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Celexa, Lexapro Promotions Questioned


Even though Lexapro and Celexa were both proven to promote suicidal thoughts in children, Forest Laboratories chose to market its antidepressants to pediatric patients anyway, prosecutors at the U.S. Justice Department have charged.

According to the Wall Street Journal (WSJ), the same prosecutors have charged that Forest Labs also violated anti-kickback laws by paying doctors to prescribe Lexapro and Celexa to vulnerable, pediatric patients. A lawsuit filed by the department now accuses the drug maker of violating the False Claims Act when it marketed the drug, The civil complaint also accuses Forest of covering up a medical study that concluded that Lexapro and Celexa were not effective medications for children, said WSJ. The complaint was unsealed in Boston federal court yesterday.

According to, the complaint charges that Forest was unwavering in its marketing of the drugs. Knowing that they were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs and hiding the negative findings. Meanwhile, the U.S. Food and Drug Administration (FDA) never approved the drugs for use in children.

According to the DOJ, Forest’s bribes and inappropriate marketing resulted in false claims submission for reimbursement to federal health care programs said the Journal. Bribes included not just cash payments—falsely described as grants and consulting fees—but pricey meals and other expensive gifts which violated anti-kickback laws, said Bloomberg. “By knowingly and actively promoting these antidepressants for off-label pediatric use without disclosing the results of the negative pediatric study, and by paying kickbacks, Forest caused false claims to be submitted to federal health care programs,” Massachusetts U.S. Attorney Michael Sullivan said in the complaint, reported Bloomberg.

Now, under the federal False Claims Act, the DOJ is looking for triple the financial damages from Forest in addition to other penalties; the total compensation sought is unknown, said the Journal. Bloomberg noted that under the Act, the government is eligible to receive treble damages and civil penalties of up to $11,000 per violation.

This case and others may be evidence that the DOJ is making a concerted effort to crack down on the illegal drug marketing practices. The Journal pointed out that just last week, the DOJ joined a whistle blower lawsuit against Johnson & Johnson in which the drug maker is charged with illegally marketing its cardiac medication Natrecor. Also, last month, Pfizer Inc. and Eli Lilly & Company both agreed to payouts in two separate cases involving illegal marketing, said the WSJ. Pfizer agreed to pay over $2 million in response to charges it illegally promoted it now-withdrawn painkiller Bextra. Eli Lilly agreed to pay $1.4 billion in fines to settle similar claims over its antipsychotic Zyprexa.

Posted: 2/27/2009 10:22:00 AM

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Pfizer cancels development of two late-stage drugs

From Reuters:

Pfizer, Inc. said it is dropping two drugs in late-stage development -- one for anxiety and one for fibromyalgia -- after data showed they would not work much better than existing treatments.

The dropped drugs are the latest casualties of the No. 1 drugmaker's sputtering research engine. Earlier this year the company halted a late-stage trial of a drug that failed to improve survival in pancreatic cancer patients and last year it dropped a late-stage obesity drug.

Pfizer said on Tuesday it is canceling its fibromyalgia drug esreboxetine, as well as a drug for generalized anxiety disorder known as PD 332,334.

Pfizer, which is desperately searching for new products to replace its $13 billion-a-year cholesterol drug Lipitor, which goes off patent in late 2011, said it plans to focus on products that address unmet medical needs.

Pfizer said it will continue to pursue an application for its drug Lyrica as a treatment for chronic anxiety disorder. Lyrica is already approved to treat epilepsy and fibromyalgia, a condition characterized by chronic pain and fatigue.

The company said it plans to focus its attention on areas where there are few effective treatments. It said it is moving forward with an experimental drug, tanezumab, in broad areas of pain management. It is already studying the drug in patients with osteoarthritis.

In addition, the company sees potential opportunities for its experimental drugs to treat Alzheimer's disease and thrombosis.

And from The Washington Post:

Pfizer's own Lyrica, originally approved for epileptic seizures, became the first drug approved for fibromyalgia in the U.S. in June 2007. Then rival Eli Lilly & Co.'s Cymbalta, an antidepressant, won U.S. approval as a treatment for fibromyalgia in June 2008, and Forest Laboratories Inc. and Cypress Bioscience Inc. received approval for their drug Savella in January.

Cymbalta was approved to treat generalized anxiety disorder two years ago. Other psychiatric drugs, while not specifically approved for generalized anxiety disorder, also are used to treat it.

Pfizer said it will continue to pursue approval for using Lyrica to treat generalized anxiety disorder, a chronic condition with symptoms including persistent anxiety, exaggerated worry and tension that impairs daily function.

Posted: 2/25/2009 9:26:00 AM

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Some good news about vitamins

From the Los Angeles Times:

It’s a good week for vitamins and minerals in the Archives of Internal Medicine.

Tuesday’s edition includes a study of nearly 500,000 men and women that linked calcium to a reduced risk of cancer. The report looked at calcium consumption from food and supplements among participants in the National Institutes of Health AARP Diet and Health Study. Subjects were at least 50 years old when the study began, and they were tracked for an average of seven years.

Among women, the risk of being diagnosed with any kind of cancer fell in inverse proportion to the amount of calcium consumed from food, up to a limit of 1,300 milligrams per day. (The Institute of Medicine recommends adults age 50 and older get 1,200 mg of calcium per day.) Pills, however, didn’t contribute to the benefit.

Calcium didn’t help men reduce their overall cancer risk, but it did appear to ward off cancers of the digestive system. The 20% of men who consumed the most calcium through food and supplements were 16% less likely to get one of those cancers than the 20% of men who consumed the least calcium.  For women, those who got the most calcium had a 23% lower risk of digestive system cancers compared with those who got the least.

A second study found that vitamin D might reduce the risk of catching a cold. Researchers examined levels of vitamin D in the blood of 18,883 Americans who participated in the Third National Health and Nutrition Examination Survey and sorted them into three groups.

After controlling for factors like age, gender and smoking status, they found that people in the lowest group had a 36% increased risk of coming down with a cold compared with those in the highest group. People in the intermediate group saw their risk rise by 24%.

The effect of vitamin D was greatest for people with asthma — subjects in the group with the lowest vitamin D levels were nearly six times as vulnerable to colds as those in the highest-level group. For people with chronic obstructive pulmonary disease, low levels of vitamin D more than doubled the risk of a cold.

Neither of those studies was the kind of randomized controlled clinical trial that scientists find most persuasive. But a third study that pitted vitamin B compounds against a placebo found the vitamins reduced the risk of developing age-related macular degeneration (AMD), the most common form of severe, irreversible vision lost among older Americans.

The study piggybacked on the Women’s Antioxidant and Folic Acid Cardiovascular Study, a trial involving an amino acid found in blood called homocysteine that, at high levels, appears to increase the risk of heart disease. Since high levels of homocysteine have also been implicated in AMD, researchers decided to see whether they could prevent vision loss by attacking homocysteine with folic acid and antioxidant B vitamins.

A total of 2,607 women took a combination of 2.5 milligrams of folic acid (also known as vitamin B9), 50 milligrams of vitamin B6 and 1 milligram of vitamin B12 each day; another 2,598 women got dummy pills. During the course of the study 55 women in the treatment group developed AMD, compared with 82 among women taking the placebo. The researchers concluded that the vitamins reduced the risk of AMD by 34%.

All three studies were funded by the National Institutes of Health.

Posted: 2/24/2009 2:21:00 PM

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Final Stimulus Package Provides $21.5B for Research

From Genetic Engineering & Biotechnology News:

President Obama yesterday signed the $787 billion stimulus package into law, providing a bonus of $21.5 billion in science and research spending. The president called the measure “the biggest increase in basic research funding in the long history of American’s noble endeavor to better understand our world.” 

In good news for the biotech industry, the NIH will receive $8.5 billion for research grants and $1.5 billion to upgrade research facilities. Life sciences researchers and patient groups have been pushing for higher NIH funding in recent years, as the agency’s budget failed to keep up with medical inflation after doubling from 1998 to 2003.

In addition to the NIH boost, the stimulus package’s R&D provisions also include $3 billion for the NSF, $4.5 billion for renewable energy research including bioethanol and other biotech solutions, $1.1 billion for grants for disease prevention, $1 billion for NASA, $830 million for the National Oceanic and Atmospheric Administration, and $1.1 billion for comparative effectiveness research.

Expect that last item to generate controversy going forward. Comparative effectiveness research pits established therapies against one another to provide guidance to physicians and patients. The biotech and pharmaceutical industry has supported comparative effectiveness research that focuses on clinical outcomes but has consistently opposed cost- or value-oriented research, which will be the focus under the stimulus package.

The stimulus package also provides $17.2 billion in incentives to promote the adoption of improved healthcare information technology systems in clinics and hospitals receiving Medicare and Medicaid. In addition, tens of billions have been provided to shore up Medicaid and help unemployed workers pay for extensions of their health insurance coverage under federal COBRA rules.

Altogether, these measures, totaling $152 billion, could have a major impact on healthcare as administration and Congress prepare to take on reform in earnest.

Posted: 2/24/2009 2:16:00 PM

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FDA cites acid imbalance with epilepsy drug

From The Associated Press:

Federal health officials warned doctors Monday that a drug used in epilepsy patients can cause chemical imbalances in the blood, leading to heart problems and other serious complications.

The Food and Drug Administration said recent data show patients taking the antiseizure pill Zonegran face higher risk of metabolic acidosis, which causes dangerously high levels of acid to accumulate in the blood. The imbalance can cause breathing difficulties, irregular heart rhythms and fatigue.

Left untreated, the condition can do long-term damage to the kidneys and bones and slow growth in children.

FDA advised physicians to monitor patient's blood serum levels while they are taking Zonegran, even if they don't have symptoms. The agency said it will work with drugmakers to add new warning information labels to the drug.

Zonegran is sold by Woodcliff, N.J.-based Eisai Inc.

"We've been in discussions with FDA regarding the issue and have submitted a proposed label change for the agency to review and approve," said company spokeswoman Judee Shuler.

The drug is also available under its generic name zonisamide from various manufacturers.

Data reviewed by the FDA showed patients taking higher doses of the drug were more likely to develop metabolism problems, though they were also seen at low doses. Patients with kidney disease, diarrhea and breathing problems are predisposed to suffer acid imbalances.

Posted: 2/24/2009 8:53:00 AM

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Report: U.S. forensic science system direly needs to be toned up

From TopNews:

The United States’ forensic science system is gravely scattered and direly needs improvements – says a congress mandated report scripted by the nation’s premier scientific body. The National Academy of Sciences’ report, which is based on a broad study of forensic techniques, was released on Wednesday.

According to study, the nation’s forensic labs are not getting adequate funds; they lack in scientific basis; and consequently there are “critical delays in analyzing physical evidences”.

Funded by Congress, the study - "Strengthening Forensic Science in the United States: A Path Forward," articulates that the nation needs a new federal agency to govern these laboratories, standardize and tone up the forensic techniques and provide funds for researches.

The study was commenced in 2007 when Congress authorized the National Academy of Sciences to study forensic practices in the United States. The committee of the United States National Research Council, the working arm of the United States National Academy of Sciences, found that “the criminal and civil litigation rely on forensic science, but forensic science does not have adequate resources, talent, standards, and governance”.

The committee, in its study, counted a backlog of 359,000 requests for forensic analysis in 2005; a 24 % increase in delays since 2002. The study found that 80 percent of crime laboratories were understaffed.

Commenting to the report, the Committee co-chair and senior circuit judge and chief judge emeritus of the U.S. Court of Appeals for the District of Columbia Circuit, Harry T. Edwards said, "The forensic science system in the United States has serious problems that can only be addressed by a national commitment to overhaul the current structure that supports the forensic science community.”

The report has called the Congress to set up a new federal agency, to be called the National Institute of Forensic Science or NIFS, to monitor and manage forensic science department in the United States. It has also made a dozen of other recommendations to strengthen forensic science labs.

Posted: 2/20/2009 3:19:00 PM

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Genetics May Help Fine-Tune Warfarin Dosage

From U.S. News & World Report:

A DNA test could make prescribing the widely used anticoagulant warfarin safer by predicting the lowest effective dose, a new study finds.

Because an effective dose of warfarin can vary as much as 10-fold from one person to the next, doctors start most people on a low dose and increase it until blood tests indicate the dose is correct. That process can take months.

For the study, which is published in the Feb. 19 issue of the New England Journal of Medicine, researchers collected demographic and genetic data on people at risk for stroke, heart disease and other problems related to blood clotting. The ideal doses of warfarin for these individuals had already been established by trial and error.

In addition, they looked at variants of two genes: CYP2C9, which affects how the liver activates and excretes warfarin, and VKORC1, which activates vitamin K, essential for blood clotting.

They used the data to create an algorithm that would predict the ideal dose of warfarin in a study of more than 4,000 people.

The researchers found that the algorithm predicted the ideal dose of warfarin better than other approaches.

Specifically, the algorithm's predictions were, on average, within about 8.5 milligrams of a person's ideal weekly dose. Demographic and clinical data alone predicted doses of about 10 milligrams off the ideal weekly dose, and a method that used a fixed daily dose, or about 35 milligrams a week, was off by an average of 13 milligrams, the researchers found.

"Warfarin has a very narrow therapeutic range," said co-author Teri Klein, a senior research scientist in genetics at Stanford. "Overdosing and underdosing of warfarin results in patients either being at much greater risk for excessive bleeding (overdosing) or clotting (underdosing)," she said.

"We found, based on this population, that 46 percent of the population would benefit by including their genotypes for these two genes," Klein said. "By including the genotypes along with clinical and demographic information, initial dosing is much closer to the ideal dose, thus limiting potential adverse events."

Altman said a trial now is needed to see if people who are prescribed warfarin based on genetic testing actually do better than those whose dosage is not determined with the aid of genetics.

Dr. Richard C. Becker, professor of medicine in the divisions of cardiology and hematology at Duke University School of Medicine, said that the researchers appear to be on the right track but that more testing is needed before the approach becomes standard practice.

Posted: 2/19/2009 12:47:00 PM

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Shingles 'risk' of arthritis drug

From BBC News:

Some popular treatments for rheumatoid arthritis could increase the risk of the painful condition shingles, a German study suggests.

Anti-TNF (anti-tumour necrosis factor alpha) therapy drugs can slow the progress of disease and help to reduce some of the worst symptoms.

But some of them may make patients more vulnerable to shingles, a skin disease which produces sore, itchy blisters.

Writing in JAMA, the authors advised patients on such drugs be monitored.

The team at the Rheumatism Research Centre in Berlin analysed data from more than 5,000 patients on different forms of treatment.

There were 86 outbreaks of shingles - triggered by the virus Herpes zoster - among 82 patients. Thirty-nine of these coincided with treatment with the anti-TNF drugs adalimumab and infliximab.

Etanercept, a protein therapy, and conventional disease-modifying anti-rheumatic drugs were associated with 23 and 24 cases respectively.

After adjusting for the age of the patient, the severity of their illness and their use of steroid hormone therapies, researchers found that the risk for patients on the anti-TNF programme almost doubled.

Although this was beneath the threshold of clinical significance, which would be an increase of more than double, the researchers, led by Dr Anja Strangfeld, said their findings suggested doctors should be on the look out for shingles in the patients they treat with these drugs.

Shingles is the reactivation of the virus infection that causes chickenpox. After a person has had the infection, usually as a child, the virus remains in their body and can return, usually after the age of 50.

A weakened immune system is thought to be one of the triggers, and it is suggested that this may be why anti-TNF drugs could have this effect.

Posted: 2/18/2009 10:15:00 AM

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Study: Tungsten causes leukemia symptoms in mice

From the Reno Gazette-Journal:

Laboratory mice developed leukemia-like blood symptoms after Arizona scientists exposed the rodents to tungsten at levels common in the air and water in Fallon and then exposed them to a common respiratory virus.

The experiments are part of research into the Fallon leukemia cluster that has sickened 17 children and killed three since 1997. The last case in the cluster was diagnosed in 2004.

Mark Witten and Paul Sheppard of the University of Arizona, who have been investigating childhood leukemia clusters in Fallon and Sierra Vista, Ariz., since 2002, exposed mice to tungsten and to a virus.

Four of the six mice have increased numbers of white blood cells, one of the primary indicators of leukemia, Witten said.

"This is the first time it's been shown that an element in nature, in this case tungsten, can possibly cause cancer," he said.

He said the mice will be humanely destroyed and their bone marrow will be analyzed to look for "blasts," abnormal white cells that are the telltale signs of leukemia. The bone marrow also will be checked for traces of tungsten, he said.

The scientists are scheduled to report their results at Experimental Biology 2009, an April 22 conference in New Orleans. The summary of the study was reviewed by a scientific panel before it was accepted for presentation. Cynthia Fastje, who conducted the experiments with Witten, is an author of the report.

Kennametal Inc., which has had a plant in Fallon since the 1960s and operates a refinery north of town, has used tungsten, cobalt and other metals to manufacture products. Previous studies have described the "heavy metals plant" as a "candidate source" of the airborne metal, though Kennametal hasn't been named in the reports.

In previous interviews, Kennametal officials said its plant meets or exceeds all air pollution laws and its presence in the community isn't related to the childhood cancer cluster.

Don Vetter, Kenametal spokesman in Reno, said Wednesday the firm can't comment because nothing has so far been published and the presentation hasn't been delivered.

Tungsten is a naturally occurring element used to make strong metal alloys. Microscopic amounts can be found in soil nearly everywhere in the West, but studies showed Fallon and Sierra Vista have abnormally high levels of the metal in their air. Sheppard and Witten's other Fallon studies have indicated the airborne particles are composed of processed tungsten, not natural tungsten ore.

Posted: 2/13/2009 9:36:00 AM

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FDA targets narcotic use

From USA Today:

The Food and Drug Administration announced Monday that it was stepping up efforts to reduce unsafe use of 24 narcotics products — methadone pills, fentanyl patches and extended-release pills containing morphine, oxymorphone and oxycodone, such as OxyContin.

"This is a very extensively used group of medications," said John Jenkins, director of the FDA's Office of New Drugs. In 2007, he said, U.S. pharmacies dispensed 21 million prescriptions for the 24 opioid products, used by 3.7 million Americans.

Despite label warnings and collaborations between the FDA and other federal agencies, misuse, abuse and accidental overdoses of the products have grown over the past decade, he said. The FDA is concerned about doctors prescribing the drugs inappropriately, to patients who don't have moderate to severe chronic pain, Jenkins said. For example, "we continue to see case reports where someone with a sprained ankle receives a fetanyl patch or extended-release opioid," which, when chewed instead of swallowed whole, releases a large dose.

In addition, non-medical use by adults is rising. Data released Monday by the Substance Abuse & Mental Health Services Administration showed that non-medical use of prescription painkillers in Americans 18-25 rose from 4.1% in 2002 to 4.6% in 2007. Over that same period, non-medical use rose to 1.6% from 1.3% in Americans 26 and older.

The 16 companies that make the 24 products received FDA letters Friday saying their drugs must have a "Risk Evaluation and Mitigation Strategy," or REMS. A 2007 law authorized the agency to require REMS "to ensure that the benefits of the drugs continue to outweigh the risks," the FDA said. It will meet with the makers March 3 and with patient advocates and other stakeholders in late spring or early summer, Jenkins said.

Posted: 2/10/2009 12:53:00 PM

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