All posts by CPTFeditor

Have colon cancer? Skip the hot dogs, deli, and burgers

Colon Cancer, Colon Cancer, Diet, Habits, & Other Behaviors, Uncategorized
Caitlin Kennedy, Ph.D.

New research shows that eating red meat and processed meat increases the risk of colon cancer or of dying from colon cancer. The 2013 Cancer Prevention study by the American Cancer Society has been studying the impact of diet on cancer by following 184,000 patients for 18 years.1

Among the men and women diagnosed with colon cancer, those who ate more than 4 servings per week of red or processed meat before and after they were diagnosed with colon cancer were significantly more likely to die from colon cancer than those who ate fewer than 4 servings per week. Processed meats include deli foods such as hot dogs, sausage, bacon, and bologna, ham and other lunch meats, and bacon. Those who ate more than 4 servings per week had a 79% higher risk of dying from colon cancer compared to those who ate these foods less often. Those who had a family history of colon cancer and ate these foods frequently were especially likely to die from colon cancer.

Remember that “portion” sizes are smaller than what many people typically eat in a meal. For example, 2 hot dogs are considered 2 portions, and one double quarter pound hamburger is considered 3 portions. A large steak could be counted as 3 portions or even more.

Previous research has found connections between eating red meat frequently and an increased likelihood of being diagnosed with colon cancer and other health problems. However, this study is the first to show an increased risk of death from colon cancer.

Bottom line

These very popular foods are more harmful than any of us would like to think. The best way to prevent a variety of health problems, including colon cancer, is to limit red and processed meats in your diet. While the chicken or turkey you make in your oven is fine, the processed chicken and turkey sold at the deli counter or packaged in the supermarket are processed foods. Unfortunately, grilled foods including grilled chicken have also been associated with colon cancer.2 Fish and beans are other healthier sources of protein. If you have a family history of colon cancer, you should be especially careful to eat red and processed meats less frequently. Keep in mind that the American Cancer Society study found an increased chance of dying from colon cancer for men and women who ate these foods either before or after they were diagnosed with colon cancer.

The good news is that it’s never too late to start eating healthy and cutting back on your red and processed meat consumption! Even if someone is already diagnosed with colon cancer, eating less red meat and less processed meat can increase the chances of cancer survival.

Do lemons prevent cancer?

Diet, Habits, & Other Behaviors,
By Caroline Novas
2013

A widely circulating e-mail claiming to be from the Institute of Health Sciences (or the Health Sciences Institute) in Baltimore states that lemons are a “proven remedy against cancers of all types” and that lemons are 10,000 times stronger than chemotherapy.  The e-mail also says that pharmaceutical companies have kept the truth from us because lemons are much less expensive than the less effective synthetic versions that companies can sell for a large profit.

Although there is an “Institute of Health Sciences” in Baltimore that is “dedicated to uncovering and researching most urgent advances in modern underground medicine,” the Institute’s web site has no article about the cancer-fighting properties of lemons. It does, however, contain numerous articles promoting unproven alternative medicines and treatments. Most certainly, is not a credible scientific or medical source.

Regardless of the source, the claims the e-mail makes are NOT correct. Lemons are not a “proven remedy against cancers of all types,” and no studies have ever been done that would compare the effectiveness of a lemon to chemotherapy.

A few studies indicate that lemons and other citrus fruits have naturally occurring substances that may have cancer fighting properties, namely modified citrus pectin and limonoids.  These properties have not been tested in humans.

Modified citrus pectin (MCP)

Modified citrus pectin is a carbohydrate found in the peels of citrus fruits modified to be absorbed into the intestinal tract for easier human consumption. In its natural state, pectin is an indigestible dietary fiber.  Animal studies have found that MCP can inhibit the spread of prostate, breast, and skin cancer to other organs. MCP makes it difficult for cancer cells to break off and spread, although it has no impact on the initial tumor.

However, there is almost no information about whether MCP is effective in humans.  One study that measured prostate cancer in humans treated with MCP after standard treatment failed, showed a slowing in the progression of the disease, as measured by doubling time for prostate specific antigen (PSA). The longer the doubling time for PSA in patients with prostate cancer, the better their prognosis is expected to be. Patients taking MCP for 12 months showed a statistically significant increase in prostate specific antigen doubling time (PSADT), when compared to the 12 month period before they began taking MCP.  Unfortunately, the study used no control group (men that did not take MCP after standard treatment failed) and therefore could not compare the survival rates of men who took MCP after standard treatment failed, with those who did not.

Limonoids

Limonoids are chemicals found in citrus peels that are responsible for lemons’ bitter taste. Research has found that at very high levels, limonoids are capable of slowing cancer cell growth and inducing apoptosis (cell death). However, studies have focused on animals and in vitro human breast cancer cultures (breast cancer cells removed from the human body and studied in a laboratory). As a result, there is little information about limonoids’ effectiveness in preventing or combating cancer in humans.

The bottom line

Although lemons have health benefits, the claims that “lemons are a proven remedy against cancer of all types” and “lemons are 10,000 times stronger than chemotherapy” are certainly false.  Furthermore, while a few studies have looked into the anti-carcinogenic properties of modified citrus pectin and limonoids and found some promising results, not enough research has been done to prove its effects on humans. It’s possible that in the future, after more research, a medicine will be developed to prevent or fight cancer using these ingredients; if so, it will probably be in much higher concentrations than found in nature

MCP and limonoids are not unique to lemons; they are found in all citrus fruits, which have many known health benefits and should be part of any healthy diet.

References:

The Health Sciences Institute. http://hsionline.com/

Glinksy Vladislav and Avraham Raz. (2009). Modified citrus pectin anti-metastatic properties: one bullet, multiple targets. Carbohydrates Research. 28;344(14):1788-91

BW Guess et. al (2003). Modified citrus pectin (MCP) increases the prostate-specific antigen doubling time in men with prostate cancer: phase ll pilot study. Prostate Cancer and Prostatic Diseases. 6, 301-304

Polouse SM, Harries ED, and Patil BS. (2005) Citrus limonoids induce apoptosis in human neuroblastoma cells and have radical scavenging activity.  Journal of Nutrition. 135(4): 870-7

The Op-Ed: FDA panels: too many conflicts or too little expertise?

Press Releases
By Diana Zuckerman, PhD
June 12, 2013

This Op-Ed was published by Pharmalive.com, to see the original post, click here.

Last week, a paper in the journal Science argued that a 2012 law that loosened conflict-of-interest restrictions on FDA advisory panels could not only allow more drugs with troubling side effects to enter the marketplace, but was actually unnecessary. The discussion, which analyzed the utility of caps placed on waivers, once again raised the thorny debate over conflicts and panel members (read more here). But Diana Zuckerman who is president of the National Research Center for Women & Families, a think tank, and long-time FDA observer, argues this only tells part of the story…

Should FDA Advisory Committee members be allowed to have financial conflicts of interest regarding the medical product they are recommending for approval (or recommending against approval)?  The answer is not as simple as it might seem.

The Searle Civil Justice Institute of George Mason University held a Congressional briefing this week on the subject and I was invited to participate. The funding for the institute came from the late Daniel Searle, former ceo of the pharmaceutical company GD Searle. The focus  was a report entitled “FDA Advisory Committees: An Empirical Examination of Conflicts of Interest,” that is being written by Joe Golec, Professor of Finance at the University of Connecticut, and two of his colleagues at the George Mason University School of Law.

The statistics compiled for the report focus on voting patterns for all the FDA advisory committee meetings on new prescription drugs in recent years. The results indicate that the committee members who get waivers allowing them to serve on the committee despite conflicts of interest vote very similarly to the committee members who don’t get waivers. The authors conclude that this shows that conflicts of interest don’t unduly influence voting patterns on FDA advisory committees. They also conclude that the members with conflict of interest waivers tend to have more expertise, and therefore are an important addition to the committees.

I do not doubt the data that the authors presented, but I question their conclusions. The publicly available information about conflicts of interest on FDA advisory committees is too limited, and the analysis misses the flavor of advisory committee meetings, as well as the not-so-subtle nuances regarding conflicts of interest.

FDA defines conflicts of interest as financial ties during the last 12 months, so even extensive financial ties in the recent past – or even 12 months plus one day earlier — would not be included and would not require a waiver. The FDA advisory committee that met over a year ago to discuss whether Yaz oral contraceptives are too risky to stay on the market is a perfect example.  Advisory committee members with previous extensive financial ties to Bayer, which sells the pills, but who did not have waivers voted in support of Yaz (and Yasmin, Beyaz, and other contraceptives made with the hormone drosperinone). This shifted the vote to keep these pills on the market.

In addition to the many conflicted advisory committee members who don’t get waivers because their financial ties are more than a year old, voting patterns don’t tell the whole story.

I’ve been to dozen of advisory committee meetings, and I’ve seen how members with financial ties to the company or product often talk more at the meetings. They may talk more because they know more. They may talk more because they want to show the company how smart or helpful they are. Whatever the reason, their greater participation can be influential. Many advisory committee members ask no questions and make no comments at these meetings, until required to explain their votes. The advisory committee members with more direct knowledge of the products, including those with financial ties to the company or the product can greatly influence the vote when they talk more, ask softball questions or steer the conversation toward topics of benefit to the company. These members may have grants or consulting relationships with the company.

For committee meetings reconsidering safety issues for popular products such as Vioxx, Avandia, Yaz, osteoporosis drugs, surgical mesh, hip joints, and breast implants, advisory members who have frequently prescribed or implanted the products being reviewed are not considered biased and also do not have waivers. These potentially more knowledgeable but less objective members influence how others vote, making a comparison between members with waivers and members without waivers rather meaningless.

After attending so many advisory committee meetings, and studying 89 of these meetings in ourreport what is striking to me is how many of the members are not truly experts worthy of giving advice to the FDA. In fact, many of these voting members don’t understand statistics and ignore the clinical trial data unless they support their desire to get the drug on the market or keep it on the market.

Advisory committee members tend to be clinicians who want more drugs to be approved, making comments like “if this drug can help one patient, we should get it on the market.” For example, I recently went to an advisory committee meeting for Merck’s new sleeping pill, suvorexant, where the members ignored the FDA’s concerns that the data indicated many patients would have trouble driving to work the next day and could even fall asleep at the wheel (read here).

These sleeping pills had a half-life of 12 hours. Most of the advisory committee members didn’t care about that at all. Instead, they focused on the fact that people have insomnia and need help falling asleep. I think that people who take sleeping pills are mostly concerned about getting enough sleep so that they can function well the next day. A good night’s sleep doesn’t seem so beneficial if it means falling asleep while driving to work the next day.

At a meeting a few months ago, FDA advisory committee members recommended approval for a TB drug that was five times as likely to kill the patients as the current standard of care, a statistically significant difference. The sponsor, Janssen, speculated that the high death rate happened by chance in this randomized double blind clinical trial.  Amazingly, that ridiculous justification was good enough to convince most of the advisory committee members. Apparently, they didn’t understand that the entire purpose of a statistical analysis of a randomized double blind clinical trial is to determine whether or not a difference in outcome occurred by chance – and this one almost definitely didn’t.

I am very pleased that FDA Commissioner Margaret Hamburg has asked agency officials to reduce the number of advisory committee members with waivers. Unfortunately, the waivers are just the tip of the conflict of interest iceberg. FDA advisory committee members continue to have many members with financial ties to the companies and no disclosure of who they are. The media have publicly outed some of those advisory committee members, but most of the time that information is not known to the public, or the reporters covering advisory committee meetings.

Meantime, the bigger problem is that so many FDA advisory committee members don’t understand statistics or truly value or understand the results of clinical trials. FDA is supposed to make decisions based on scientific evidence that patients are more likely to be helped than harmed by a new medication or medical device. FDA approval should not be based on speculation or wishful thinking about whether a drug might “help at least one patient.” When committee members ignore the documented risks and focus on their hope for unproven benefits, thousands of patients die unnecessarily.

The number of FDA advisory committee members with conflict of interest waivers is lower than ever, but many members still show clear bias in favor of approving drugs and medical devices that are not proven safe or not proven effective. Whether those FDA advisors have financial conflicts of interest, other types of bias, or lack of interest in scientific evidence will not matter to the patients who are harmed by these medical products. Unfortunately, that will be the legacy of too many FDA advisory committee meetings.

Maryland Playground Closes due to Possible Toxicity

News Stories & Editorials
Mila Mimica and Tracee Wilkins, NBC4 News Washington: June 13, 2013

A brand new playground in Greenbelt, Md. closed this week over concerns about a potentially toxic material in the mulch used for ground covering.

Just a few weeks after the playground opened, the City of Greenbelt closed it down because the mulch used was made of old tires.

“It’s actually a product that not too long ago President Obama put in the White House playground,” Greenbelt Assistant City Manager David Moran said. “The science we saw particularly from the EPA showed that it was below levels of concern.”

However, Diana Zuckerman with the Cancer Prevention and Treatment Fund said parents had good reason to be concerned about that mulch.

“Rubber mulch contains phthalates, which are chemicals that affect hormones, and other chemicals that are known to be harmful to our health,” Zuckerman said.

Monday night, Greenbelt County Council agreed to try an alternative called “Poured-In-Place” rubber.

The park remains closed in the near future until the mulch is replaced.

 

To view the original article, click here.

Senate Panel Approves Tighter Oversight of Compounding Pharmacies, but Bill is Under Fire

News Stories & Editorials
Lena Sun, Washington Post: May 23, 2013

Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.

The bill, approved Wednesday by the Senate Health, Education, Labor and Pensions Committee, would create a new category of regulation by the Food and Drug Administration for these companies. The bill now heads to the full Senate.

The House has not drafted a bill, but a House subcommittee will hold a hearing Thursday about state and federal laws governing the specialized pharmacies.

The Senate bill would establish a new category of FDA oversight that would apply to a part of the industry that has grown rapidly over the past two decades, from small corner pharmacies into businesses that operate like large-scale drug manufacturers. Many of these pharmacies, known as compounders, make a wide array of sterile medications, including antibiotics and painkillers, and ship them across state lines. Unlike traditional compounding pharmacies that custom-mix medication for individual patients based on prescriptions, these compounders often ship drugs without a prescription.

These products, unlike drugs made by major pharmaceutical manufacturers, are not ­FDA-approved. And the enterprises do not face the same level of scrutiny from the FDA that traditional drugmakers do.

Under the Senate bill, companies that make sterile products without or in advance of a prescription and sell those products across state lines would be required to register with the FDA and be subject to regular inspections.

Some consumer groups say the category is too narrowly defined. Only companies that meet all the criteria would be covered. Excluded would be large compounding pharmacies that sell defective or life-threatening oral drugs,topical creams and gels, said Nasima Hossain with the U.S. Public Interest Research Group, a consumer advocacy organization.

A compounder that sells in only one state would also be exempt. In addition, “anything in pill form wouldn’t qualify, and many chemotherapy drugs are in pill form,” said Diana Zuckerman, president of the Cancer Treatment and Prevention Fund.

Public Citizen, a consumer advocacy group, has opposed the creation of a separate category of FDA oversight for large-scale compounding pharmacies. It says it would be better to require the companies to follow the safety requirements that apply to commercial drug manufacturers.

The FDA has sought greater oversight of certain types of compounding pharmacies since the fall outbreak. But in a statement, the FDA said it was concerned that certain aspects of the Senate bill would limit the agency’s enforcement ability.

“Unfortunately, the proposed bill does not yet provide the clarity necessary to appropriately oversee this industry and may limit FDA’s ability to effectively protect the public health,” the statement said.

One small wording change in the bill that passed the Senate panel could weaken the FDA’s authority, industry experts said. It says traditional compounding pharmacies are to be defined “pursuant to state law.”

State laws vary, so a company that might be considered a drug manufacturer in one state could be defined as a traditional compounding pharmacy in another and be regulated differently depending on state law.

Allan Coukell, an expert on drugs at the Pew Charitable Trusts, said Pew supports the Senate approach even though it has limitations. “We do think big compounders ought to be under FDA oversight,” he said.

In the fall outbreak, the New England Compounding Center of Framingham, Mass., shipped more than 17,000 vials of steroid shots to doctors’ offices and clinics in 23 states. Some of the vials were contaminated; the outbreak killed 55 people and sickened 686. In the eight months since the NECC-linked meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions, according to a report by the Senate committee.

Allison Preiss, a spokeswoman for Sen. Tom Harkin (D-Iowa), chair of the panel, said the bill is a work in progress and will continue to be refined as it moves through the legislative process.

To view the original version in the Washington Post, click here.

Flaxseed: What is it and Can it Keep you Healthy?

Breast Cancer, Diet, Habits, & Other Behaviors, Other Cancers, Ovarian Cancer
Carla Bozzolo, Cancer Prevention and Treatment Fund

1024px-Brown_Flax_SeedsSuddenly, everyone is talking about adding flaxseed to your diet.  What is flaxseed and how can eating it make you healthier?

What is Flaxseed?

Flaxseed is the seed of the flax plant and can be eaten as whole seeds, ground into a powder (flaxseed meal), or the oil can be taken in liquid or pill form.[1] There is evidence that it is a great way to incorporate dietary fiber, antioxidants, and omega-3 fatty acids into your diet.

Flaxseed has been shown to lower cholesterol in some people and it may even reduce the risk of breast cancer. People take flaxseed to help with many digestive conditions, including chronic constipation, diarrhea, diverticulitis (inflammation of the lining of the large intestine), irritable bowel syndrome (IBS), ulcerative colitis (sores in the lining of the large intestine), gastritis (inflammation of the lining of the stomach), and enteritis (inflammation of the small intestine). According to the National Institutes of Health (NIH), more study is needed to prove that flaxseed benefits people who have these conditions.[2]

What’s in This Miracle Seed?

Omega-3 essential fatty acids

Flaxseed is the richest source of omega-3 fatty acids,3 which is good for our hearts, brains, and normal growth and development.4 Omega-3 fatty acid can also be found in fish, plants, nuts, and oils made from nuts. No matter how you consume flaxseed—whole, ground or the oil—you will increase your intake of omega-3 fatty acids.

Lignans

Lignans are a type of plant estrogen that may help slow down certain cancers—cancers that depend on hormones to grow. Lignans also work as an antioxidant, which means they protect cells from the damage that comes with aging. Antioxidants—found in berries and many other foods—may help fight certain cancers. Lignans are concentrated in the coat of the seed so when flaxseed is expressed into oil, the anti-cancer and antioxidant benefits of the lignans are lost.

Dietary fiber

Dietary fiber helps regulate the digestive system and can lower bad cholesterol. Dietary fiber in flaxseed is only found in whole and ground flaxseeds, not in flax oil.

Flaxseed and Breast Cancer

For women who have gone through menopause, a small daily serving of flaxseed (just over half a teaspoon) was enough to lower breast cancer risk. While more research is needed, some studies suggest that for younger women who have not yet gone through menopause flaxseed reduces the risk of breast cancer and slows down the progress of certain breast cancers and other cancers that need estrogen to grow. A study published in 2013 found that eating flaxseed decreased a woman’s chance of getting breast cancer by 82%.

Flaxseed and Cholesterol

Flaxseed (but not flax oil) seems to decrease bad cholesterol among people who have relatively high cholesterol. Once again, women who already went through menopause seemed to benefit most: their “bad” cholesterol dropped more than the bad cholesterol of men or younger women. This is important for older women, because bad cholesterol tends to increase after menopause, as estrogen levels decline.

Who Benefits the Most?

Flaxseed has the potential to benefit everyone as a great source of dietary fiber with almost no side effects.  People with high levels of bad cholesterol and women who are post-menopausal benefit the most.

Different Ways to Eat It

Flaxseed is sold as whole seeds, ground seeds (flaxseed meal), liquid oil, and oil in a pill form. It can easily be added to cereal, baked goods, salad, yogurt, and many other types of food.  Since whole seeds tend to go through the body undigested, ground seeds are considered to be more beneficial.  Flaxseed oil delivers essential fatty acids but it doesn’t have fiber or lignans. If you want to get all the benefits of flaxseed—omega-3 fatty acids, fiber, anti-oxidant and cancer-fighting properties—choose ground flaxseed.  

Cautions

Few side effects have been reported from flaxseed. When taken to reduce constipation, it should be taken with plenty of water.

The fiber in the flaxseed may also lower the body’s ability to absorb medications that are taken by mouth, so it should not be taken at the same time of day that you take pills or dietary supplements.

The Bottom Line

Flaxseeds are a great source of dietary fiber and omega-3 essential fatty acids for men and women of all ages. They don’t have any known serious side effects, and ground flaxseeds are easy to include in the foods you eat every day.

References:

  1. National Institutes of Health. National Center for Complimentary Medicine. Herbs At A Glance: Flaxseed and Flaxseed Oil. April 2012: http://nccam.nih.gov/health/flaxseed/ataglance.htm
  2. National Institutes of Health. National Library of Medicine. Flaxseed: MedlinePlus Supplements. August 2011. http://www.nlm.nih.gov/medlineplus/druginfo/natural/991.html
  3. National Institutes of Health. National Cancer Institute. Antioxidants and Cancer Prevention: Fact Sheet. July 2004. href=”http://www.cancer.gov/cancertopics/factsheet/prevention/antioxidants”>http://www.cancer.gov/cancertopics/factsheet/prevention/antioxidants  ▲
  4. Brown L, Rosner B, Willett W, and Sacks F. Cholesterol-lowering effects of dietary fiber: a meta-analysis. American Journal of Clinical Nutrition. 1999; 69:30-42.  ▲
  5. Cotterchio M, Boucher BA, Kreiger N, Mills CA, & Thompson LU. Dietary phytoestrogen intake–lignans and isoflavones–and breast cancer risk (Canada). Cancer Causes Control.2008; 19:259–272  ▲
  6. Buck K, Zaineddin AK, Vrieling A, Linseisen J, & Chang-Claude J. Meta-analyses of lignans and enterolignans in relation to breast cancer risk. American Journal of Clinical Nutrition. 2010; 92:141–15  ▲
  7. Velentzis LS, Cantwell MM, Cardwell C, Keshtgar MR, Leathem AJ, & Woodside JV.Lignans and breast cancer risk in pre and post-menopausal women: meta-analyses of observational studies. British Journal of Cancer. 2009; 100:1492–1498  ▲
  8. Lowcock E, Cotterchio M, & Boucher B. Consumption of flaxseed, a rich source of lignans, is associated with reduced breast cancer risk. Cancer Causes Control. 2013. E-publicaton ahead of print. Retrieved from href=”http://www.ncbi.nlm.nih.gov/pubmed/23354422″>http://www.ncbi.nlm.nih.gov/pubmed/23354422.  ▲
  9. Pan A, Yu D, Demark-Wahnefried W, Franco O, and Lin X. Meta-analysis of the effects of flaxseed interventions on blood lipids. American Journal of Clinical Nutrition. 2009; 90:288-297.  ▲
  10. Fukami K, Koike K, Hirota K, Yoshikawa H, and Miyake A. Perimenopausal changes in serum lipids and lipoproteins: a 7-year longitudinal study. Maturitas. 1995; 22:193-197.  ▲

 

Angelina Jolie’s Decision

Breast Cancer, Breast Cancer, In the News, News Stories & Editorials
Diana Zuckerman, PhD, Huffington Post: May 16, 2013

When I read about Angelina Jolie’s announcement this week, I cringed.

I have greatly admired her willingness to speak out on important issues over the years. Her public announcement about her mastectomies will certainly reassure some women that losing a breast to breast cancer isn’t quite as frightening as it had once seemed. But Ms. Jolie is a powerful role model to millions of women. What are the unintended consequences of the role she is modeling regarding breast cancer?

Is breast cancer so frightening that it is better for a woman to remove her breasts before she is even diagnosed? Obviously, that isn’t what Ms. Jolie is saying. She has one of the breast cancer genes (BRCA1), and that greatly increases her chances of getting breast cancer.

However, the extremely high risk that she quoted from her doctor (87 percent chance of getting breast cancer) was based on old, small studies. Newer studies have found that the risk of getting breast cancer for an average woman with BRCA1 is 65 percent. Since being overweight and smoking increase the risk and exercising and breastfeeding lower the risk, Ms. Jolie’s risk of breast cancer, even with the BRCA1 gene, could be considerably lower.

Of course, the lifetime risk of breast cancer would still be high, but it wouldn’t be nearly as high a risk during the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 14 percent chance of getting breast cancer before she turns 50. That’s not nearly as frightening, and with regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives. And, it is possible that by the time Ms. Jolie (or any other woman with BRCA1) got breast cancer in the future–if she ever did–the treatments available would be even more effective than they are today.

Thanks to mammograms, women are getting diagnosed with breast cancer at much earlier stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). And yet, American women are undergoing mastectomies at a higher rate than women in other countries–many of them medically unnecessary. Breast cancer experts believe that many women undergoing mastectomies don’t need them and are getting them out of fear, not because of the real risks.

As an actress whose appeal has focused on her beauty, surgically removing both her breasts when she didn’t have cancer was a very gutsy thing to do. But if we care about women’s health, we need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

Nobody can second-guess Angelina Jolie’s choice–it’s hers alone to make. Fortunately for her, she has access to the best reconstructive surgeons in the country, and they will keep her breasts looking as natural and beautiful as possible, an advantage that most implant patients don’t have. If she has any of the common problems with her breast implants, she can afford to get those problems surgically fixed whenever she wants to. She can also afford breast MRIs every other year ($2,000 each), which the Food and Drug Administration recommends as a way to make sure that the silicone from the implants is not leaking into the lymph nodes.

Angelina Jolie is not in any way an average woman, and what felt right for Angelina Jolie might not be right for most women who are afraid of getting breast cancer, and not even for most women with the BRCA1 or BRCA2 gene.

I thank Ms. Jolie for speaking up about her decision, and I thank the many cancer experts who are doing their best this week to explain why double mastectomies are not the best choice for most women. Let’s use this teachable moment to have a frank discussion of the treatment choices for breast cancer and to encourage women to make decisions based on their own situations, not on the choice of a celebrity, however admirable she is. For each woman, it’s important to weigh her own risk of cancer–in the next few years, and not just over her lifetime–and the risks of various treatments, and to make the decision that is best for her.

To see original article, click here

Testimony of Dr. Jennifer Yttri at FDA Advisory Committee on Tivozanib

Other Cancers, Other Cancers, Policy, Testimony & Briefings
May 2013

I am Dr. Jennifer Yttri and I am speaking on behalf of the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families. Our non-profit research center scrutinizes medical data, evaluating scientific evidence of benefits and risks for patients.  We analyze and review research and provide objective and understandable health information to patients, health care providers, and policy makers.  Our organization does not accept funding from pharmaceutical companies and therefore I have no conflict of interest.

Today’s fundamental question is whether the one completed Phase 3 clinical trial is enough to approve the new drug tivozanib as a treatment for patients with renal cell carcinoma.

FDA guidelines recommend two trials that support efficacy of a drug. In some cases, FDA will approve a new drug based on only one trial if that trial shows a significant improvement over existing therapy. In the FDA’s own words: “A conclusion based on two persuasive studies will always be more secure than a conclusion based on a single, comparably persuasive study. Reliance on only a single study will generally be limited to situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity… and [when] confirmation of the result in a second trial would be practically or ethically impossible.”

The NDA submitted for tivozanib relies on one phase 3 study comparing tivozanib to sorafenib. While tivozanib was shown to increase progression free survival by 3 months in patients with renal cell carcinoma, it did not improve overall survival. In fact, there was a non-significant lower overall survival for tivozanib, suggesting the drug may actually harm patients more than it helps them. This one study alone is not enough to meet the FDA’s guidelines for drug approval.

In addition, the study results have inconsistencies that raise red flags about the research and about the drug itself.

1.       Patients receiving tivozanib had increased progression free survival, so why were they more likely to die in the first 30 days due to disease progression, compared to sorafenib. This does not make sense. The deaths in the first 30 days could be due to chance, but the disease free survival could also be due to chance.  More research is needed to clarify the risks as well as the long-term benefits.

2.       FDA noted that 70% of sorafenib patients stopped taking the drug at least temporarily and 44% ended up with a reduced dose. This is much higher than other studies – for example one study highlighted by the FDA had only 14% interruption and 10% reduction.  There is no logical explanation for this, but these unusual problems could make sorafenib seem inferior to tivozanib, when in fact it might be superior.

These inconsistencies may be due to chance or to irregularities in how the studies were conducted in other countries.  Standard of care and assessment of disease varies in the US and other countries, and fewer than 10% of patients enrolled in the trial were in the US.  We agree with the FDA reviewer that it is preferable to enroll US patients, so that the study reflects the disease burden and treatment in the US and can provide better insight into treatment outcomes for US patients.

Regardless of the reason for the inconsistencies in the study, a second, independent, phase 3 study would help determine the safety and efficacy of this drug for treatment of renal cancer.

We urge you to recommend that the FDA require the sponsor to complete a second trial to confirm the positive effect of tivozanib on PFS; address the concern over lower OS; and provide better information on how generalizable the results are in the US population. Based on the data provided, there are no ethical concerns with requiring another trial. With the additional information, the FDA can make an informed decision as to whether tivozanib meets their standards of safety and efficacy.  That is not possible based on this one study with such inconsistent results.

Comments of the Patient, Consumer, and Public Health Coalition on HELP Committee’s Draft Proposal on Pharmaceutical Compounding

Legislation, Policy
May 2013

Chairman Tom Harkin
731 Hart Senate Office Building
Washington, DC 20510

Dear Chairman Harkin:

As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide our views on the HELP Committee’s draft proposal on pharmaceutical compounding.

We are very concerned that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises.  Although it might reduce the likelihood of the deaths from products made by companies such as NECC, it will do little to protect the health and safety of thousands of patients who are unwitting customers of large compounding pharmacies that sell defective oral drugs to treat cancer or other life-threatening diseases, or that sell large quantities of sterile products within a state.

An example of the types of patients that would not be protected by the draft legislation are the cancer patients who received diluted cancer drugs from a Kansas City compounding pharmacy in 2000.  We are also concerned about compounders that will avoid FDA oversight by limiting their high-volume sales of sterile products to a single state. The risk posed by sterile compounded products, or any other high-risk medical products, does not change based on whether or not the product crosses a state line.

We are concerned that the draft proposal too narrowly defines compounding manufacturers and does not give the FDA adequate authority to regulate compounding manufacturers.

In addition, the draft proposal does not give the FDA access to records of companies that define themselves as traditional compounders, making it next to impossible for the FDA to identify compounding manufacturers that have misrepresented themselves as traditional compounders. This is particularly worrisome because the FDA now attempts to obtain the records and inspect any pharmacy which has been the subject of complaints.  Pharmacies have challenged the FDA in court, but the agency has been able to prevail in some cases.  This legislation could potentially reduce the agency’s current authority.

We strongly urge you to ensure that the final legislation clarifies and enhances the FDA’s authority to regulate compounding pharmacies that have the potential to harm thousands of patients, even if they do not meet all three criteria for non-traditional compounding manufacturers set forth in the current draft version of the bill.

Below are our comments on specific sections of the draft proposal:

Compounding Manufacturer (page 2)

We agree that compounding manufacturers should be regulated by the FDA. However, the definition of compounding manufacturer is too narrow. It requires that entities meet all three of the following criteria: 1. Compounds at least one sterile drug. 2. Compounds before receiving a prescription. 3. Ships (sells) those drugs interstate.

In order to protect the public, the definition of compounding manufacturers should be broader, such as any entity that meets either the 2nd or 3rd criteria.  Sterile drugs are not the only high-risk drugs made by compounders.  Incorrect dosage for non-sterile cancer or other life-safe-giving drugs can be just as deadly, and are almost impossible to detect since drugs for seriously ill patients are not always effective.  Therefore, when a cancer patient or heart patient dies after taking a compounded medication, it is unlikely that anyone will question the medication, and would instead assume that the drug just didn’t work on that patient.

In addition, a compounded antimicrobial drug that is not as potent as it should be will be ineffective and also add to our growing antibiotics resistance problem. By making the definition of manufacturing compounders too narrow, we are setting the stage for future public health disasters.

To protect patients across the country, we strongly believe that compounders who sell across state lines or sell “in anticipation” of prescriptions should be regulated as compounding manufacturers.  This protection is especially essential when compounders sell drugs with the potential to save lives, where defective drugs could result in death or serious injury.

Traditional Compounder (page 3)

The phrase “compounds a drug in limited quantities” needs to be defined.  What does “limited quantities” mean?  A dozen, one hundred, or more?

Drugs That May Not Be Compounded (page 6)

The Secretary needs more flexibility to amend the list as needed.  The bill should specify that the Secretary has administrative authority to update the Do Not Compound List (drugs added or taken off the list) and should not have to seek regulatory authority from Congress whenever a change is needed.

Licensed Pharmacist Oversight (page 18)

What does the term “direct supervision over the operations of the compounding manufacturer” mean?  If a compounding manufacturer produces products 24 hours a day, does that mean a licensed pharmacist will be there at all times, directly supervising?  Or could a licensed pharmacist just set up the operations and rarely be present? We urge you to clarify this definition to ensure robust oversight.

Listing of Drugs (page 18)

We support the six-month look-back on drugs that are made by compounding manufacturers. This allows the FDA to scrutinize them for products that should not be compounded such as commercially available products.

Adverse Event Reporting and Maintenance of Records (page 19)

We support Adverse Event Reporting and Maintenance of Records for compounding manufacturers. However, to truly protect public health, traditional compounders should also be required to report adverse events in a timely manner and maintain records of all serious adverse drug events for 10 years.

Labeling of Drugs (page 20)

The goal of the labeling is to make sure health care professionals and patients know that the drug is a compounded product.  We support the label stating: “This is a compounded drug.” However, the draft proposal adds “or a reasonable comparable alternative statement that identifies the drugs as a compounded drug.” That sentence opens the door for vaguely worded compounded drug labels, which may be misunderstood by patients and healthcare providers.  The alternative statement should either be deleted from the final draft or changed to “a statement that uses language suitable for an 8th grade reading level that clearly identifies the drug as a compounded drug that has not been evaluated by the FDA for safety and effectiveness or compliance with manufacturing and sterility standards.”  In addition, we support the proposed labeling “not for resale” on compounded drugs sold to health care entities (page 17).

Amount of Establishment Fee (page 22)

The establishment fee for compounding manufacturers is designed to cover inspection costs. How was the $15,000 fee ($5,000 for small firms) per drug establishment determined?  Did the FDA suggest this amount?  What is the average cost for the FDA to inspect manufacturing compounders?   Will the FDA have sufficient resources to do their job?

Applications of Inspection Requirements to Compounding Manufacturers (page 32)

The FDA should have access to the records of compounding manufacturers and traditional compounders.  If the FDA cannot review traditional compounders’ records, then it does not have the means to independently verify that the companies are actually traditional compounders.  This lack of access creates a Catch-22.  Unless the FDA can prove the pharmacy meets its compounding definition, it cannot exert oversight.  But it cannot prove the definition without access to records.

This lack of access also will make it difficult for the FDA to respond to complaints it receives about pharmacies, particularly in states where oversight may be lax.

What if the company meets all criteria of a compounding manufacturer but has not registered with the FDA?  At the very least, the FDA should have, upon the receipt of a complaint or evidence that the pharmacy is violating federal law, access to all records and the right to inspect.

Language Missing in the Proposed Draft 

There is no mention of penalties for compounding manufacturers who fail to follow the new regulations. FDA should have the authority to issue substantial civil penalties to serve as a disincentive for any compounding manufacturers that fail to register and pay an establishment fee to the FDA, or that fail to report adverse events within 15 days, and fail to retain records for ten years.  Those penalties must be stringent enough to discourage compounders from considering penalties part of the cost of doing business.

Other suggested revisions to the draft

The draft should make clear that states that wish to ban the sale of certain compounded pharmaceutical products will not be pre-empted from doing so.

The draft should also require a GAO study of the impact of the bill on the FDA’s ability to effectively oversee compounding pharmacies, and address problems swiftly to prevent patient harm.

The draft should require the FDA to warn the public and the compounding pharmacy’s customers of any violations that threaten public health within 24 hours of discovering such violations.

Thank you for the opportunity to comment on this important draft legislation.  It is our goal to work with you to make the improvements necessary so that this bill will provide the protections from unsafe medical products that the American public expects and deserves.

 

American Medical Student Association

Annie Appleseed Project

Consumers Union

Community Catalyst

Jacobs Institute of Women’s Health

National Consumers League

National Research Center for Women & Families

National Women’s Health Network

Center for Science and Democracy, Union of Concerned Scientists

U.S. PIRG

WoodyMatters

 

 

For more information, contact Paul Brown at (202) 223-4000 or pb@center4research.org

Can Taking Fish Oil Supplements Help Lung Cancer Patients Undergoing Chemotherapy?

Diet, Habits, & Other Behaviors, Lung Cancer, Treatment & Management
Katherine Ip, Cancer Prevention and Treatment Fund

Fish oil is a well-known dietary supplement that is likely to reduce the risk of getting heart disease. More research is needed to find out if it may also reduce high blood pressure, menstrual pain, the risk of stroke, and the symptoms of arthritis, bipolar disorder and ADHD.[1]

Some studies have suggested that fish oil and the omega-3 fatty acids it contains might also help improve the effectiveness of chemotherapy for cancer patients, while reducing the bad side effects.  The types of chemotherapy tested include anthracyclines, cisplatin, irinotecan, and alkylating agents. Only two studies were done on humans, and the others were done on animals or cancer cells in test tubes.[2]

Fish Oil Supplements, Lung Cancer, and Chemotherapy

Late-stage non-small cell lung cancer (NSCLC) is usually treated with chemotherapy, but chemotherapy is often ineffective.[3] And, the current treatments have very unpleasant side effects that can severely harm the quality of a patient’s life, so researchers are always looking for ways to minimize damage to the body’s healthy cells while still attacking cancer cells with full force.[4]

In 2011, a very small study by researchers from Canadian Universities looked at whether fish oil could help chemotherapy patients with non-small cell lung cancer (NSCLC) that has spread to the lymph nodes or to other parts of the body (Stage III and Stage IV).[5] Patients with these late stages of lung cancer, on average, only live about 2 years after being diagnosed.

Since the cancer had already spread, all the patients were given the same palliative chemotherapy, aimed at reducing cancer symptoms and improving the patient’s quality of life, rather than curing the patient. Researchers only included lung cancer patients who had never had chemotherapy before. Only 15 of the patients were given fish oil and 31 were not. When they started their chemotherapy, the patients in the group taking fish oil had a choice of taking four capsules a day (each with 1 gram of fish oil), or 7.5 milliliters of actual fish oil, which provides the same amount of omega-3 fatty acids.

How did Fish Oil Affect Survival?

The patients who took fish oil responded much better to chemotherapy than those who didn’t. Their tumors shrank more in size or shrank more quickly, and they were almost twice as likely to be alive a year after treatment compared to the patients who didn’t take fish oil (60% compared to 39%). These results held true regardless of how old the patient was, whether the patient was a man or woman, and how much muscle mass the patient had.  The latter is important because patients with lower muscle mass tend to suffer from more negative side effects from chemotherapy.

Patients who did not take fish oil were more likely to have their cancer get worse after two cycles of chemotherapy than patients who took fish oil. And, more of the patients who took fish oil were able to complete all of their planned chemotherapy, because they experienced less side effects for the same levels of chemotherapy as patients who did not take fish oil. Since the patients who took fish oil felt well enough to receive more cycles of chemotherapy, their tumors also shrank more and they lived longer.

Did Fish Oil Affect Quality of Life?

When chemotherapy kills the body’s healthy cells (think of it like “friendly fire”), it can cause side effects such as nausea, vomiting, and constipation, and it also lowers the body’s ability to fight infection. Since the patients taking fish oil were able to complete more cycles of chemotherapy, we would expect them to have worse side effects. Instead, the side effects listed above were about the same for patients taking fish oil and those that did not. The researchers suspect that the reason why is that fish oil protected the healthy cells from the chemotherapy, but not the cancer cells. Their findings are consistent with a study where mice with lung cancer responded better to treatment when fed fish oil.[6] They are also consistent with a study in which breast cancer patients responded better to chemotherapy when their breast tissue had a higher concentration of DHA, one of two fatty acids found in fish oil.[7]

Is There a Catch?

The study of fish oil and lung cancer included only 31 patients not taking fish oil and 15 patients taking fish oil. Such a small study does not provide adequate evidence, but it does mean more research is warranted.

The Bottom Line:

In this one small study, taking fish oil supplements appears to help late stage lung cancer patients tolerate their chemotherapy better so that they can get the most benefit from it.  And, fish oil is inexpensive and has no known risks. More research is needed to find out if fish oil is usually effective for lung cancer patients and possibly other cancer patients. Since fish oil is very safe, if you or someone you know is about to start chemotherapy, it’s probably a good idea to start taking fish oil supplements right away.

References:

  1. Natural Medicines Comprehensive Database. Omega-3 Supplements: Medline Plus supplements. 2012. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/natural/993.html. Accessed February 4, 2013.
  2. Bougnoux P, Hajjaji N, Ferrasson MN, Giraudeau B, Couet C, Le FO. Improving outcome of chemotherapy of metastatic breast cancer by docosahexaenoic acid: a phase II trial. Br J Cancer. 2009; 101: 1978-1985.
  3. Pujol JL, Barlesi F, Daures JP. Should chemotherapy combinations for advanced non-small cell lung cancer be platinum-based? A meta-analysis of phase III randomized trials. Lung Cancer. 2006; 51: 335-345.
  4. Carney DN. Lung cancer–time to move on from chemotherapy. N Engl J Med. 2002; 346: 126-128.
  5. Murphy RA, Mourtzakis M, Chu QSC, Varacos VE, Reiman T, & Mazurak VC. Supplementation with fish oil increases first-line chemotherapy efficacy in patients with advanced nonsmall cell lung cancer.
  6. Yam D, Peled A, Shinitzky M. Suppression of tumor growth and metastasis by dietary fish oil combined with vitamins E and C and cisplatin. Cancer Chemother Pharmacol. 2001; 47: 34-40.
  7. Bougnoux P, Germain E, Chajes V, et al. Cytotoxic drug efficacy correlates with adipose tissue docosahexaenoic acid level in locally advanced breast carcinoma. Br J Cancer. 1999; 79: 1765-1769.