who were not part of the operation, like addicts and drug dealers, who could gain access to the clinic by paying an “admission” fee of $1,000 or more, the indictment charges. “This was an assembly line, not a medical clinic,” Mr. Bharara said
But meanwhile Big Pharma, they got that street name as they are big really big pushers,  have been covering up the dangers of their drugs for years. The latest is the drug Pradaxa.One of its side effects is death in the form of fatal bleeding. So not only are they con artists, they are liars and in fact murderers. And as they knew that before distributing it, selling it and paying Doctors in some form (perhaps not as direct as those above but some compensation usually changes hands) and since they are now charging DUI's in California with Murder in neglient homicide accidents, I am assuming anyone dying of neglect or malfeasance by drugs and the Doctor who prescribed them will also be charged as such. And of course the Manufacturer as an accessory. Or maybe the other way around, but let's really call the right people felons since we do that to ordinary citizens who are drug users.

And let us not forger the role of the FDA and their lack of actual supervision and regulation. We keep hearing about these government laws and bureaucracy that are killing jobs but people not so much. There are story after story from the SEC, the FDA and other agencies that have done nothing to prevent any of the accidents that are not just waiting to happen, but the ones that already have.

I don't say corrupt I say stupid, lazy and incompetent. A trait shared by both the legal and medical profession. They need a pill to fix that.

Study of Drug for Blood Clots Caused a Stir, Records Show
FEB. 5, 2014

The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.

The documents were made public last week by a federal judge in Illinois who is overseeing thousands of lawsuits filed by patients and their families, who say that Pradaxa’s manufacturer, the German company Boehringer Ingelheim, failed to properly warn them about the risks of taking the drug.

Since its approval in 2010, the drug, which can cause fatal bleeding, has brought in more than $2 billion in sales in the United States, according to the research firm IMS Health.

It has been prescribed to 850,000 patients, but has also been linked to more than 1,000 deaths.

Documents show that some of Pradaxa’s employees openly fretted about the marketing implications of the study. Many of the documents released by Chief Judge David R. Herndon of the United States District Court in East St. Louis, which included emails, memos and internal presentations, centered on whether a coming research paper would undercut one of Pradaxa’s main selling points: that it does not require regular blood tests to ensure it is working.

The issue has been hotly debated among heart and stroke specialists, in part because not all people — especially older patients — metabolize the drug the same way, and because there are fewer dose options as well as no tests available for Pradaxa in the United States to monitor those who might be most at risk. An additional dose and a test are available in Europe.

Testing is a critical issue because Pradaxa and two other recently approved drugs, Xarelto and Eliquis, are in a race to gain market share from warfarin, a generic drug that for decades has been the standard treatment for preventing blood clots and strokes. Many patients viewed the older warfarin as a nuisance because it requires frequent blood tests and careful attention to diet and other drugs.

The new drugs do not require such monitoring, yet claim to be as good, or better, at preventing strokes and blood clots in patients with a heart-rhythm disorder known as atrial fibrillation.

The documents show that Boehringer Ingelheim employees openly fretted when it appeared that the results of the research paper, written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from monitoring of their blood. A certain segment of patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.

In a draft version of the paper included in the court records, Dr. Reilly and his co-authors detailed specific levels of how much Pradaxa should be in a patient’s bloodstream, and said that keeping some patients within that range would help prevent strokes and bleeding.

As Dr. Reilly’s draft paper circulated within the company, some employees questioned what the marketing implications of such a conclusion would be.

One company supervisor, Dr. Jutta Heinrich-Nols, wrote in an email to other employees that she could not believe the company was planning to publish research that would negate a decade’s worth of work proving that patients taking Pradaxa would not need regular tests.

Publishing the research results, she warned, could make it “extremely difficult” for the company to defend its long-held position to regulators that Pradaxa did not require testing.

And, Dr. Heinrich-Nols added in the email, the research, if known, would “undermine” the company’s efforts to compete with other new anticoagulants, such as Xarelto and Eliquis.

“I would like to ask you to check again whether this is really wanted,” she wrote about publishing the research.

Another company leader, Dr. Andreas Clemens, questioned whether legal repercussions would arise if Dr. Reilly’s paper detailed a specific range where the drug worked best. “Maybe I am phobic, but I am not happy with the conclusion,” he wrote.

Still, some of the same employees acknowledged that Dr. Reilly’s paper addressed serious concerns that doctors were raising outside the company. “The world is crying for this information — but the tricky part is that we have to tailor the messages smart,” Dr. Clemens wrote in a separate email.

In emails, Dr. Reilly defended his conclusions, saying the research showed that a minority of patients might benefit from blood testing. “I think we just need to make the message clear,” he said. Dr. Reilly declined to comment, referring questions to the company’s public relations department.

The documents highlight how much information about drug safety is in the hands of people with a financial interest in the outcome, some drug industry observers said.

“With these drugs, this is a really tough call,” said Dr. Lisa M. Schwartz, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice.

“In these situations, where the stakes are really high, how crazy is it that it’s in the hands of people who are so conflicted?” she asked.

Dr. Reilly’s paper was published Tuesday in the Journal of the American College of Cardiology, and although many of the conclusions in the draft version remained, references to a patient’s optimal blood-level range no longer appear in the article.

In a statement, representatives for Boehringer Ingelheim said the recently unsealed documents “represent small fragments of the robust discussion and debate that is a vital component in all scientific inquiry, and in the research and development of any important medication such as Pradaxa.” The company said the changes to the manuscript were made as the scientists’ thinking evolved, and they ultimately concluded that no single blood-level range is ideal for all patients.

Lawyers for the plaintiffs declined to comment.

Pradaxa is approved in a 150-milligram dose, as well as a lower 75-milligram dose for patients with low kidney function. But unlike European regulators, the F.D.A. did not approve a 110-milligram dose because the agency felt the lower dose would not benefit most patients.

Boehringer Ingelheim continued to pursue the approval of the 110-milligram dose even after the higher dose was approved, but the company said it abandoned the effort after concluding that a proposed study and other analyses were not feasible.

Some doctors applauded Boehringer Ingelheim for finally addressing an area of intense interest among cardiologists. Dr. Hugo ten Cate, a professor of medicine at Maastricht University Medical Center in the Netherlands who has called for more monitoring of patients on the new blood thinners, said there had been a “lively discussion” about this issue.

“The company was initially reluctant to recommend anything about monitoring, because they were claiming you no longer have to monitor anymore,” said Dr. ten Cate, who said he had received payments from Boehringer Ingelheim and other companies to speak on such issues, and who also heads a Dutch association of warfarin-testing clinics. “But now, they’ve gradually come back a little bit.”

Others said the newly released documents show that drug makers and regulators had been too eager to approve such powerful drugs without more careful monitoring.

“The one-size-fits-all was a mistake for a drug with this kind of risk,” said Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices, which keeps track of safety reports submitted to the F.D.A. He rated anticoagulants — including warfarin and Pradaxa — as the most serious safety problem in 2011 and 2012. He said Pradaxa has been cited in more than 1,000 deaths reported to the agency through the end of 2012.

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