Wednesday, November 20, 2013

Stress Test Chemicals Could Cause Heart Attacks And Death, FDA Warns

Nov 20 (Reuters) - The U.S. Food and Drug Administration warned physicians on Wednesday that two chemicals used to conduct cardiovascular stress tests can cause heart attacks and death, and it suggested resuscitation equipment and trained staff be available when the tests are conducted.

The injectable products, Lexiscan and Adenoscan, are marketed by Astellas Pharma US Inc. They work by stressing the heart, allowing physicians to take images that can show areas of low blood flow and damaged heart muscle. The tests are given to patients who are physically unable to exercise.

The FDA said heart attacks may be triggered by the tests because the chemicals dilate the heart's arteries and increase blood flow to help identify obstructions. Blood flows more easily to unblocked arteries, which can reduce blood flow to an obstructed artery. In some cases, that can lead to a heart attack, the agency said.

The FDA advised physicians not to use the products in patients with signs of acute myocardial ischemia, which occurs when blood flow to the heart muscle is decreased. Some cases of heart attack and death have occurred in patients with unstable angina, or chest pain, and other heart problems.

The FDA said it analyzed its safety database for Lexiscan for side effects reported between June 24, 2008, and April 10, 2013, and for Adenoscan from May 18, 1995, to April 10, 2013, correlating with the start of marketing for each drug.

The database contained 26 heart attacks and 29 deaths following administration with Lexiscan, and six heart attacks and 27 deaths following administration with Adenoscan. The reports did not always specify when the events occurred, but when the timing was specified, they tended to occur within six hours of a stress test, the FDA said.

Wednesday, November 13, 2013

New heart guidelines could put more Americans on statins

The updated recommendations for treating cholesterol are "a huge, huge departure" from doctors' usual procedure.

Twice as many Americans will be eligible for cholesterol-lowering drugs, based on controversial new heart guidelines from two of the USA's leading cardiovascular associations.

The number of adults considered likely to benefit from statins will rise from about 15.5% today to 31%, according to the new criteria, developed by the American College of Cardiology and the American Heart Association, in collaboration with the National Heart, Lung and Blood Institute. While statins have been widely prescribed to reduce the risk of heart attacks, the new guidelines recommend that they also be considered for people at high risk of stroke.

That advice could lead doctors to prescribe statins to millions more people, says Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who wasn't involved in the new guidelines.
"It's going to cause a huge conversation," says Mariell Jessup, president of the heart association. "It may be very controversial — which is fine. Controversy means discussion."

Authors of the new guidelines say they hope to get statins to more patients who need them, while avoiding unnecessary prescriptions for people unlikely to benefit.
The guidelines also call for doctors to work closely with patients to improve their diets and increase exercise.

Rita Redberg, a professor at the University of California-San Francisco, says she is concerned about exposing more patients to statins' side effects, which include an increased risk of diabetes, as well as muscle pain.

The average patient is likely to notice two major changes in the way that doctors manage their cholesterol, experts say.
For years, doctors often prescribed statins based on patients' cholesterol levels, especially their LDL, known as "bad" cholesterol. The new guidelines advise doctors to base their decisions on a patient's overall risk, rather than just their cholesterol. Nissen notes that even patients with normal cholesterol can have heart attacks.

"It's a huge, huge departure from the way that people have been thinking about cholesterol and heart disease," says Harlan Krumholz, a professor at the Yale School of Medicine. "Doctors today are obsessed with numbers."

The guidelines identify four high-risk groups who could benefit from statins: people with pre-existing heart disease, such as those who have had a heart attack; people ages 40 to 75 who have diabetes; patients ages 40 to 75 with at least a 7.5% risk of developing cardiovascular disease over the next decade, according to a formula described in the guidelines; and patients with the sort of super-high cholesterol that sometimes runs in families, as evidenced by an LDL of 190 milligrams per deciliter or higher.

These changes will help doctors to focus not just on "lab values," but on the whole patient, including a patient's weight, blood pressure, use of tobacco, diet, physical activity and other considerations, Krumholz says.

Doctors have focused heavily in recent years on using drugs to reduce LDL to certain benchmark levels: under 130 for most people; 100 for people at high-risk; under 70 for those at the highest risk, such as those who have just survived a heart attack. Doctors have raised or lowered medication doses to help patients meet these targets, Nissen says.

Monday, November 4, 2013

Johnson & Johnson To Pay $2.2 Billion To Resolve Drug Marketing Allegations

WASHINGTON (AP) — Johnson & Johnson has agreed to pay over $2.2 billion to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs for unapproved uses in children, seniors and disabled patients, the Department of Justice announced on Monday.

The agreement is the third-largest settlement with a drugmaker in U.S. history, and the latest in a string of actions against drug companies allegedly putting profits ahead of patients.
Justice Department officials alleged that J&J used illegal marketing tactics and kickbacks to persuade physicians and pharmacists to prescribe Risperdal and Invega, both antipsychotic drugs, and Natrecor, which is used to treat heart failure.

"J&J's promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society — children, the elderly and those with developmental disabilities," said Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania.

The settlement amount includes $1.72 billion in civil payments to federal and state governments as well as $485 million in criminal fines and forfeited profits.

Monday's action is the latest example of regulators cracking down on aggressive pharmaceutical marketing tactics, namely trying to increase sales by pushing medicines for unapproved, or "off-label," uses. While doctors are allowed to prescribe medicines for any use, drugmakers cannot promote them in any way that is not approved by FDA.

"Every time pharmaceutical companies engage in this type of conduct, they corrupt medical decisions by health care providers, jeopardize the public health, and take money out of taxpayers' pockets," said Attorney General Eric Holder.  J&J said in a statement, "This resolution allows us to move forward."

The FDA first approved Risperdal tablets for schizophrenia in 1993, but prosecutors say J&J began promoting the drug for unrelated uses by the end of the decade. Risperdal then grew to become J&J's top product by 2005, with sales over $3.5 billion.

In its plea agreement, J&J subsidiary Janssen Pharmaceuticals admitted to promoting Risperdal as a way to control erratic behavior in seniors with dementia. Today that use is explicitly barred in the drug's warning label because it can increase the risk of stroke and death in elderly patients.
Janssen agreed to plead guilty to violating drug marketing laws and will pay $400 million in fines and forfeited sales.

In a separate civil complaint, the government alleged that J&J and Janssen promoted Risperdal and a similar drug, Invega, to control numerous behavioral problems in seniors, children and the mentally disabled between 1999 and 2005.

Documents filed in the case show the government raised objections about the company's marketing approach for years. In a 1999 letter, the FDA warned Janssen that "disseminating materials that state or imply that Risperdal has been determined to be safe and effective for the elderly population" would be "misleading."

Despite such warnings, the company's marketing plan targeted nursing homes and doctors who treated the elderly. Marketing materials distributed by an "ElderCare sales force" emphasized Risperdal as a treatment for seniors suffering from everything from agitation to depression to hostility. The company also downplayed the drug's risks, including diabetes and weight gain.

At the same time the drugmaker was allegedly paying kickbacks to the nation's largest nursing home pharmacy, Omnicare. J&J paid millions in bogus grants and education payments to persuade the company's hundreds of pharmacists to recommend Risperdal to nursing homes. The government said the payments amounted to kickbacks.

The company also set business goals to increase drug sales to children and adolescents. Janssen instructed its sales representatives to call on child psychiatrists and to market Risperdal as a treatment for common childhood disorders, such as attention deficit disorder and autism.
Prosecutors said Monday the off-label prescribing contributed to millions of dollars of wasteful federal and state spending by health programs like Medicare, Medicaid and the Department of Veterans' Affairs.

"Through these alleged actions, these companies lined their pockets at the expense of American taxpayers, patients and the private insurance industry," Holder said.
In a separate civil complaint, the government alleged that J&J and its subsidiary Scios promoted its heart failure drug Natrecor as a weekly treatment for patients, despite no scientific evidence to support this approach.

J&J and Scios agreed to pay $184 million to settle civil allegations surrounding the drug.
Both state and federal governments are spending more than ever on prescription drugs, as Medicare and Medicaid swell with aging baby boomers. That increased spending has attracted scrutiny from prosecutors looking to recover taxpayer dollars.

Last year British drugmaker GlaxoSmithKline paid a record $3 billion in fines to settle criminal and civil violations involving 10 of its drugs. Prior to that, the record settlement involved Pfizer Inc., which paid $2.3 billion in criminal and civil fines.
In its most recent quarterly filing, New Brunswick, N.J.-based J&J reported $17.3 billion in cash on hand.

Friday, November 1, 2013

Multiple sclerosis rates two times higher among dairy workers than other occupations

(dailyRx News) Scientists still don't know what causes multiple sclerosis (MS). It could be viruses, genetics or environmental factors, or a combination of all three. One new study suggests it could be the kind of work people do.

The results of that study showed that dairy workers in a certain Danish population had higher rates of MS than people in other lines of work.
This research is the first to show an increased risk of MS in dairy workers.
While the researchers could not explain what caused this increased risk, they did mention previous studies that have linked cow's milk to MS.

This study, led by Henrik Horwitz, MD, of Bispebjerg Hospital at the University of Copenhagen in Denmark, was sparked by a finding that Dr. Horwitz and colleagues made some years back.
In 2006, while looking at critical illness insurance claims from a Danish pension fund, these researchers noted a high number of claims made by patients diagnosed with MS who worked in agriculture.

Critical illness insurance is an insurance plan that pays policyholders in a lump sum when they are diagnosed with a critical illness.
According to the researchers, these agricultural workers — made up of dairy workers, gardeners and agricultural assistants — had the lowest rates of critical illness in general. So why did MS seem to pop up so often?

Previous research has suggested that vitamin D, which most people get from being exposed to the sun's UV light, may protect against MS. Other research has shown an association between cow's milk and risk of MS.

For this current study, Dr. Horwitz and colleagues set out to see if gardeners or dairy workers had a higher risk of developing MS compared to other workers in PensionDenmark, a pension fund that insures more than 300,000 Danish workers.

Over the course of 10 years, 389 people were diagnosed with MS. The rate of MS among men was 10.2 per 100,000 men. Among women, that rate was 16.1 per 100,000.
The highest rate of MS was found among agricultural workers.
After looking a little deeper, the researchers found that this high rate of MS among agricultural workers could be tracked more specifically to dairy workers, who were two times more likely to develop MS than any of the other workers.

"Interestingly, dairy operators had the highest risk of developing MS, and the tendency was found both among men and women," the study authors wrote. "We were puzzled by the finding of an increased risk of MS among members of the agricultural segment of the pension fund, because this would seem to go against the vitamin D and sun exposure hypothesis. However, it became clear that dairy operators constituted one-third of this cohort, and this seemed to explain our findings."

Simply put, the researchers were surprised at first to find the increased risk of MS in agricultural workers, since many of these workers are typically outside getting that protective vitamin D from the sun. But then they saw that so many of the agricultural workers in this pension fund worked in the dairy sector, which doesn't require as much outdoor activity.

"No previous research has identified an increased risk of MS in dairy operators, so is this a coincidence? Or is it a clue to etiology (the origin or causes of disease)?" the researchers asked.
They went on to cite past research that has linked cow's milk to MS risk but concluded that this question should be studied further.

This study was published June 25 in BMJ Open