Danish company pulls diabetes drugs from Greece over price cut

Danish pharmaceutical group Novo Nordisk said Saturday it was pulling 17 types of medication for treating diabetes from the Greek market following a government decree to lower prices of drugs.

“The products that are pulled from the market are the latest generation of insulin products in the pen system,” Mike Rulis, Novo Nordisk’s head of corporate communications, told AFP.

The company, the world’s largest producer of insulin to treat diabetes, said it will not stop selling the 17 products but insists on keeping their prices at the level before the Greek decree took effect on May 3, forcing it to lower prices by about 25 percent.

“That means wholesellers will no longer order these products, because they can only sell them to the pharmacies at a loss, because they will only be reimbursed at the minus 25 percent level,” Rulis said.

Novo Nordisk has however agreed to the price cut on its standard human insulin products, which diabetes patients take out of vials and inject with a syringe.

It will also make another product for diabetes sufferers, glucagon, available for free.

Rulis said about 50,000 people in Greece use the new generation products that the company will pull from the market, while another 40,000 use standard human insulin.

If Novo Nordisk complied with the 25 percent price cut on all products, its operations in Greece would become loss-making, Rulis said.

“The financial consequences for the company would be very significant,” he said, adding “a price lowering of this magnitude in Greece would automatically trigger price reductions in other countries.”

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For Depression, Phone Therapy May Be an Answer

When you’re depressed, do you need to meet a therapist in person? Maybe not, suggests a small new study, which finds that therapy by telephone is almost as effective as face-to-face.

Researchers at Brigham Young University had 30 people who were newly diagnosed with depression talk to a therapist by phone for 21 to 52 minutes. They did this instead of making eight visits to a clinic.

None of the participants got antidepressant medicine.

Six months later, 42 percent of the participants had recovered from depression. About 50 percent of patients recover from depression when face-to-face therapy is provided, the researchers said.

“Offering a phone or webcam option for psychotherapy does appear warranted from an efficacy point of view,” said study co-author Diane Spangler, a psychology professor, in a statement. “It’s more user-friendly — no commutes, more flexibility of place and time and has no side effects.”

But not everyone is willing to try phone therapy. A third of eligible participants declined it.

The study is published in the June issue of Behavior Therapy.

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FDA probes risks of HIV, prostate, other drugs

U.S. regulators are investigating potential risks from Abbott Laboratories Inc’s HIV drug Kaletra, GlaxoSmithKline Plc’s prostate drug Avodart and other medicines.

The Food and Drug Administration said on Monday it was probing reports of liver toxicity with patients who used Kaletra to prevent HIV infection after exposure to the AIDS virus.

The agency also said it was investigating cases of male breast cancer in patients treated with Avodart as well as Merck & Co’s prostate drug Proscar and baldness treatment Propecia.

The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The list released on Monday covered issues identified between October and December 2009.

Being on the list does not mean the FDA has concluded the drug causes the specific risk, the agency said.

Abbott spokeswoman Elizabeth Hoff said the company added information to Kaletra’s label last week noting that patients who took the drug to prevent HIV infection were among those who should undergo liver monitoring tests.

The label says some reported cases of liver dysfunction were serious. “However, a definitive causal relationship with Kaletra therapy has not been established,” the drug label says.

Merck spokeswoman Pam Eisele said the prescribing instructions for Proscar and Propecia already mention cases of male breast cancer seen in clinical trials. Both drugs contain the same active ingredient.

“A causal relationship has not been established,” she said.

Glaxo spokeswoman Sarah Alspach said the company evaluates all reported cases of breast cancer in men taking Avodart.

“Based on reports evaluated to date, there is not conclusive evidence of a causal association between Avodart and male breast cancer,” she said.

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EU says trade talks with India will not hit generic drugs

The European Union insisted Monday that a free-trade deal being negotiated between the trading bloc and India will not hurt the South Asian nation’s exports of “life-saving” generic drugs.

The assurance came after humanitarian medical group Medecins Sans Frontieres (MSF) said the free trade deal could mean people in developing nations no longer being able to have access to cheap generic drugs from India.

The EU’s ambassador to India said Brussels had no interest in halting the manufacture and export of generic drugs from India, known as the “pharmacy of the developing world”.

The agreement is not intended to limit India’s capacity “to produce and export life-saving (generic) medicines”, Daniele Smadja, head of the Delegation of the European Union in New Delhi, told reporters in the Indian capital.

Smadja said a leaked version draft provisions of part of a proposed free trade agreement between India and the EU covering generic drugs that had been highlighted by MSF was “not the text which will be in the agreement.”

The text will be “subject to discussions and negotiations”, she said.

India is the source of 80 percent of the AIDS medicines used in projects run by MSF, which says it fears the trade pact could deal a fatal blow to India’s status as the leading manufacturer and exporter of non-branded medicines.

The 27-member EU and India are aiming to conclude negotiations on a free trade agreement by late October when a summit meeting is planned, Smadja said.

India?s exports to the European Union, its largest trading partner, in 2008-09 are estimated at 39.35 billion dollars, while imports totalled 42.73 billion dollars.

“I am confident that with political will we will manage to find a mutually beneficial agreement,” the EU ambassador to India said.

The EU, which sees a free-trade deal with New Delhi as helping boost its presence in fast-growing Asia, and India, the world’s second most populous nation, launched talks on a free trade agreement in 2007.

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‘Healthy’ Pre-Diabetics Still Face Heart Disease Threat

People who are at high risk of developing diabetes and high blood pressure but don’t have symptoms yet may still be at higher risk for heart disease, a new study reports.

“Diabetes and hypertension have reached epidemic status, not only in the U.S., but across the globe,” Dr. Henry R. Black, president of the American Society of Hypertension, said in a society news release. “We are encouraged by research that sheds light on early indicators of cardiovascular disease, which may lead to better methods of predicting, and ultimately preventing, these devastating illnesses.”

In one study, researchers analyzed data on disease-free people who were examined between 1999 and 2006, and were found to be either prehypertensive — at high risk of developing high blood pressure — or prediabetic.

One in three seemingly healthy adults were deemed to be prehypertensive and one in four were deemed to be prediabetic. One in 10 fit in both categories; they tended to be overweight and were thought to be at especially high risk of heart disease or stroke, the study authors noted.

“We would like to propose that prehypertension (blood pressure above 120/80 mm Hg) and prediabetes (blood sugar of more than 100 mg/dL) occurring together should be a red flag for urgent further evaluation,” said study lead author Dr. Alok K. Gupta, assistant professor with the Louisiana State University System in Baton Rouge, in the news release.

The study findings are scheduled to be presented Monday at the American Society of Hypertension’s Annual Scientific Meeting and Exposition, held in New York City.

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