http://news.sciencemag.org/scienceinsider/2011/09/white-house-boosts-transla
tional.html?ref=hp
The NIH and the Defense Advanced Research Projects Agency will each invest
as much as $70 million over five years on a chip to test compounds for
toxicity before they are administered to humans. The agencies will also
coordinate with the FDA, which could utilize the chip to accelerate the
drug-approval process. "If things are going to fail, you want them to fail
early," said NIH Director Francis Collins. "Now you'll be able to find out
much quicker if something isn't going to work." Meanwhile, the NIH is
searching for someone to lead its proposed National Center for Advancing
Translational Sciences.
Tuesday, September 20, 2011
Prostate Cancer Info Link Interesting Article
If you are among the people in America who agree with one or other of the following two statements, you need an immediate crash course in what approval of a new drug by the U.S. Food & Drug Administration (FDA) does actually mean:
FDA only approves drugs without serious side effects.
FDA only approves “extremely effective” drugs.
According to a recent survey conducted by Schwartz and Woloshin and just published in the Archives of Internal Medicine:
25 percent of 2,944 people surveyed did indeed believe that the FDA only approves drugs without any serious side effects.
39 percent of 2,944 people surveyed did indeed believe that the FDA only approves “extremely effective” drugs.
In fact, neither of these two things are true at all. So what is the truth?
In reality, FDA approval only implies that — after careful review — the agency has determined that “the benefits [of the approved agent] are judged to be greater than the harms. It doesn’t mean that they’re big and important,” said Woloshin in a statement to Reuters, which has also reported on this study.
Schwartz and Woloshin also assessed people’s perceptions about the relative value of newer and older medicines based on FDA approval. The two drugs used in this test actually had approximately equal efficacy and approximately the same side effects in the management of heartburn, but some 66 percent of those questioned picked the newer medication when asked to make a choice between the two.
In fact, in many cases, FDA approval is not based on direct comparisons of effectiveness and safety between drug X and drug Y, so there may be no good reasons to believe that one is any better or safer than the other. In the case of new cancer drugs, the FDA does try hard to encourage drug developers to carry out trials that compare a new drug to the “standard of care” at the time a new trial is being designed, but it is not always possible to do this, and events may overtake reality.
As an example, it would be nice to know whether MDV3100 is or is not safer or more effective than abiraterone acetate in the treatment of castration-resistant prostate cancer (CRPC). However, abiraterone acetate wasn’t approved at the time the Phase III trials of MDV3100 were being designed. At that time, the standard of care for any man with CRPC — metastatic or otherwise — was still chemotherapy with docetaxel + predisone. Unless either the survival benefit demonstrated by MDV3100 is a lot more or a lot less than 3.9 months compared to placebo, or the side effects of MDV3100 are a lot worse or a lot better than those exhibited by patients on abiraterone acetate compared to placebo, there will be no way to assess whether one drug is any “better” than the other. For very similar reasons, we have no idea of the relative merits of treating men with CRPC with either abiraterone acetate of sipuleucel-T.
The FDA does its best to ensure that important new drugs for conditions like prostate cancer are moved through the regulatory process in a timely manner. In recent years, they have become pretty successful at this. However, we are likely, over time, to discover than some of these new drugs have additional, and potentially significant, side effects that were simply not seen or reported in the relatively small numbers of patients who participate in the clinical trials that customarily lead to drug approval.
Here is a brief list of some very simple things that it is well worth understanding about what an FDA approval of a new drug actually does and does not mean:
FDA approval means that, on average, the benefits of using a drug outweigh the risks in a well-defined set of patients with a specific disorder.
FDA approval means that the FDA has worked closely with the drug developer to create detailed prescribing information for the new drug
The prescribing information for every drug includes
Information about what types of patients the drug is approved for
Information about the effectiveness of the drug in this set of patients
Information about the side effects of the drug when used in this set of patients
Warnings about serious adverse effects (up to and including death) associated with the use of the drug
Information about the recommended dose of the drug and how it should be given to or taken by patients
FDA approval of a drug never implies that
A drug is completely safe
A drug has no side effects
All the side effects of a drug have been discovered
A drug will necessarily be effective for you as an individual
On average, the benefits of using a drug will outweigh the risks if the drug is used to treat an unapproved condition
A drug is “better” than other drugs for the approved condition (unless it has been compared to another drug or drug in a “head-to-head” clinical
FDA only approves drugs without serious side effects.
FDA only approves “extremely effective” drugs.
According to a recent survey conducted by Schwartz and Woloshin and just published in the Archives of Internal Medicine:
25 percent of 2,944 people surveyed did indeed believe that the FDA only approves drugs without any serious side effects.
39 percent of 2,944 people surveyed did indeed believe that the FDA only approves “extremely effective” drugs.
In fact, neither of these two things are true at all. So what is the truth?
In reality, FDA approval only implies that — after careful review — the agency has determined that “the benefits [of the approved agent] are judged to be greater than the harms. It doesn’t mean that they’re big and important,” said Woloshin in a statement to Reuters, which has also reported on this study.
Schwartz and Woloshin also assessed people’s perceptions about the relative value of newer and older medicines based on FDA approval. The two drugs used in this test actually had approximately equal efficacy and approximately the same side effects in the management of heartburn, but some 66 percent of those questioned picked the newer medication when asked to make a choice between the two.
In fact, in many cases, FDA approval is not based on direct comparisons of effectiveness and safety between drug X and drug Y, so there may be no good reasons to believe that one is any better or safer than the other. In the case of new cancer drugs, the FDA does try hard to encourage drug developers to carry out trials that compare a new drug to the “standard of care” at the time a new trial is being designed, but it is not always possible to do this, and events may overtake reality.
As an example, it would be nice to know whether MDV3100 is or is not safer or more effective than abiraterone acetate in the treatment of castration-resistant prostate cancer (CRPC). However, abiraterone acetate wasn’t approved at the time the Phase III trials of MDV3100 were being designed. At that time, the standard of care for any man with CRPC — metastatic or otherwise — was still chemotherapy with docetaxel + predisone. Unless either the survival benefit demonstrated by MDV3100 is a lot more or a lot less than 3.9 months compared to placebo, or the side effects of MDV3100 are a lot worse or a lot better than those exhibited by patients on abiraterone acetate compared to placebo, there will be no way to assess whether one drug is any “better” than the other. For very similar reasons, we have no idea of the relative merits of treating men with CRPC with either abiraterone acetate of sipuleucel-T.
The FDA does its best to ensure that important new drugs for conditions like prostate cancer are moved through the regulatory process in a timely manner. In recent years, they have become pretty successful at this. However, we are likely, over time, to discover than some of these new drugs have additional, and potentially significant, side effects that were simply not seen or reported in the relatively small numbers of patients who participate in the clinical trials that customarily lead to drug approval.
Here is a brief list of some very simple things that it is well worth understanding about what an FDA approval of a new drug actually does and does not mean:
FDA approval means that, on average, the benefits of using a drug outweigh the risks in a well-defined set of patients with a specific disorder.
FDA approval means that the FDA has worked closely with the drug developer to create detailed prescribing information for the new drug
The prescribing information for every drug includes
Information about what types of patients the drug is approved for
Information about the effectiveness of the drug in this set of patients
Information about the side effects of the drug when used in this set of patients
Warnings about serious adverse effects (up to and including death) associated with the use of the drug
Information about the recommended dose of the drug and how it should be given to or taken by patients
FDA approval of a drug never implies that
A drug is completely safe
A drug has no side effects
All the side effects of a drug have been discovered
A drug will necessarily be effective for you as an individual
On average, the benefits of using a drug will outweigh the risks if the drug is used to treat an unapproved condition
A drug is “better” than other drugs for the approved condition (unless it has been compared to another drug or drug in a “head-to-head” clinical
Tuesday, September 6, 2011
Family Physician Prostate Cancer Screening
Prostate Cancer: Who Should Be Treated?
Am Fam Physician. 2011 Aug 15;84(4):424.
See related article on prostate cancer treatments.
What are the pros and cons of treating prostate cancer?
Prostate cancer is usually found in the early stages, when treatment can cure it. Some men have more aggressive cancer that spreads quickly; treatment can be life-saving in these cases. However, treatment can also cause urinary, sexual, and bowel problems.
Why is treatment not recommended for some people?
In most men, prostate cancer grows so slowly that it will not lead to death within 10 years, even if the cancer is not treated. Prostate cancer is usually found late in life, so men who are expected to live less than 10 years and who have a slow-growing cancer will probably not benefit from treatment.
How do I know how aggressive my prostate cancer is?
Your doctor will do a biopsy and a blood test to find out your risk. These tests will also tell you whether the cancer has spread outside the prostate. Treatment is recommended if the risk of the cancer spreading is high, or if it has already spread.
What treatment options are there?
The two most common options are surgery and radiation therapy. Your doctor can help you choose which treatment is best for you. After either treatment, about two out of three patients have problems getting an erection. However, many of these patients usually had this problem before the cancer was found. Surgery is more likely to cause urinary problems, and radiation therapy is more likely to cause bowel problems. One type of radiation therapy, called brachytherapy (BRAY-kee-THER-uh-pee), has fewer side effects. In brachytherapy, radioactive seeds are put inside the prostate gland.
What happens if I choose not to treat my prostate cancer?
If you choose not to treat your cancer, your doctor will have you follow a program called active surveillance. In this program, you will have blood tests and biopsies done on a regular basis. If these tests find that your risk has increased, your doctor may recommend that you consider treatment.
This handout is provided to you by your family doctor and the American Academy of Family Physicians. Other health-related information is available from the AAFP online at http://familydoctor.org.
This information provides a general overview and may not apply to everyone. Talk to your family doctor to find out if this information applies to you and to get more information on this subject.
Copyright © 2011 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.
AFP Home | About Us | Contact Us | Subscribe | AFP by E-Mail | Permissions
About Online Access | Employment Opportunities
Information for: Authors | Advertisers
Am Fam Physician. 2011 Aug 15;84(4):424.
See related article on prostate cancer treatments.
What are the pros and cons of treating prostate cancer?
Prostate cancer is usually found in the early stages, when treatment can cure it. Some men have more aggressive cancer that spreads quickly; treatment can be life-saving in these cases. However, treatment can also cause urinary, sexual, and bowel problems.
Why is treatment not recommended for some people?
In most men, prostate cancer grows so slowly that it will not lead to death within 10 years, even if the cancer is not treated. Prostate cancer is usually found late in life, so men who are expected to live less than 10 years and who have a slow-growing cancer will probably not benefit from treatment.
How do I know how aggressive my prostate cancer is?
Your doctor will do a biopsy and a blood test to find out your risk. These tests will also tell you whether the cancer has spread outside the prostate. Treatment is recommended if the risk of the cancer spreading is high, or if it has already spread.
What treatment options are there?
The two most common options are surgery and radiation therapy. Your doctor can help you choose which treatment is best for you. After either treatment, about two out of three patients have problems getting an erection. However, many of these patients usually had this problem before the cancer was found. Surgery is more likely to cause urinary problems, and radiation therapy is more likely to cause bowel problems. One type of radiation therapy, called brachytherapy (BRAY-kee-THER-uh-pee), has fewer side effects. In brachytherapy, radioactive seeds are put inside the prostate gland.
What happens if I choose not to treat my prostate cancer?
If you choose not to treat your cancer, your doctor will have you follow a program called active surveillance. In this program, you will have blood tests and biopsies done on a regular basis. If these tests find that your risk has increased, your doctor may recommend that you consider treatment.
This handout is provided to you by your family doctor and the American Academy of Family Physicians. Other health-related information is available from the AAFP online at http://familydoctor.org.
This information provides a general overview and may not apply to everyone. Talk to your family doctor to find out if this information applies to you and to get more information on this subject.
Copyright © 2011 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.
AFP Home | About Us | Contact Us | Subscribe | AFP by E-Mail | Permissions
About Online Access | Employment Opportunities
Information for: Authors | Advertisers
PCa Guidance to Family Doctors
The August 15 issue of American Family Physician — supposedly one of the most widely read medical journals in America — carried an article by Mohan and Schellhammer entitled “Treatment options for localized prostate cancer.” Unfortunately the full text of this article is not available on line for the average reader.
In their article, Mohan (a family physician) and Schellhammer (a urologic oncologist who is himself a prostate cancer patient with progressive disease) offer family doctors rather more than a standard review of the diagnosis and treatment of prostate cancer, and it is the first review of prostate cancer to appear in American Family Physician since 2005. To that extent, it should be seen as a key overview on the subject of prostate cancer for the primary care community.
The article makes a number of evidence-based key points about the treatment of localized prostate cancer for the family practitioner, as follows:
Treatment of localized prostate cancer is unlikely to improve the survival of [most] men with low- and very low-risk disease and all such active interventions have potentially negative effects on health-related quality 0f life.
Despite this information, some 70 to 90 percent of men with localized prostate cancer choose an interventional treatment shortly after a positive biopsy.
More than 50 percent of such patients significantly over-estimate the survival benefit of treatment.
Treatment of localized prostate cancer should normally be recommended for higher-risk patients.
Risk level can be estimated based on cancer stage and grade, PSA level, and comorbidity-adjusted life expectancy (CALE).
Patients can be counseled that surgery and external beam radiation therapy are almost equal in efficacy for the treatment of localized prostate cancer.
Brachytherapy is an appropriate form of monotherapy in low-risk, localized prostate cancer.
Active surveillance is a reasonable management option for low- and very low-risk, localized prostate cancer.
The article also includes a series of tools that may be useful to primary care physicians and their patients in assessing risk and the appropriateness of differing forms of treatment, including:
A questionnaire to assess patient understanding of the benefits and risks of different treatment options.
A simplified algorithm (derived from the prostate cancer guidelines of the National Comprehensive Cancer Center Network) that can be used to aid selection of appropriate management of localized prostate cancer
A table to assist in assessment of a patient’s Charlson comorbidity index (CCI)
A table to assist in assessment of a patient’s comorbidity-adjusted life expectancy (CALE)
A table summarizing expected adverse effects at 2 years after treatment for localized prostate cancer
The Klotz (Canadian) protocol for active surveillance of men with localized prostate cancer (including indications for interventional treatment)
The article is supplemented by a handout for family physicians to use with their patients entitled “Prostate Cancer: Who Should Be Treated?” The full text of this brief handout is available on line.
Support group leaders and other prostate cancer educators are encouraged to ask the assistance of their family physicians or their local medical librarian in obtaining a copy of this article for their personal use.
It is inevitable that an article like this will not meet the approval of everyone in the prostate cancer community. It is an easy article to “pick holes in” if one is of a mind to do so. However, even with such limitations, what this article does do is to provide a series of tools and sound general information that will help the family practitioner to become more involved in the provision of appropriate guidance to patients diagnosed with prostate cancer — and particularly those patients of 60 to 80 years of age who comprise a significant majority of those being diagnosed with localized, low-risk prostate cancer today.
In their article, Mohan (a family physician) and Schellhammer (a urologic oncologist who is himself a prostate cancer patient with progressive disease) offer family doctors rather more than a standard review of the diagnosis and treatment of prostate cancer, and it is the first review of prostate cancer to appear in American Family Physician since 2005. To that extent, it should be seen as a key overview on the subject of prostate cancer for the primary care community.
The article makes a number of evidence-based key points about the treatment of localized prostate cancer for the family practitioner, as follows:
Treatment of localized prostate cancer is unlikely to improve the survival of [most] men with low- and very low-risk disease and all such active interventions have potentially negative effects on health-related quality 0f life.
Despite this information, some 70 to 90 percent of men with localized prostate cancer choose an interventional treatment shortly after a positive biopsy.
More than 50 percent of such patients significantly over-estimate the survival benefit of treatment.
Treatment of localized prostate cancer should normally be recommended for higher-risk patients.
Risk level can be estimated based on cancer stage and grade, PSA level, and comorbidity-adjusted life expectancy (CALE).
Patients can be counseled that surgery and external beam radiation therapy are almost equal in efficacy for the treatment of localized prostate cancer.
Brachytherapy is an appropriate form of monotherapy in low-risk, localized prostate cancer.
Active surveillance is a reasonable management option for low- and very low-risk, localized prostate cancer.
The article also includes a series of tools that may be useful to primary care physicians and their patients in assessing risk and the appropriateness of differing forms of treatment, including:
A questionnaire to assess patient understanding of the benefits and risks of different treatment options.
A simplified algorithm (derived from the prostate cancer guidelines of the National Comprehensive Cancer Center Network) that can be used to aid selection of appropriate management of localized prostate cancer
A table to assist in assessment of a patient’s Charlson comorbidity index (CCI)
A table to assist in assessment of a patient’s comorbidity-adjusted life expectancy (CALE)
A table summarizing expected adverse effects at 2 years after treatment for localized prostate cancer
The Klotz (Canadian) protocol for active surveillance of men with localized prostate cancer (including indications for interventional treatment)
The article is supplemented by a handout for family physicians to use with their patients entitled “Prostate Cancer: Who Should Be Treated?” The full text of this brief handout is available on line.
Support group leaders and other prostate cancer educators are encouraged to ask the assistance of their family physicians or their local medical librarian in obtaining a copy of this article for their personal use.
It is inevitable that an article like this will not meet the approval of everyone in the prostate cancer community. It is an easy article to “pick holes in” if one is of a mind to do so. However, even with such limitations, what this article does do is to provide a series of tools and sound general information that will help the family practitioner to become more involved in the provision of appropriate guidance to patients diagnosed with prostate cancer — and particularly those patients of 60 to 80 years of age who comprise a significant majority of those being diagnosed with localized, low-risk prostate cancer today.
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