PHARMACY

Outgoing GSK chief speaks on FDA approvals

BY Drew Buono

LONDON GlaxoSmithKline chief executive officer Jean-Pierre Garnier recently said that he does not foresee the Food and Drug Administration softening its position on drug approvals, according to published reports.

Garnier, who will be stepping down from the company next week at its annual meeting, said, “This is not a pendulum, society wants to avoid risk. We have to tease out the rare side effects earlier.”

Garnier added that the FDA has raised the bar and companies must adapt by shifting drug development priorities and conducting trials on targeted sub-populations to better realize rare side effects prior to regulatory submission.

Other senior industry personnel suggest the U.S. election has had a strong impact on the FDA’s position on new drugs and Garnier believes “the market will get reconstituted” with a new focus on so-called “progressive blockbusters,” which will ultimately reduce drug development costs by eliminating false negative results sooner.

In regard to his stepping down, Garnier confessed in an interview with the Financial Times that he wishes he had done things differently with GSK’s diabetes drug Avandia, in terms of releasing data earlier on about the risks of the drug to increase the risk of a heart attack.

In April, the FDA issued a warning to the company for not reporting safety results on Avandia. Avandia received the prominent, “Black Box” warning label last year and the FDA said that between 2001 and 2007 GSK neglected to update the agency on over 10 ongoing studies of Avandia, as required by regulations. The FDA acknowledges that information from those studies was included and disclosed in other notices to the government; however, the FDA categorizes the omissions as “serious,” saying that the omissions “may be symptomatic of underlying post-market reporting failures.”

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Drug producers give to help disaster victims

BY Drew Buono

NEW YORK Drug makers all over the world are working with international relief groups to send cash and medical supplies to victims of the cyclone in Myanmar and the earthquake in China, according to the Associated Press.

Among the donations:

  • Merck is giving about $500,000 in cash for Chinese victims, including two-to-one matches of donations from U.S. employees, plus $500,000 worth of antibiotics, heart medicines and vaccines, including shots to prevent infectious diseases.
  • Pfizer has given about $700,000 in cash and another $700,000 worth of medical products to earthquake victims in China, and has employees volunteering with the Red Cross there. Employees have given another $128,000 for China, which Pfizer is matching.
  • Abbott Laboratories is giving $250,000 for aid in Myanmar and is sending about $250,000 worth of adult and pediatric antibiotics and vitamins there, some of which arrived late last week; in China, it’s giving $1 million, roughly half cash and half in antibiotics and adult and pediatric nutrition products.
  • Baxter International has given $150,000 to help victims in Myanmar and is preparing to supply hundreds of thousands of intravenous solutions to hard-hit areas there.
  • Johnson & Johnson has given cash donations, consumer health care products and medicines to the Red Cross Society of China and plans to give cash to groups working in Myanmar.
  • Bristol-Myers Squibb is donating at least $500,000, mostly for China, where it also is sending 10,000 one-week supplies of antibiotics, infant and child nutritional products, and employee donations of blankets, clothing and camping equipment.
  • GlaxoSmithKline has given about $1.4 million for China and $100,000 for Myanmar.
  • Roche has sent 53,000 doses of an antibiotic to the Sichuan province.
  • Wyeth has donated antibiotics, infant formula, Centrum vitamins and an undisclosed amount of cash to China.
  • Eli Lilly is sending $300,000 in cash and $800,000 worth of medicines, mainly antibiotics, most of it to groups operating in China. It may later send insulin and mental health medicines.

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Research links ED and diabetes with later heart conditions

BY Drew Buono

WASHINGTON According to new findings in the Journal of the American College of Cardiology, men with type 2 diabetes who have problems maintaining an erection may foretell heart trouble, as reported by Reuters.

In one study, Italian researchers found that among 291 men with type 2 diabetes, those who also had erectile dysfuncion had twice the risk of suffering a heart attack, stroke or other cardiovascular complication over the next four years.

At the start of the study, all of the men had had evidence of “silent” heart disease—meaning they had plaque buildup in their arteries on imaging tests, but no heart disease symptoms, such as chest pain. Having ED seemed to pinpoint those men who were at particular risk of a complication. There was some good news though: Taking cholesterol-lowering statins appeared to reduce the risks associated with ED by one-third, according to the researchers.

In the second study, Hong Kong researchers found that among diabetic men with no indications of heart disease at the outset, those with ED were 58 percent more likely to die of heart disease, or have a heart attack or other non-fatal cardiac “event.”

“Erectile dysfunction is an important warning sign of future adverse heart events or even death,” study chief Peter Chun-Yip Tong, of the Chinese University of Hong Kong, told Reuters Health. The main reason, he explained, is that ED is an early manifestation of the blood vessel damage caused by diabetes and other risk factors for heart disease, such as high blood pressure.

Tong recommended that all men with diabetes tell their doctors if they begin to have problems getting or maintaining an erection. They can then have a comprehensive assessment of their cardiovascular risk factors, such as measurements of their blood pressure, cholesterol, waist size and kidney function, and work on getting those under control.

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