29 November 2011

Blood Thinner Increases Heart Survival

Story first appeared in Bloomberg News.

Johnson & Johnson and Bayer AG’s blood-thinner Xarelto cut by 16 percent the risk of a subsequent heart attack, stroke or death from heart disease in patients who recently suffered a cardiac event, according to a study.

The data makes Xarelto the first in a new class of blood thinning medicines to show effectiveness for acute coronary syndromes, or ACS, when used in addition to standard treatment. The lowest dose, given twice daily, slashed deaths by one-third.

Xarelto was approved Nov. 17 in the U.S. to prevent strokes in people with atrial fibrillation, an irregular heartbeat that affects more than 2 million Americans. The data reported today at the American Heart Association meeting in Orlando, Florida, may create a new use in
1.2 million patients hospitalized yearly with ACS, which includes heart attack and severe chest pain. It’s a $1.4 billion market, said an analyst with Sanford C. Bernstein & Co. in San Francisco

A halo effect from having good ACS data could improve physicians overall perception of Xarelto and, importantly, help gain better coverage from payers.

Xarelto competes with Pradaxa from Boehringer Ingelheim GmbH of Ingelheim, Germany in the atrial fibrillation market. Another rival drug, Eliquis from Pfizer Inc. and Bristol-Myers Squibb Co., both based in New York, presented positive trial results in atrial fibrillation at a conference in August.

50-Year-Old Warfarin

All three drugs are attempting to replace warfarin, a more than 50- year-old medicine that is a form of rat poison. The Xarelto study was funded by New Brunswick, New Jersey-based Johnson & Johnson, which owns U.S. rights, and Leverkusen, Germany-based Bayer, which sells the treatment in Europe.

Until today’s results, it wasn’t clear that the new class of drugs would also work in acute coronary patients, who are treated with aspirin and the blood thinner Plavix from Paris- based Sanofi and Bristol. Pfizer’s Eliquis flopped in a trial of ACS patients a year ago, failing to prevent heart attacks and cardiac deaths while causing significantly more major bleeding.

A study of Merck & Co.’s vorapaxar, also presented at the meeting, boosted rates of severe bleeding in the brain more than three-fold and failed to reduce deaths, heart attacks, strokes and other complications in high-risk heart patients.

Low Doses

In the new trial, doctors used very low doses of Xarelto given twice daily and excluded patients with prior stroke treatment to minimize bleeding.

Still, patients on Xarelto had a more than 3- fold increase in major bleeding episodes. The rate of fatal bleeding did not increase significantly, according to results being published in the New England Journal of Medicine in conjunction with the conference.

Bayer has estimated that sales of Xarelto will top $2.8 billion annually. The companies plan to file for FDA approval for the acute coronary use by the end of the year. They will ask the FDA for a priority review, though it hasn’t decided whether it will request approval of both doses or just the lower dose, DiBattiste said.

Trenton Heart Doctors said the drug could improve care for acute coronary syndrome patients.

Study Results

Patients in the new Xarelto trial were given 2.5 milligrams of Xarelto, 5 milligrams of Xarelto or a placebo twice a day. Everyone also took aspirin and the vast majority used Plavix.

Taylor Heart Doctors followed the patients for a median of 13 months. Heart attacks, stroke and death from cardiovascular disease occurred in 8.9 percent of patients given Xarelto, compared with 10.7 percent of those on placebo.

Death from cardiovascular disease was reduced by 34 percent in the low- dose arm compared with placebo, while deaths from any cause were down 32 percent. The higher 5 milligram dose didn’t reduce mortality rates, for reasons that aren’t totally clear.

Doctors would need to treat 56 patients a year with Xarelto to prevent one death, the researchers calculated.

Bleeding Risk

Still, the increased bleeding seen with Xarelto is something doctors and patients need to keep in mind when determining treatment, experts at a Taylor Stroke Care center say.

Major bleeding episodes occurred in 2.4 percent of patients on the high dose of Xarelto and 1.8 percent of those on the low dose, versus 0.6 percent of those on placebo.

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Florida Shuts Down Pill Mills

Story first appeared in USA TODAY.

When federal agents arrested a man with 6,000 oxycodone pills in a Stamford, Conn., hotel room in April, they stumbled onto an expansive criminal ring that exposed a growing trend: drug tourism.

The man, whom the Drug Enforcement Administration (DEA) has not identified because he is a witness in the case, told agents he traveled to Florida several times a week, taking advantage of lax laws governing pain clinics to purchase large quantities of prescription painkillers. His suppliers in Florida would send large groups of people into pain clinics with cash and medical cards to feign illness and buy the pills.

The man would return to Connecticut to sell them for a huge profit, bribing airport security officers and police so he could transport as many as 8,000 pills each trip.

He made more than 65 trips from November to April, court papers say. The ring involved more than a dozen people who sold tens of thousands of pills to addicts in Connecticut during the past year, U.S. Attorney David Fein said.

The case illustrates how drug dealers and addicts in search of potent prescription painkillers such as Vicodin and OxyContin are traveling to Florida and other states with lax prescription-drug laws to get their fix. Police say they have found drug tourists dead of overdoses in hotels and rental cars.

Now states are trying to outsmart the criminals by tracking prescriptions through statewide databases and by toughening their laws to make it more difficult for unscrupulous clinics to dispense large numbers of prescription pain pills. And in the latest move against drug tourists, states are linking their databases to try to stop dealers from roaming state to state.

Selling such prescription drugs is so profitable that dealers and operators of the high-volume pain clinics — known to authorities as pill mills — quickly find ways around the new laws or set up shop in another state to avoid them.

About 7 million people regularly use prescription drugs for non-medical purposes, the 2010 National Survey on Drug Use and Health found. The Centers for Disease Control and Prevention calls prescription-drug abuse a national epidemic. Prescription drugs, including narcotic pain relievers and anti-depressants, cause more overdose deaths than street drugs such as cocaine, heroin and methamphetamine, the CDC says.

In Florida, the problem has been devastating: The death rate from oxycodone increased 265% from 2003 to 2009, the CDC found. By 2009, the number of deaths involving prescription drugs was four times the deaths involving street drugs, the CDC said in a July report.

All but two states — Missouri and New Hampshire— have enacted laws that set up prescription drug monitoring programs.

The databases track prescriptions like those for Fibroids so doctors can access patients' records to determine whether they already have multiple orders for a narcotic. Pharmacists can flag police if they suspect a doctor or clinic is dispensing an unusually large amount of painkillers. Police can use the records to bolster their cases against pill mills that dispense massive quantities of pain pills with little or no examination of patients.

In August, Kentucky and Ohio became the first states to link their databases to make it tougher for addicts in one of the states to avoid detection by visiting a doctor in the other. Those states joined with West Virginia and Tennessee in an interstate alliance to coordinate databases, laws and investigations to try to keep pill mills shut down in one state from popping up across the border.

Kentucky and Ohio have already broken the code, says former executive director of the Governor's Office of Drug Control Policy in Florida. By agreeing to provide information to pursue investigation, you won't have people jumping back and forth over state lines and doing this with impunity.

Last month, the National Association of Boards of Pharmacy launched a database hub that allows a doctor or pharmacist to retrieve painkiller prescription data from any state linked into the hub, Executive Director Carmen Catizone says. Ohio, Indiana and Virginia have linked in and 20 other states have agreed to do so this year.

Addicts and dealers are clever, says Sherry Green, CEO of the National Alliance of Model State Drug Laws. They will cross borders to escape their state's tracking system or move a pill mill to another state if they think law enforcement is nosing around.

Here are people from Kentucky going down to Florida all the time, and it's not just the person who is addicted. You also have people who make a profit on it.

Dealers are willing to travel long distances if they feel they can make money selling the drugs on the black market.

Pills purchased in a Florida pharmacy cost $4 to $6 for a 30-milligram tablet, DEA Special Agent says. That tablet would sell for $30 on the street in Connecticut.

It's been a disaster for Florida

Until Florida enacted tough laws on Sept. 1, the Sunshine State was the undisputed epicenter of prescription-painkiller distribution. Of the estimated 53 million oxycodone doses sold in 2010 to medical practitioners in the USA, nearly 45 million were purchased in Florida.

It's been a disaster for Florida.

Drug tourism emerged as a major problem. Agents routinely saw out-of-state license plates jamming the parking lots outside the rogue clinics. The state averaged seven deaths a day from prescription-drug overdoses, and local police chiefs had their hands full with related crimes.

People would do deals right outside the pill mills. Other people would feed off them. They had burglaries, thefts of pills from cars. It even resulted in a murder.

Terry Williams, 46, of Johnson City, Tenn., was beaten and strangled for his stash of oxycodone pills, police said. A maid at the Red Roof Inn in Oakland Park, Fla., found Williams dead in his hotel room on April 29, 2010.

Williams had arrived from Tennessee three days earlier with his ex-wife, Sandy Bulla, their 5-year-old son and a friend, Gregory Brummitt, 20, to buy narcotics at a pill mill, sheriff's deputies said in their report. With the child in the room, Bulla and Brummitt allegedly beat Williams to death, took his 200 pills and $1,600 and fled in Williams' pickup truck. Bulla and Brummitt are charged with murder and are being held without bail in Broward County Jail.

If you're in Tennessee, you've got to have a reason to drive to Florida. You're not doing it for the scenery. These people will try to find the path of least resistance. Florida used to be the path of least resistance.

Florida's laws were so lax that dealers and addicts created elaborate, organized networks to obtain the pills and bring them back to Kentucky, says Van Ingram, executive director of the Kentucky Office of Drug Control Policy.

The Florida Legislature had passed a law to establish the drug database, but Florida Gov. Rick Scott's budget did not include funding for the program and included a provision that would repeal the law.

Pressure increased. The governors of West Virginia and Kentucky and four U.S. senators wrote a letter in February to Scott urging him to fund Florida's prescription-drug monitoring system. In March, Purdue Pharma, the manufacturer of OxyContin, offered Florida $1 million to support the prescription-drug database.

Meanwhile, local police teamed with the DEA to identify hundreds of clinics and conduct dozens of raids.

In just six months, Florida has attacked from every angle what can only be described as a homegrown prescription drug epidemic.

In June, Scott signed a compromise law that requires doctors to use tamper-proof prescription pads or electronic prescribing, toughens penalties for doctors who overprescribe painkillers and bans most doctors from dispensing the drugs.

The new law allows the prescription-drug database to operate and shortens from 15 days to seven the amount of time pharmacists have to report prescription information. It prohibits pharmaceutical companies from funding the database. A private foundation is paying for it with $750,000 in federal grants and donations.

The law marks the beginning of the end of Florida's infamous role as the nation's pill mill capital.

The database is going to catch some, it's going to deter some others. But it's not an instant fix. It's going to take a few months for the database to build to a point where it's useful.

Because the new law prohibits doctors and clinics from dispensing the pain medicine on-site, patients must go to a pharmacy to fill their prescriptions. Now federal agents say they will be focused on rogue pharmacies.

Applications for pharmacies have doubled over the past year. Pill mill operators just go next door and try to open up a pharmacy.

Ingram of Kentucky says Florida's big busts and new laws are beginning to discourage Kentucky's drug shoppers.

Concerns rising in New England

As pill mill operators felt the heat in Florida, some headed north, and problems emerged in Georgia.

During the past 18 months, Georgia has seen a steady increase in pill mills setting up shop in Atlanta-area strip malls and near interstate highways, says Inspector Fred Stephens of the Georgia Bureau of Investigation.

Georgia's Legislature has approved a prescription drug monitoring program, but it won't be ready until January 2013.

Addicts and dealers come from Ohio, Tennessee, Maryland, Kentucky and other states to visit the clinics, which usually accept all walk-in patients and want to be paid in cash, Stephens says. Often, large groups will come in vans, old medical records tucked under their arms, he says.

Last year, prescription-drug overdoses in Georgia increased at least 10% — to 560 — from 2009, a study by the bureau's medical examiner found. The study did not include the Atlanta area.

Now, Derr of Connecticut worries that with the Southern states cracking down on drug tourism, pill mills will emerge in New England. He recently saw an ad on Craigslist in Connecticut from a clinic looking to hire doctors.

28 November 2011

100,000 Seniors Hospitalized Yearly for Adverse Drug Reactions

Story first appeared in USA TODAY.

An estimated 100,000 older Americans are hospitalized for adverse drug reactions yearly, and most of those emergencies stem from four common medications, a new study finds.

The four types of medication -- two for diabetes and two blood-thinning agents -- account for two-thirds of those drug-related emergency hospitalizations.

Of the thousands of medications available to older patients, a small group of blood thinners and diabetes medications caused a high proportion of emergency hospitalizations for adverse drug events among elderly Americans.

Medications previously designated "high-risk" were implicated in only 1.2 percent of hospitalizations, the study found.

Working with a nationally representative database, CDC researchers identified more than 5,000 cases of drug-related adverse events that occurred among people aged 65 and older from 2007 to 2009 and used that to make their estimates for the whole population.

Nearly half (48 percent) of the hospitalizations occurred among adults 80 and up, according to the study, published in the Nov. 24 issue of the New England Journal of Medicine. Nearly two-thirds (66 percent) were the result of unintentional overdoses.

The four medications, used alone or together, most often cited:

The blood thinning medication warfarin (Coumadin, Jantoven), which is used to treat blood clots, was involved in 33 percent of emergency hospitalizations.

Insulin, used to control blood sugar in diabetes patients, was involved in 14 percent of cases.

Antiplatelet drugs such as aspirin and clopidogrel (Plavix), which are used to prevent blood clots, were involved in 13 percent of cases.

Oral hypoglycemic agents -- diabetes medications taken by mouth -- were involved in 11 percent of cases.

With antiplatelet or blood thinning drugs, bleeding was the main problem. For insulin and other diabetes medications, about two-thirds of cases involved changes in mental status such as confusion, loss of consciousness or seizures.

This study highlights a few key issues that are important for doctors and patients to be aware of. The first is that serious adverse reactions to drugs are common among older people, particularly among people over 80. But even those 65 and older are at substantial risk of having an adverse effect from their drugs.

One challenge for doctors and patients is that the medications may be necessary.

These are often critical medicines for patients' health. Patients who are on these medicines should tell all their doctors what they are taking and work together with their doctors and pharmacist to make sure that they are taking these medicines correctly.

Among U.S. adults aged 65 and up, 40 percent take five to nine medications and 18 percent take 10 or more, according to the study authors. Prior research has also found that older adults are nearly seven times more likely than younger people to have an adverse drug event that requires hospitalization. As most people age, there often are changes in how their kidneys, liver, heart, and other organs work that can make them more susceptible to adverse drug events.

And though taking lots of pills raises safety issues, in 82 percent of cases the treating physician attributed the overdose to a single drug.

To reduce risks, Steinman said doctors and patients need to discuss whether the drug is truly necessary. For people with very high blood pressure or blood sugar, the answer is almost always "yes," you should treat it. But if you have only mildly elevated blood pressure or blood sugar, the benefits of treating it versus the harms start to shift. Do these drugs really provide enough benefit that it's worth taking them?

Physicians and patients need to consider a person's age, overall health, other medications they take (keep a list including dosages) and patient preference, such as how easy they find it to keep track of blood sugar and dosages, he said.

With anticlotting or blood-thinning agents, stopping them is probably not an option, Steinman said. So patients need to be attuned to any side effects they experience, even if they seem minor. Catching side effects early can prevent more serious problems later on, and doctors may be able to change the medication or lower the dosage, he said.