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The popular hair-growth drug finasteride, taken by millions of balding men, artificially lowers the results of the prostate-specific antigen (PSA) test, the standard screening test for prostate cancer, a multicenter study has found.

The study, involving 308 men ranging in age from 40 to 60 years old, is available online in the British medical journal The Lancet and is scheduled to be published after Jan. 1, 2007. The study calls for new clinical guidelines for primary-care physicians, dermatologists and urologists to account for the role of finasteride, known as Propecia when used for hair loss, while evaluating PSA results.

"It's not universally known that finasteride lowers PSA levels in younger men who take it for hair growth," said Dr. Claus Roehrborn, chairman of urology at UT Southwestern Medical Center and co-principal investigator of The Lancet study, along with Dr. Anthony D'Amico of Brigham and Women's Hospital and Dana-Farber Cancer Institute in Boston. "It is important for physicians to know that many young men take Propecia and that their PSA level is lowered artificially. Doctors need to adjust the PSA interpretation by multiplying it times two for these men."

Finasteride was initially developed in the 1990s for the treatment of benign prostatic hyperplasia (BPH), better known as enlarged-prostate disease, and was first approved by the U.S. Food and Drug Administration for this use. Patients with BPH must strain to pass urine and feel the urge to urinate frequently. BPH can lead to the inability to urinate and urinary tract infection.

In 1997 the FDA approved finasteride for the treatment of male-pattern baldness. While Propecia is administered at 1 milligram per day, patients who take the finasteride drug Proscar for BPH get a five times higher dosage, 5 mg per day.

"The impact of finasteride on PSA levels is significant," said Dr. Roehrborn. "This needs to be realized by all internists, family-care doctors, dermatologists - anybody who writes prescriptions for male-pattern hair loss."

Researchers have known for years that the same testosterone metabolism responsible for prostate growth also causes male-pattern baldness (called androgenic alopecia), Dr. Roehrborn said. Both BPH and male-pattern hair loss have to do with the male hormone testosterone, which is being converted to dihydrotestosterone (DHT) by an enzyme named 5-alpha reductase. DHT activates the genes responsible for the development of male-pattern hair loss. Finasteride interferes with this process by blocking 5-alpha reductase and preventing the conversion of testosterone to DHT.

The data in The Lancet study were collected by Dr. Roehrborn from 1998 to 2000 in cooperation with medical centers in Arizona, Colorado, Connecticut, Georgia, Indiana, Louisiana, Minnesota, New York, North Carolina, Oregon, Texas and Virginia.

The data in The Lancet study are derived from a study Dr. Roehrborn conducted with Merck & Co., Inc. in 2000. Dr. Roehrborn, discussing the reasons to publish this report now, said: "The data are published now out of recognition that there was an acknowledged gap in the primary-care community about the impact of Propecia on PSA levels. When doctors ask for their patients' medical history, they need to ask if they have taken any drugs for hair loss, and the doctors need to multiply the PSA readings by two."

The current study also was funded by Merck & Co., Inc.

About UT Southwestern Medical Center
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members - including four active Nobel Prize winners, more than any other medical school in the world - are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.
UT Southwestern Medical Center
United States
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The popular hair-growth drug finasteride, taken by millions of balding men, artificially lowers the results of the prostate-specific antigen (PSA) test, the standard screening test for prostate cancer, a multicenter study has found.

The study, involving 308 men ranging in age from 40 to 60 years old, is available online in the British medical journal The Lancet and is scheduled to be published after Jan. 1, 2007. The study calls for new clinical guidelines for primary-care physicians, dermatologists and urologists to account for the role of finasteride, known as Propecia when used for hair loss, while evaluating PSA results.

"It's not universally known that finasteride lowers PSA levels in younger men who take it for hair growth," said Dr. Claus Roehrborn, chairman of urology at UT Southwestern Medical Center and co-principal investigator of The Lancet study, along with Dr. Anthony D'Amico of Brigham and Women's Hospital and Dana-Farber Cancer Institute in Boston. "It is important for physicians to know that many young men take Propecia and that their PSA level is lowered artificially. Doctors need to adjust the PSA interpretation by multiplying it times two for these men."

Finasteride was initially developed in the 1990s for the treatment of benign prostatic hyperplasia (BPH), better known as enlarged-prostate disease, and was first approved by the U.S. Food and Drug Administration for this use. Patients with BPH must strain to pass urine and feel the urge to urinate frequently. BPH can lead to the inability to urinate and urinary tract infection.

In 1997 the FDA approved finasteride for the treatment of male-pattern baldness. While Propecia is administered at 1 milligram per day, patients who take the finasteride drug Proscar for BPH get a five times higher dosage, 5 mg per day.

"The impact of finasteride on PSA levels is significant," said Dr. Roehrborn. "This needs to be realized by all internists, family-care doctors, dermatologists - anybody who writes prescriptions for male-pattern hair loss."

Researchers have known for years that the same testosterone metabolism responsible for prostate growth also causes male-pattern baldness (called androgenic alopecia), Dr. Roehrborn said. Both BPH and male-pattern hair loss have to do with the male hormone testosterone, which is being converted to dihydrotestosterone (DHT) by an enzyme named 5-alpha reductase. DHT activates the genes responsible for the development of male-pattern hair loss. Finasteride interferes with this process by blocking 5-alpha reductase and preventing the conversion of testosterone to DHT.

The data in The Lancet study were collected by Dr. Roehrborn from 1998 to 2000 in cooperation with medical centers in Arizona, Colorado, Connecticut, Georgia, Indiana, Louisiana, Minnesota, New York, North Carolina, Oregon, Texas and Virginia.

The data in The Lancet study are derived from a study Dr. Roehrborn conducted with Merck & Co., Inc. in 2000. Dr. Roehrborn, discussing the reasons to publish this report now, said: "The data are published now out of recognition that there was an acknowledged gap in the primary-care community about the impact of Propecia on PSA levels. When doctors ask for their patients' medical history, they need to ask if they have taken any drugs for hair loss, and the doctors need to multiply the PSA readings by two."

The current study also was funded by Merck & Co., Inc.

About UT Southwestern Medical Center
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members - including four active Nobel Prize winners, more than any other medical school in the world - are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.
UT Southwestern Medical Center
United States
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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

UCLA researchers have found that Viagra may help patients with idiopathic pulmonary fibrosis, an incurable disease characterized by progressive scarring in the lungs, which often leads to a lung transplant.

Published in the March issue of the journal Chest, the research shows that more than half of the patients treated with Viagra, also known medically as Sildenafil, improved their walking distance by at least 20 percent during a standard test to measure lung function.

"Over five million worldwide suffer from this devastating disease, so we are hopeful that this drug may prove an effective therapy for pulmonary fibrosis," said the study's principal investigator, Dr. David A. Zisman, medical director of UCLA's Interstitial Lung Disease Program and assistant professor of pulmonary and critical care medicine at the David Geffen School of Medicine at UCLA.

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###

Other authors include: Dr. Harold R. Collard, department of medicine, San Francisco General Hospital, University of California, San Francisco; Kevin J. Anstrom, Ph.D., Duke Clinical Research Institute, Duke University; and Dr. Marvin I. Schwarz, department of medicine, University of Colorado Health Sciences Center.

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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
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urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

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On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

On Friday, the first day after Merck's loss of patent exclusivity for the statin Zocor, FDA approved three generic versions of the drug, the Wall Street Journal reports. Teva Pharmaceutical Industries and Ranbaxy Pharmaceuticals for the next 180 days will have exclusive rights to sell generic Zocor, generically known as simvastatin. Teva will sell 5-, 10-, 20- and 40-milligram versions, while Ranbaxy will sell an 80-milligram pill. The generic versions are available at a price that is about 30% less than Zocor's. In addition, Dr. Reddy's Laboratories will sell all five dosages of simvastatin under an agreement with Merck to be the authorized generic manufacturer of the drug. FDA's decision came hours after U.S. District Judge Royce Lamberth denied a motion by Sandoz, Novartis' generic drug unit, to delay the agency's approval of generic versions. Lamberth said the delay could damage the finances of Teva and Ranbaxy and could restrict the public's access to affordable drugs (Won Tesoriero/Zhang, Wall Street Jo
urnal, 6/24). FDA estimated that generic versions of Zocor and other generic drugs approved this week -- versions of baldness drug Propecia, prostate drug Proscar and epilepsy treatment Lamictal -- could result in $1 billion per year in savings. Rob Seidman, chief pharmacy officer for WellPoint, said 12 million Medicare Part D beneficiaries who use statins could generate $8.2 billion in savings per year if they switched to generic versions (CQ HealthBeat, 6/23).

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The popular hair-growth drug finasteride, taken by millions of balding men, artificially lowers the results of the prostate-specific antigen (PSA) test, the standard screening test for prostate cancer, a multicenter study has found.

The study, involving 308 men ranging in age from 40 to 60 years old, is available online in the British medical journal The Lancet and is scheduled to be published after Jan. 1, 2007. The study calls for new clinical guidelines for primary-care physicians, dermatologists and urologists to account for the role of finasteride, known as Propecia when used for hair loss, while evaluating PSA results.

"It's not universally known that finasteride lowers PSA levels in younger men who take it for hair growth," said Dr. Claus Roehrborn, chairman of urology at UT Southwestern Medical Center and co-principal investigator of The Lancet study, along with Dr. Anthony D'Amico of Brigham and Women's Hospital and Dana-Farber Cancer Institute in Boston. "It is important for physicians to know that many young men take Propecia and that their PSA level is lowered artificially. Doctors need to adjust the PSA interpretation by multiplying it times two for these men."

Finasteride was initially developed in the 1990s for the treatment of benign prostatic hyperplasia (BPH), better known as enlarged-prostate disease, and was first approved by the U.S. Food and Drug Administration for this use. Patients with BPH must strain to pass urine and feel the urge to urinate frequently. BPH can lead to the inability to urinate and urinary tract infection.

In 1997 the FDA approved finasteride for the treatment of male-pattern baldness. While Propecia is administered at 1 milligram per day, patients who take the finasteride drug Proscar for BPH get a five times higher dosage, 5 mg per day.

"The impact of finasteride on PSA levels is significant," said Dr. Roehrborn. "This needs to be realized by all internists, family-care doctors, dermatologists - anybody who writes prescriptions for male-pattern hair loss."

Researchers have known for years that the same testosterone metabolism responsible for prostate growth also causes male-pattern baldness (called androgenic alopecia), Dr. Roehrborn said. Both BPH and male-pattern hair loss have to do with the male hormone testosterone, which is being converted to dihydrotestosterone (DHT) by an enzyme named 5-alpha reductase. DHT activates the genes responsible for the development of male-pattern hair loss. Finasteride interferes with this process by blocking 5-alpha reductase and preventing the conversion of testosterone to DHT.

The data in The Lancet study were collected by Dr. Roehrborn from 1998 to 2000 in cooperation with medical centers in Arizona, Colorado, Connecticut, Georgia, Indiana, Louisiana, Minnesota, New York, North Carolina, Oregon, Texas and Virginia.

The data in The Lancet study are derived from a study Dr. Roehrborn conducted with Merck & Co., Inc. in 2000. Dr. Roehrborn, discussing the reasons to publish this report now, said: "The data are published now out of recognition that there was an acknowledged gap in the primary-care community about the impact of Propecia on PSA levels. When doctors ask for their patients' medical history, they need to ask if they have taken any drugs for hair loss, and the doctors need to multiply the PSA readings by two."

The current study also was funded by Merck & Co., Inc.

About UT Southwestern Medical Center
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members - including four active Nobel Prize winners, more than any other medical school in the world - are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.
UT Southwestern Medical Center
United States
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