Katherine Ellen Foley, Quartz: December 1, 2016
Late on Nov. 30, the US House of Representatives voted in sweeping favor across both sides of the aisle (392-26) on a $6.8 billion medical research bill. It’s expected to pass in the Senate, and it has support from the Obama administration.
The 21st Century Cures Act is great for medical research.[…]
All of this medical research spending, though, came with a regulatory compromise. Tucked in the folds of the bill were a number of new laws that allow the US Food and Drug Administration (FDA) to speed up the approval process for a range of treatments.
For example, the Cures Act allows for the expedited approval of new uses of drugs that had been approved previously for other conditions with just anecdotal case studies providing evidence that they work, instead of the usual randomized clinical trials. On the one hand, this means that treatments could reach patients more quickly, and save more lives. But on the other, it means that patients could be exposed to therapies whose risks aren’t completely understood.
There’s also a section of the Act that “expedite[s] the development and availability of treatments for serious or life-threatening bacterial or fungal infections in patients with unmet needs.” That sounds great in theory, but in practice, these drugs might be approved for use in specific patient populations without ever being tested in those people.
According to NPR, some 1,445 lobbyists from 400 organizations worked to sway lawmakers on this bill. Over 1,300 were from groups in favor of the bill, including deep-pocketed pharmaceutical companies in favor of the expedited approval process.“It really is a David and Goliath issue of where the money is,” Diana Zuckerman, the president of the nonprofit National Center for Health Research (which did not lobby for the bill), told NPR.
The Act will go to the Senate next week, where it is expected to pass. Notably, though, Democratic senators Elizabeth Warren from Massachusetts and Bernie Sanders from Vermont have vocally opposed it because of the softened regulations. On Nov. 28, Warren called the bill “extortion,” implying the benefits to the patients with additional medical research would be greatly outweighed by the risks of diminished regulation. The same week, Sanders said in a statement, “This is a bad bill which should not be passed in its current form. It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts.”
Read original posting here.
Shayla Love, STAT News: September 28, 2015
Is the FDA ’s approval process broken? […] Here are some excerpts of the conversation, edited for clarity.
Let me start off by asking: What do you think needs to be improved in the FDA approval process?
Zuckerman: I am increasingly concerned when the standards and criteria for what’s safe and what’s effective is moving more from the pre-market stage, before approval decisions are made, to the post-market stage. More drugs and devices are being approved on a basis of preliminary data, smaller samples, shorter time frames, and sometimes lacking control groups, as what recently happened with Duchenne muscular dystrophy. When that happens, it has a chilling effect on those who are trying to develop treatments and cures. Why would a company spend all of its energy working to do the best possible research if they can get an approval based on a shorter-term study, less definitive data, as long as they encourage patient groups to advocate and lobby for them?
What about the notion that patients and parents living with the disease are really the only ones who can understand what that’s like, and they should be in a position to assess the benefit and risk?
Zuckerman: I think patient perspectives absolutely should be factored in. And they should be factored in at every level. It’s not just important for patients who are wanting a treatment, it’s also equally important for the patients who get harmed. There are some folks in this room who have been harmed by unsafe medical products. They feel like FDA doesn’t listen to them. It’s really important to listen to patients, both the patients who can talk about the benefits of the drugs, or devices, but also the patients who can talk about the risks and the complications.
Going forward, why wouldn’t we be concerned that other companies won’t be emboldened to try and put an application in, and then force the issue? What we saw with this Duchenne episode is that when you have an effective pressure campaign, that can have an effect. And I’m not saying that’s necessarily a bad thing, that introduces a very human element into the discussion, and it can provide additional information.
Zuckerman: I want to get into the specifics of why this particular decision concerned us so much. The scientists all said this drug isn’t proven to work, we don’t know if it works, and therefore it doesn’t meet the legal standards that FDA is supposed to use to make a drug approval decision.
The company said they didn’t have a control group because it would be unethical to have a control group. That is a very frightening statement. If you think that it is not ethical to have a control group to study a drug that you don’t know whether it works or not, then you will never be able to find out if the drug works. You have to have a control group, particularly if you have a small sample like that.
Another big issue is the company announced the same day of the approval that this drug is going to cost $300,000 a year. This is a drug that has to be taken every year for the rest of these boy’s lives. It’s not a cure, it’s management. Now, these patients who have been getting this drug, presumably, for free as part of a clinical trial will somehow have to come up with $300,000 a year to continue to get the drug. I don’t know if insurance companies are going to pay for it, considering that the data show there’s not evidence that it works.
To see the original article, click here
Jay W. Bell Isle, Legal Reader: June 28, 2016
Brandel France De Bravo, MPH, Sarah Miller, Jessica Becker, and Laura Gottschalk, PhD, Cancer Prevention & Treatment Fund
Electronic cigarettes, or e-cigarettes, are being marketed as the “safe” new alternative to conventional cigarettes. But are e-cigarettes safe? What does the FDA think about them? Are e-cigarettes going to reverse the decline in smoking—giving new life to an old habit—or can they help people quit smoking? Here is what you need to know before picking up an e-cigarette.
What Are E-Cigarettes?
E-cigarettes are battery-operated devices shaped like cigarettes that provide a way to get nicotine. Nicotine is an addictive drug (it stimulates and relaxes) that is naturally found in tobacco. The most popular way for people to take in nicotine is to inhale it by smoking cigarettes. E-cigarettes also allow nicotine to be inhaled, but they work by heating a liquid cartridge containing nicotine, flavors, and other chemicals into a vapor. Because e-cigarettes heat a liquid instead of tobacco, what is released is considered smokeless.
Are E-Cigarettes Safer Than Traditional Cigarettes?
The key difference between traditional cigarettes and e-cigarettes is that e-cigarettes don’t contain tobacco. But, it isn’t just the tobacco in cigarettes that causes cancer. Traditional cigarettes contain a laundry list of chemicals that are proven harmful, and e-cigarettes have some of these same chemicals.
Since 2009, FDA has pointed out that e-cigarettes contain “detectable levels of known carcinogens and toxic chemicals to which users could be exposed.” For example, in e-cigarette cartridges marketed as “tobacco-free,” the FDA detected a toxic compound found in antifreeze, tobacco-specific compounds that have been shown to cause cancer in humans, and other toxic tobacco-specific impurities. Another study looked at 42 of these liquid cartridges and determined that they contained formaldehyde, a chemical known to cause cancer in humans. Formaldehyde was found in several of the cartridges at levels much higher than the maximum EPA recommends for humans.
The body’s reaction to many of the chemicals in traditional cigarette smoke causes long-lasting inflammation, which in turn leads to chronic diseases like bronchitis, emphysema, and heart disease.[5f] Since e-cigarettes also contain many of the same toxic chemicals, there is no reason to believe that they will significantly reduce the risks for these diseases.
There are no long-term studies to back up claims that the vapor from e-cigarettes is less harmful than conventional smoke. Cancer takes years to develop, and e-cigarettes were only very recently introduced to the United States. It is almost impossible to determine if a product increases a person’s risk of cancer or not until the product has been around for at least 15-20 years. Despite positive reviews from e-cigarette users who enjoy being able to smoke them where regular cigarettes are prohibited, very little is known about their safety and long-term health effects.
Can E-Cigarettes Be Used to Cut down or Quit Smoking Regular Cigarettes?
If a company makes a claim that its product can be used to treat a disease or addiction, like nicotine addiction, it must provide studies to the FDA showing that its product is safe and effective for that use. On the basis of those studies, the FDA approves or doesn’t approve the product. So far, there are no large, high-quality studies looking at whether e-cigarettes can be used to cut down or quit smoking long-term. Most of the studies have been either very short term (6 months or less) or the participants were not randomly assigned to different methods to quit smoking, including e-cigarettes. Many of the studies are based on self-reported use of e-cigarettes. For example, a study done in four countries found that e-cigarette users were no more likely to quit than regular smokers even though 85% of them said they were using them to quit. Another year-long study, this one in the U.S., had similar findings. People may believe they are smoking e-cigarettes to help them quit, but 6-12 months after being first interviewed, nearly all of them are still smoking regular cigarettes.
Until there are results from well-conducted studies, the FDA has not approved e-cigarettes for use in quitting smoking.
Teenagers, Children, and E-Cigarettes
The percentage of teenagers who have tried e-cigarettes has almost quadrupled in just four years, from 5% in 2011 to 19% in 2015. Three million U.S. students in middle school and high school tried e-cigarettes in 2015, according to the National Youth Tobacco Survey. And, 1 in 5 middle schoolers who said they had tried e-cigarettes also said they had never smoked conventional cigarettes.
E-cigarette use by young people is worrisome for a number of reasons:
1) The younger people are when they begin smoking, the more likely it is they will develop the habit: nearly 9 out of 10 smokers started before they were 18.
2) Nicotine and other chemicals found in e-cigarettes might harm brain development in younger people.
3) E-cigarettes may introduce many more young people to smoking who might otherwise never have tried it, and once they are addicted to nicotine, some may decide to get their “fix” from regular cigarettes. Whether e-cigarettes end up being a “gateway” to regular cigarettes or not, young people who use them risk becoming addicted to nicotine and exposing their lungs to harmful chemicals.
The sharp rise in young e-cigarette users highlights the need to stop manufacturers from targeting teenagers with candy-like flavors and advertising campaigns.
Even children who are too young to smoke have been harmed by e-cigarettes. The liquid used in e-cigarettes is highly concentrated, so absorbing it through the skin or swallowing it is far more likely to require an emergency room visit than eating or swallowing regular cigarettes. In 2012, less than 50 kids under the age of six were reported to poison control hotlines per month because of e-cigarettes. In 2015, that number had skyrocketed to about 200 children a month, almost half of which were under the age of two!
How Are E-Cigarettes Regulated?
The FDA was given the power to regulate the manufacturing, labeling, distribution and marketing of all tobacco products in 2009 when President Obama signed into law the Family Smoking Prevention and Tobacco Control Act and in 2010 a court ruled that the FDA could regulate e-cigarettes as tobacco products.
It wasn’t until 2016 that the FDA finally announced a rule to regulate e-cigarettes. Under the final rule, the FDA plans to ban the sale of e-cigarettes to anyone under the age of 18. The rule also requires all makers of e-cigarettes sold after February 15, 2007 to go through a “premarket review.” This is the process that the FDA uses to determine whether potentially risky products are safe. However, companies are allowed to have anywhere from 18 months to two years to prepare their applications. And it will take another year for the FDA to actually approve these applications. So don’t expect e-cigarettes currently on the market to be officially allowed to be sold by the FDA for another couple of years.
In the meantime, individual states have always had the power to pass laws restricting the sale and use of e-cigarettes. For example, in May 2013, the California state senate proposed a law making all e-cigarettes subject to the same regulations and restrictions as traditional cigarettes and tobacco products. However, that did not become law.
The Bottom Line
E-cigarettes have not been around long enough to determine if they are harmful to users in the long run. Unfortunately, many people, including teenagers, are under the impression that e-cigarettes are safe or that they are effective in helping people quit smoking regular cigarettes. Neither of these assumptions has yet been proven. Studies by the FDA show that e-cigarettes contain some of the same toxic chemicals as regular cigarettes, even though they don’t have tobacco. The big three tobacco companies—Lorillard, Reynolds American, and Altria Group—all have their own e-cigarette brands, so it’s not surprising that e-cigarettes are being marketed and advertised much the way regular cigarettes used to be. Here are the 7 Ways E-Cigarette Companies Are Copying Big Tobacco’s Playbook.
Unless you want to be a guinea pig, hold off on e-cigarettes until more safety information is available. And if you need help quitting or reducing the number of cigarettes you are smoking, check out the smokefree.gov website.
All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.
- Richard J. O’Connor Non-cigarette tobacco products: What have we learned and where are we headed? Tob Control. Author manuscript; available in PMC 2013 July 19. Published in final edited form as: Tob Control. 2012 March; 21(2): 181–190. doi: 10.1136/tobaccocontrol-2011-050281.
- “Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA.” FDA News & Events. FDA, 22 July 2009. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm.
- “Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA.” FDA News & Events. FDA, 22 July 2009. Web. 09 Aug. 2013. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm.
- Varlet et al. (2015) Toxicity of refill liquids for electronic cigarettes. International Journal for Environmental Research and Public Health. 12:4796-4815.
- Stoller, JK & Juvelekian, G; Chronic Obstructive Pulmonary Disease; 2010 Cleveland Clinic Center for Continuing Education. https://my.clevelandclinic.org/departments/respiratory/depts/chronic-obstructive-pulmonary-disease.
- Adkison SE, O’Connor RJ, Bansal-Travers M, et al. Electronic nicotine delivery systems: international tobacco control four-country survey. Am J Prev Med. 2013;44(3):207-215.
- Grana RA, Popova L, Ling PM. A Longitudinal Analysis of Electronic Cigarette Use and Smoking Cessation. JAMA Internal Medicine, published online March 24, 2014
- “Electronic Cigarettes” FDA News & Events. FDA, 25 July 2013. http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm
- Singh T, Arrazola RA, Corey CG, et al. Tobacco Use Among Middle and High School Students – United States, 2011-2015. CDC Morbidity and Mortality Weekly Report. April 15, 2016. 65(14);361-367.
- Centers for Disease Control and Prevention. Fact sheets: Youth and tobacco use. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/.
- US Department of Health and Human Services. Preventing tobacco use among youth and young adults. Atlanta, GA: US Department of Health and Human Services, CDC; 2012. http://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm.
- Kamboj A, Spiller HA, Casavant MJ, et al. Pediatric Exposure to E-Cigarettes, Nicotine, and Tobacco Products in the United States. Pediatrics. May 2016. In Press.
- “Regulation of E-Cigarettes and Other Tobacco Products.” FDA News & Events. FDA, April 25, 2011. http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm.
- Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. 21 CFR Parts 1100, 1140, and 1143 (2016).
Elizabeth Santoro, RN, MPH and Dr. Diana Zuckerman
There has been a lot of attention given to mammography screening in recent years. Some of this information has been confusing to women—at what age should I first have a mammogram, how frequently should I have repeat mammograms, and are mammograms even effective? These are questions that women both with and without breast implants have been trying to understand. Despite this confusion, the U.S. Preventive Services Task Force recommends screening every two years for women ages 50-74 who have an average risk of breast cancer. Women at high risk because of family history, BRCA gene mutations, or other reasons should discuss a screening schedule with their doctor. But, what does this mean for women who have breast implants? Are women with breast implants faced with different risks when undergoing a mammography screening? Will women with implants require special considerations during the procedure?
Delayed Breast Cancer Detection
Breast implants can interfere with the detection of breast cancer, because the implants can obscure the mammography image of a tumor. Implants therefore have the potential to delay the diagnosis of breast cancer. Although mammography can be performed in ways that minimize the interference of the implants, as described below, Miglioretti and her colleagues found that even so, 55% of breast tumors were missed, compared to 33% of tumors for women without implants.1 They also found that among newly diagnosed breast cancer patients who did not have any symptoms, the augmented women had larger tumors than those who did not have implants.
What is the impact of this possible delay in diagnosis? Research findings have been inconsistent, but a 2013 Canadian systematic review of 12 studies found that women with breast cancer who had breast implants are diagnosed with later-stage cancers than women with breast cancer who did not have implants.2
A delay in diagnosis could result in the woman needing more radical surgery or the delay could be fatal. A 2013 Canadian meta-analysis of five studies found that if women who had breast augmentation later developed breast cancer, they were more likely to die from it than women diagnosed with breast cancer who did not have breast augmentation.3
These studies indicate that for an individual woman, a delay in diagnosis could potentially result in death, and more research is needed to determine how often that happens, and under what circumstances. From a public health perspective, delays in diagnosis could potentially necessitate more radical surgery: a cancer that could have been treated at an earlier stage with breast-sparing treatments, such as lumpectomy, may instead require a mastectomy.3,4
What are the other possible problems that implants can cause regarding mammography?
A study by FDA scientist Dr. S. Lori Brown and colleagues describes problems that were reported to the FDA related to breast implants and mammography screening.5 The authors found 66 adverse events that were reported as either occurring during the mammogram or involving breast implants interfering with the mammogram. Forty-one reports of either silicone or saline breast implants- – almost two out of three reports– pertained to ruptures that were suspected as happening during mammography. The other 25 reports included delayed breast cancer detection, inability to perform the mammogram due to capsular contracture or because of fear that the implant would rupture, and pain/soreness during and after the procedure.
Description of the FDA Study
This study examined data from the Manufacturer and User Facility Device Experience (MAUDE) database. This FDA database collects mandatory or voluntary reports of medical device adverse events from physicians, breast implant manufactures, consumers, and others. The reports were received between June 1992 and October 2002 for events that occurred between June 1972 and June 2002. The mean age of the implant was 14.5 years, and ranged from 2-29 years.
The use of the MAUDE database has limitations. The FDA does not verify the information that is provided. Therefore, the FDA cannot guarantee that the information is accurate and complete. In addition, in some cases, a doctor and a patient could potentially report the same problem. On the other hand, most problems are not reported even once, since patient and physician reporting is voluntary. It is well-documented that the vast majority of problems arising from medical products are not reported to the FDA. As a result of these shortcomings, these data cannot be used to calculate the number of new adverse events expected for a given number of people in a defined time period.
Key Implications of the Studies on Implants and Mammograms
Potential Implant Rupture
The FDA warns that all implants will eventually break, and research shows that most women who have implants for ten years or longer will have at least one broken implant.6 The risk of breast implant rupture is known to increase as the implant ages. A study by Holmich and colleagues suggested that during the first ten years a woman has implants, most implants do not break, between 11-20 years most will break, and by the time they are more than 20 years almost all have broken.7 Women with implants have been told that mammography is safe for them, but the results of the Brown study suggest that the risk of rupture can be exacerbated by mammography.
Brown and her colleagues also reviewed the published research on implant rupture during mammography and found an additional 17 cases reported in medical journals. According to the American Society of Plastic Surgery, approximately half of the women who get breast implants are in their 20′s or early 30′s,8 which means that the implants are already broken or vulnerable by the time these women are old enough for screening mammograms.
Mammography may therefore increase the risk of a rupture earlier in the typical lifespan of implants, and the squeezing involved in mammography probably increases the risk of leakage in implants that are already ruptured. The potential risk of rupture or leakage needs to be weighed against the benefits of mammography by each individual woman. For women who are concerned about breast cancer, knowledge of mammography problems might discourage women from getting breast implants, or encourage them to have their implants removed and not replaced. Current guidelines encourage women with breast implants to have regular mammograms provided that the technician knows the woman has implants prior to the procedure and that special techniques are utilized.6 In light of this new research, those guidelines need to be reconsidered, especially for women with silicone gel breast implants, where leakage can cause permanent disfigurement and has unknown health risks.
Avoidance of Mammography
The Brown study also found that implants sometimes make it impossible to perform a mammogram. This can happen for two reasons. First, conditions such as capsular contracture, where the scar tissue around the implant tightens and causes the breast to become hard and misshapen, can make it very difficult or even impossible to perform the mammogram.9, 10 The compression of the breast that is required in order to perform the mammogram can be extremely painful if there is capsular contracture, and in some cases the hardness of the breast makes it impossible to compress the breast for the mammogram. Some women avoid getting mammograms because they are afraid of rupture and the latest research indicates that this is a reasonable concern.
Biomaterials testing of breast implants indicates that implants should only break under the most traumatic circumstances, and yet implants break for no apparent reason, as well as under pressure from mammograms.11 It is difficult to know how much risk a mammogram increases the risk of rupture since so little is understood about why implants break and under what circumstances.
What Does this Mean for Women?
Women considering breast implants and women with breast implants need to be informed consumers, and that includes knowing about the problems that arise from having mammograms with breast implants. This is true for all women, but especially breast cancer patients who may use implants on a healthy breast so that it will match the reconstructed breast after a mastectomy. (Detection of cancer in the reconstructed breast is unlikely to be a problem because mammography is not used after a mastectomy. Since breast cancer survivors are at greater risk for breast cancer in the breast that was not removed, compared to women who have not had breast cancer, survivors should have regular mammograms of the surviving breast, and need to know the risks.
Women with breast implants and those considering breast implants need to know that they will have a different mammography experience than women without implants, to try to improve the accuracy. The special techniques used will push the implant back to try to move it out of the way, and extra views will be taken. Even so, as reported earlier in this article, mammograms performed on women with implants will still miss more tumors than is typical of mammograms for women who do not have implants.7, 12 In addition, women with implants should expect that mammography will require more views and take longer, thus costing more and exposing them to increased levels of radiation. Unfortunately, the most common problem, capsular contracture, can make mammography more painful, less accurate, or even impossible to perform. In such cases other, more expensive tests, such as an MRI or ultrasound, may be required.
Women also need to understand that even if breast implants do not cause contracture or other problems, they will still interfere with mammography and mammograms might still cause rupture and leakage.
The bottom line is that women considering breast implants and those who already have them need to be informed about potential problems with mammography so that they can make the decisions that will help them reduce the risk of breast cancer and avoid the problems that arise with implant breakage and leakage.
For more information on breast implants, see www.breastimplantinfo.org.
What you need to know: Breast cancer, suicide, mastectomy, and breast implants
Summary of: Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide
2016 Update: When should women start regular mammograms? 40? 50? And how often is “regular”?
Prianka Waghray and Laura Gottschalk, PhD
Ovarian cancer is the fifth leading cause of cancer death in women in the U.S. 13 Most women who are diagnosed with cancer of the ovaries are at least 55 years old. When women are treated before the cancer has spread, 9 out of 10 will be alive five years later. Unfortunately, ovarian cancer is usually not detected until it has spread, and then only about 1 in 4 women will still be alive five years later.14
Is there a way doctors could find it earlier and save more lives? Screening is the key for several other cancers, but is less effective for ovarian cancer.
Is there a screening test for ovarian cancer?
There are ways of screening for ovarian cancer, but they are not very accurate. The current methods are: the CA-125 blood test, ultrasound, and pelvic examinations.15
Since 2012, the U.S. Preventive Services Task Force has recommended against annual ovarian cancer screening tests for women who do not have symptoms.3 They concluded that women who have no signs or symptoms, no family history of breast or ovarian cancer, and no increased risk based on their genes do not benefit from screening and may even be harmed by it.
The Task Force reviewed all the studies conducted on women with no symptoms of ovarian cancer to see if using two screening methods—the CA 125 blood test and transvaginal ultrasound—would help detect ovarian cancer earlier and save lives. They concluded that annual screenings using these two methods for women who have no symptoms did not reduce the number of women dying from ovarian cancer. Moreover, screening resulted in many women being told they might have cancer when they didn’t (false-positive test results), which led to anxiety and potentially harmful unnecessary surgeries.
A more recent study of over 200,000 British women also did not find that screening resulted in a significant decrease in ovarian cancer deaths compared to women who did not have any screening 16. These results further support the recommendation against screening in women with no symptoms.
The Task Force’s recommendation against screening does not apply to women who have a family history of breast or ovarian cancer or known genetic defects such as BRCA1 and BRCA2 gene mutations.
What are the signs and symptoms of ovarian cancer?
Women over 40 years of age who have any signs and symptoms associated with ovarian cancer should ask their doctor about getting screened. Since these symptoms are common to many other diseases as well, they should be reported to the doctor if they persist for two weeks or longer.1 According to the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI), you should pay attention to the following signs and symptoms:What you need to know about: Ovarian cancer. 17
- Unusual vaginal bleeding, such as irregular periods, bleeding that is heavier than normal for you, or that occurs when you are past menopause
- Discharge from your vagina that is not normal for you
- Pain or pressure in the pelvic or abdominal area (the area below your stomach and between your hip bones)
- A swollen abdomen
- Bloating or feeling full quickly while eating
- Feeling very tired all the time
- Back pain
- Change in bathroom habits, such as having to pass urine very often and with greater than usual urgency, constipation, or diarrhea
Screening Tests for Women with Symptoms or who are at Increased Risk:
CA-125 blood test:
The CA-125 blood test is a screening method that looks for a protein called CA-125, which is higher in women with ovarian cancer and some other conditions, such as non-gynecological cancers, and endometriosis.18 Since CA-125 can be associated with many different health conditions, it is not useful for determining ovarian cancer. For more information about CA-125 blood test go to http://dev.stopcancerfund.org/prevention/ovarian-cancer-ca-125-blood-test-does-it-work/
This type of ultrasound (sound waves) makes a picture of the uterus, ovaries and cervix.19 It can be used to detect small masses.3 Unfortunately, by the time the tumor in the ovaries is big enough to be detected, the cancer has already progressed to the later stages.
A pelvic exam is a physical exam a doctor does to check for problems or abnormalities in a woman’s female reproductive organs. Sometimes the doctor will combine a pelvic exam, which involves touching and lightly pressing on the lower abdomen, with a rectovaginal exam, in which the doctor inserts one finger into the vagina and another into the rectum while placing the other hand on top of the pelvis. This allows the doctor to feel for abnormal growths or lesions. These exams help detect tumors and other abnormalities in later stages of the disease.
Who is at risk and what to do if you have a family history of breast or ovarian cancer
The risk for ovarian cancer increases with age. Most women with ovarian cancer are over 60 years old. 20 Other factors that the risk include:
Having family members such as a mother, sister, aunt, or grandmother on either your mother’s or father’s side with either breast or ovarian cancer.
- Having already had uterine, breast or colorectal cancer.
- Having never given birth or having had trouble getting pregnant
- Coming from an Eastern European Jewish background (Ashkenazi)
- Having endometriosis
- Have tested positive for a genetic mutation called BRCA1 or BRCA2
The National Cancer Institute also warns that women who have taken menopausal hormone therapy—estrogen only or estrogen with progesterone—are at increased risk of ovarian cancer. The risk is greatest for women who took it for 5 years or more.721
If you have one or more of these risk factors or you have any of the previously mentioned symptoms associated with ovarian cancer, you should talk with your doctor. But remember, just because you have one or more of the risk factors above, doesn’t mean you have or will get ovarian cancer!
If several women in your family had ovarian or breast cancer at a young age or told you that they have the BRCA mutation, genetic counseling can help you find out if you have a higher risk as well. BRCA1 and BRCA2 increase a woman’s risk of breast and ovarian cancer (For more information, click http://www.center4research.org/2011/09/the-failed-promise-of-gene-based-tests-for-diagnosing-and-treating-cancer/). Genetic testing is not recommended for all women, just those with a family history of cancer.
What should I do if I have the BRCA1 or BRCA2 genetic mutation?
If you have the BRCA mutation, it doesn’t mean you will definitely get ovarian cancer. According to the National Cancer Institute, anywhere from 15% to 40% of women with BRCA1 or BRCA2 will develop ovarian cancer.22 However, you should talk to your doctor about the following strategies to prevent ovarian cancer or detect it early:
1) Surveillance: Patients should be screened regularly using currently available methods such as transvaginal ultrasound, CA-125 blood tests, and clinical exams to detect the presence of ovarian cancer.
2) Prophylactic surgery: This is surgery to prevent cancer by removing most of the “at-risk” tissues. One option is the removal of healthy fallopian tubes and ovaries. Although this type of surgery will reduce your chances of developing ovarian cancer, some women have developed ovarian cancer even after the prophylactic surgery.
3) Non-surgical ways to reduce your risk: Avoid hormone therapy (for more information, see http://dev.stopcancerfund.org/newsite/p-breast-cancer/menopause-and-the-ongoing-hormone-therapy-debate/); maintain a healthy weight; increase your physical activity; and reduce your alcohol intake to no more than 3 drinks a week. While hormone therapy increases the risk, birth control pills —which also contain hormones—tend to reduce your chances of getting ovarian cancer, even if you have BRCA1 or BRCA2. 9
What about Medicines?
Medicines such as tamoxifen and raloxifene are taken by some women, including BRCA carriers, to lower their chances of getting breast cancer, but have not been show to protect against ovarian cancer.9
The Bottom Line:
The U.S Preventative Services Tasks Force recommends against annual screening methods for ovarian cancer in women who have no symptoms and are not known to be at increased risk for ovarian cancer. Ovarian screening methods should only be used for women who have a family history of ovarian cancer, the BRCA1 or BRCA 2 gene mutation, or who have signs and symptoms of ovarian cancer.
Ovarian Cancer: What are the treatment options?
Comments of Members of the Patient, Consumer, and Public Health Coalition on “Testicular Toxicity: Evaluation During Drug Development – Guidance for Industry” [Docket No. FDA-2015-D-2306-0001]
We appreciate the opportunity to provide feedback to the FDA on the evaluation of testicular toxicity during drug development. The recommendations in the draft guidance are very important and we support the FDA’s effort to better characterize drug-induced testicular toxicity.
The Cancer Prevention and Treatment Fund is a charity that helps children and adults learn how to reduce their risk of cancer, and assists them in choosing the safest and most effective treatments. The Fund is a program of the National Center for Health Research. We are dedicated to enhancing the ability of the Food and Drug Administration (FDA) to promote and protect the health of adults and children through enforcement of the Food, Drug and Cosmetics Act.
As recognized by the FDA, the effects of many medications on male infertility are either unknown or inconclusive. Testicular toxicity (TT) is a sporadic and challenging issue in pharmaceutical drug development. Although the incidence of TT in pharmaceutical development is typically lower than the incidence of hepatic and renal toxicity, TT presents a challenging issue due to the lack of accurate and precise screening methods. The standards proposed in the Draft Guidance will advance the FDA’s ability to protect the public from drugs with the potential to cause testicular toxicity.
In an effort to strengthen the proposed safeguards, we suggest the following changes to the Draft Guidance:
Section III: Nonclinical Evaluation
The Draft Guidance recommends repeat-dose toxicology studies with at least 4 weeks of drug exposure in two species. We suggest a study duration of at least 3 months based on evidence reported in the literature. For example, a recent survey found that, while TT was generally identified in studies of short duration (less than or equal to 4 weeks), two sponsors indicated that TT had been identified only in studies of greater than or equal to 3 months duration: one detected TT in a 3-month rat study and the other saw TT in a 6-month rat study and in a dog study of more than 6 months in duration.
We also recommend that sponsors be required to submit all data from all species tested for testicular toxicity, and that discordant results from different species be transparent. Furthermore, if rodent studies are concerning but studies in large animal species do not raise the same level of concern, the sponsor should be expected to provide additional studies to help clarify the toxicity profile if the discrepancy cannot be explained. Sasaki et al. noted that it is frequently the case that testicular findings attributable to toxicity are recognized in only one of the two species used for preclinical toxicity testing. And, importantly, experience has shown it is usually not possible to dismiss findings in rodents based solely on the absence of similar observations in the large animal species. Despite this fact, about half of the sponsors in the study would dismiss worrisome rodent findings, if the toxicity was not corroborated in the second species tested.
While the Draft Guidance recommends demonstration of the reversibility of an adverse finding after cessation of dosing, we recommend the sponsor be required to explain the rationale for the timing and length of the recovery period. The justification should include consideration of the drug’s half-life and time required to achieve off-drug pharmacokinetic and pharmacodynamic steady state. Data provided in the survey by Sasaki et al. note the importance of a suitable duration of recovery. One sponsor reported worsening of testicular changes during the 28-day recovery period following a 28-day rat study. Another sponsor noted that, for one project, TT was only conclusively identified in a 3-month dog study after similar findings in the 1-month dog study had been dismissed as background lesions. The findings in the 3-month dog study suggested that mature germinal cells were affected, which may be why the lesion appeared to significantly worsen after 1 month. Because a drug may have lingering effects on upregulation or downregulation of receptors and other biochemical processes, the recovery period parameters (timing, length, etc.) must be transparently explained in the context of the drug’s biochemical effects.
Section IV. Monitoring of the Testes During Clinical Trials
The Draft Guidance recommends semen analyses be completed at baseline and at 13 weeks (one spermatogenic cycle) after initiation of the investigational drug. If adverse effects are seen during the first 13-week period, another 13-week evaluation, at one spermatogenic cycle (13 weeks) after final exposure to the investigational drug, is recommended to assess for recovery of changes in semen parameters. We recommend specifying that the first 13-week analysis must occur after the drug reaches steady-state concentrations, or at least 3 half-lives after initiation of the investigational drug. Likewise, if an analysis is completed after the final exposure, the Guidance should specify that it occur at least 3 half-lives after the end of dosing. This recommendation would be particularly critical for drugs with long half-lives, where the drug would not have reached its steady-state concentration at the end of only 13 weeks. For example, amiodarone, with a half-life of 58 days, would not be expected to reach steady state concentrations until about 25 weeks after its initiation.
In fact, the Final Guidance should require all preclinical and clinical analyses to occur on a timeline that can be justified based on the particular investigational drug’s unique pharmacokinetic and pharmacodynamic parameters.
Section V. Design of a Clinical Trial to Evaluate the Effect of a Drug on the Testes
The primary endpoint suggested in the Draft Guidance is a 50% decline in sperm concentration from baseline. A 50% decrease is a very large decrease and, at this time, no standard percent decline that predicts testicular toxicity has been identified. A smaller change may be relevant on a clinical and population level. We recommend substantially reducing the minimum decrease required as a primary endpoint or providing solid documentation to justify the use of such a large change in sperm concentration as a primary endpoint.
If you have any questions, please contact Tracy Rupp, PharmD, MPH, RD at firstname.lastname@example.org or 202-223-4000.
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By Carolyn Johnson, The Washington Post
July 10, 2015
A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-77 vote Friday morning.
The bill, called 21st Century Cures, was cheered by rare across-the-aisle support from politicians, with 230 co-sponsors nearly evenly split between Democrats and Republicans. The pharmaceutical industry, patient advocacy groups, and medical organizations also support the bill, which calls for an additional $8.75 billion for the National Institutes of Health.
The bill tries to address the impatience that stems from a major societal problem: despite billions of dollars of research into diseases that range from common cancers to the rarest genetic diseases, we still lack treatments for thousands of conditions. Many of its provisions seek to make the drug approval process less burdensome.
But its laundry list of provisions that tweak the process for approving new drugs or devices have raised significant concern from industry watchdogs and physicians who say the legislation is aimed more at helping drug and device companies than patients. Critics say the bill’s regulatory alterations do not address the real problem with the development of new therapies and could lead to the approval of treatments that don’t work and could even harm vulnerable sick people.
“The bill unfortunately offers a horse trade,” said Vijay Das, a healthcare policy advocate at Public Citizen, a patient advocacy organization. “It increases funding for the world-renowned NIH in exchange for providing perks for the pharmaceutical and medical device industries.” […]
“We share Congress’ desire to increase funding for NIH, but there are dangerous parts of this bill that many members of Congress did not fully understand,” Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank, said in a statement. “As often happens, well-funded pharma lobbying was more effective than experts’ concerns about patient safety.”
Read the full story here.