From Mesothelioma to Vioxx, from Viagra to Vitamins

Clinton Foundation announces bargained price on Generic AIDS drugs

Former President Bill Clinton announced yesterday that his foundation had negotiated deep price reductions for generic versions of costly, second-line AIDS drugs needed when the original medicines fail, as well as for less toxic, easier-to-use first-line medicines combined in a pill that can be taken once a day.

Standing next to Thailand’s health minister, Mr. Clinton also forcefully endorsed recent decisions by Thailand and Brazil to break patents held by American pharmaceutical companies that are charging prices Mr. Clinton described as exorbitant, but that drug company officials said were reasonable.

“No company will live or die because of high price premiums for AIDS drugs in middle-income countries, but patients may,” he said.

The new prices would halve the cost of the drugs for better-off developing countries in Latin America and Asia and cut prices by 25 percent in poor countries, which were already paying lower prices, the foundation said. The second-line medicines will be bought with more than $100 million raised by a group of countries led by France. The improved first-line therapies will largely be financed by the Global Fund to Fight AIDS, Tuberculosis and Malaria and other donors.

Second-line drugs have typically cost about 10 times as much as first-line therapies. Costs have ballooned in Brazil and Thailand, which began programs to provide universal access to AIDS treatment years before African countries did, as patients have developed resistance to generic first-line treatments and have moved to brand-name second-line drugs.

The Clinton Foundation’s willingness to buy the generic drugs from the Indian manufacturers Cipla and Matrix will give developing countries leverage in bargaining with American companies for lower prices on branded antiretroviral drugs and may embolden some to follow Brazil and Thailand in overriding patents, AIDS activists said.

But developing countries still have reason to worry about retaliation from drug companies and trade sanctions by the United States. This year, Abbott Laboratories, based in Illinois, withdrew new drugs, including those for high blood pressure and AIDS, that it had planned to introduce in Thailand until the override on Abbott’s patent on the second-line drug, Kaletra.

United States trade officials last week put Thailand on a watch list for countries inadequately safeguarding the intellectual property rights of American companies, noting the overriding of drug patents.

Tido von Shoen-Angerer, who leads the campaign by Doctors Without Borders for access to medicines, said he was unsure whether the recent developments would encourage developing countries to exercise their rights under international trade rules more freely to make or import generic drugs.

“There’s a strong chilling effect from the U.S. action,” he said.

Drug company officials yesterday strongly defended their policies of charging better-off developing countries more for AIDS drugs than they did for poor countries, as well as the role of patents, which give inventor companies a monopoly on the sale of a drug, in stimulating the development of new drugs.

Jennifer Smoter, a spokeswoman for Abbott, said patents were needed “to ensure innovation in the future” but declined to respond to Mr. Clinton’s comment that “Abbott has been almost alone in its hard-line position here over what I consider to be a life and death matter.”

Abbott had been charging $2,200 annually per patient for Kaletra in middle-income developing countries, which include India, China, Brazil and Ukraine. Last month, it dropped the price to $1,000. The foundation’s new price for the generic is $695.

Jeffrey L. Sturchio, a vice president at Merck in New Jersey, says his company strives to balance providing the broadest possible access to AIDS drugs while maintaining financial incentives to attract companies to conduct research and development on new drugs.

Brazil and Thailand have overridden Merck’s patent on the AIDS drug efavirenz, an ingredient of the new, improved first-line AIDS therapies. Merck had been charging Brazil $577 annually per patient, a price it agreed to drop to $400 a year after Brazil said it was considering overriding the patent. The Clinton Foundation’s new price for the generic drug is $164.

Labels: aids drugs at discount price, clinton foundation against aids, clinton foundation announces aids drugs, efavirenz, hpv drugs

Genetic variation linked to heart disease

A common genetic variation on chromosome 9p21 is linked to a substantial increase in risk of heart attack, according to a new international research study published in the latest edition of the Journal Science.

Investigators enrolled 4,587 patients over the last eight years, who suffered myocardial infarctions, along with 12,769 control individuals.

Researchers found individuals with the variation have a 1.64-fold greater risk of suffering a heart attack (myocardial infarction) and a 2.02-fold greater risk of suffering a heart attack early in life (before age 50 for men and before age 60 for women) than those without the variation.

The study uncovered the first common variant found to be consistently linked to substantial risk of heart attack. About 21 percent of individuals of European descent carry two copies of the genetic variation (one from each parent), found on chromosome 9p21.

The research project was led by the Icelandic genomics company deCODE Genetics, along with U.S. researchers at Emory University School of Medicine, Duke University, and the University of Pennsylvania.

Myocardial infarction is the death of heart tissue that results when the blood supply to the heart is cut off. It is the leading cause of death in the industrialized world. Nearly half of men and one-third of women who reach the age of 40 will suffer a heart attack in their lifetime.

Labels: chromosome 9p21, deCODE Genetics, genetics and heart disease, Myocardial infarction

Sorry folks, I'm takin a break, while I'm away on a conference to Boston. But please do check out the archives in this blog. They've got a ton of information on your favorite topics on your favorite blog.

So, dig into the archives. See ya Monday, May 7th.

Ciao....

Quote "This not only helps tell whether you have prostate cancer, but what kind of prostate cancer you have." Robert H. Getzenberg, Ph.D., Johns Hopkins University

New Blood Test For Prostate Cancer

An experimental blood test for prostate cancer seems to work better than the current PSA test — and can tell whether the cancer is spreading.

The new test looks for a protein called EPCA-2, early prostate cancer antigen 2. Unlike the PSA (prostate-specific antigen) protein on which the current PSA test is based, this protein isn't found in normal prostate cells. Instead, EPCA-2 occurs in relatively large amounts only in prostate cancer cells.

The test is being developed by Robert H. Getzenberg, Ph.D., director of urology research at Johns Hopkins University's Brady Urological Institute. Getzenberg began the work while still at the University of Pittsburgh; the test has been licensed to the Seattle biotech firm Onconome Inc.

"We wanted to find something that really identified people with prostate cancer and not people with enlarged or infected prostates," ."This is as close to cancer specific as we could find. We found it is very unique. It is 97 percent specific, meaning that if you test positive there's only a 3 percent chance you don't have prostate cancer."

Getzenberg has a financial interest in the test. But experts who do not stand to gain from the test agree that it has enormous potential.

Otis Brawley, M.D., chief of the solid tumor service at Emory University's Winship Cancer Institute, calls the test "important" and predicts it will be widely used.

Charles A. Coltman Jr., M.D., associate chairman for cancer control and prevention at San Antonio's Southwest Oncology Group, calls the findings "striking" and "remarkable," although he warns that the test has been tried out on only a small number of patients.

Ganesh Palapattu, M.D., assistant professor of urology at the University of Rochester, agrees that more studies must be done. But he tells WebMD that the test is a big step toward the "Holy Grail of prostate cancer detection: not so much identifying men with prostate cancer, but identifying men with prostate cancer who have aggressive disease."

"This not only helps tell whether you have prostate cancer, but what kind of prostate cancer you have," Getzenberg says.

Getzenberg and colleagues report early studies of the EPCA-2 test in the April issue of the journal Urology.

EPCA-2 Test Beats PSA

Nobody is entirely happy with the current PSA test for prostate cancer. A man without prostate cancer can have high PSA levels. A man with advanced prostate cancer may have very low PSA levels.

Getzenberg's team tried out the EPCA-2 test on blood samples from several different groups of people. Some were known to have early prostate cancer or late prostate cancer, and some had other kinds of cancer. Some had enlarged prostates, but not cancer. Some were women, who have no prostate gland. And some were healthy men with normal PSA levels.

Both in terms of detecting cancer when it was actually there (sensitivity), and in terms of not detecting cancer when it wasn't actually there (specificity), the EPCA-2 test beat the PSA test.

More importantly, it beat the PSA test in predicting whether prostate cancer already had spread outside the prostate gland. When that has happened, standard treatments for prostate cancer — radical prostatectomy (surgery to remove the prostate) and brachytherapy (tiny radioactive seeds implanted in the prostate) — fail to cure.

"I predict that within the next year, this test is going to be widely used to find the guy who has prostate cancer and who, if he got radical prostatectomy, would relapse very quickly," Brawley tells WebMD. "It is going to say to this guy, 'Skip the unnecessary surgery and get pelvic radiation and hormone treatment now.'"

Getzenberg says it will be at least two years before the test is "out on the street" with FDA approval. All of the experts who spoke to WebMD agree that large-scale screening tests will be needed before it's known exactly how well the test works.

"What we really need to know is how this test behaves in all comers, when we don't already know whether the men being tested have prostate cancer," Palapattu says. "It would also be important to identify men with high risk of prostate cancer vs. low risk of prostate cancer, and to test men after prostate surgery to see whether it can predict cancer recurrence."

When, and if, the EPCA-2 test is approved, men will still need better prostate cancer tests.

Labels: epca-2 test for prostrate cancer, new blood test for prostrate cancer, prostrate cancer treatments, psa test for prostrate cancer