Category Archives: Reports & Medical Journal Articles

Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?

Diana Zuckerman, PhD, American Journal of Public Health: November 2017

The new US Food and Drug Administration (FDA) commissioner Scott Gottlieb has worked for pharmaceutical companies for most of his career, so it may have surprised some public health advocates when he responded to congressional pressure by taking on the hot issue of drug pricing as one of his first priorities.

In his blog written for the FDA Web site, Commissioner Gottlieb echoes the view of many public health advocates when he says: “Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. […]

I agree with Commissioner Gottlieb that these sound like useful strategies, because generic drugs have been estimated to have saved $1.2 trillion between 2003 and 2012. However, I question how much these strategies can accomplish. Is this a Band-Aid approach to a much more complex problem—and if so, is the FDA part of the problem?

Generic Drugs, Competition, and Drug Prices

The Government Accountability Office (GAO) reported in 2016 that the price of 50-milligram capsules of the antidepressant clomipramine HCL, which is used to treat obsessive-–compulsive disorder, increased by more than 2000% in one year: from 34 cents per capsule in 2013 to $8.43 per capsule in 2014.  The 20-milligram capsules of piroxicam, to treat arthritis, increased by more than 2000% from 2010 to 2015: from 9 cents to $1.82 per capsule. The price of digoxin, a commonly prescribed heart medication, increased by 2800% in a single year.  Despite these increases, the GAO found that from 2010 to 2015 the cost of generics decreased by 59%. Nevertheless, the GAO reported that the price of 315 generic drugs went up by 100% or more during those years, causing financial difficulty for many patients. […]

When a large number of generic manufacturers are making the same product, the average price usually falls to 20% of the branded price, or even lower. There are exceptions, however. For example, eight companies make ursodiol, a treatment for gallstones.  In 2013, the cost was 45 cents per capsule, but in May 2014, Lannett increased its price to $5.10 per capsule, and its competitors soon followed.

Is the FDA Part of the Problem?

The contribution of the FDA to high drug prices was noted recently when the FDA approved an old, commonly used drug for a type of Duchenne muscular dystrophy. Deflazacort had not previously been approved in the United States, but many patients imported generic versions from Europe or Canada for $1000 to $2000 for a year’s supply. When the FDA approved it, a US company gave it a new name, Emflaza, and a new price tag, $89 000 per year (more than a 6000% increase).

Another glaring example of the unpredictable impact of competition involved brand-name drugs for hepatitis C. When Gilead put Sovaldi on the market in late 2013, it cost $1000 per pill: $84 000 for a 12-week course of treatment. The public and policymakers were incensed at what was considered an outrageous cost, but experts assumed the price would soon drop because other similar drugs were in the pipeline. Instead, the official price increased, despite two competing drugs….

FDA Drug Approval

Clearly, when the FDA approves new drugs that create competition, it does not necessarily lower prices. Congress has passed laws to require the FDA to approve drugs and devices more quickly, which Commissioner Gottlieb also supports. This has resulted in lower standards over the last two decades5 and has contributed to the high cost of medical care.

Read the original article here.

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health

Jay G. Ronquillo and Diana M. Zuckerman, Milbank Quarterly: September 12, 2017

Policy Points:

  • Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial.
  • No studies of medical devices and software assess the impact on patient safety of the FDA’s current regulatory safeguards and new legislative changes to those standards.
  • Our analysis indicates that current regulations are necessary but not sufficient for ensuring patient safety
  • New laws will reduce safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.

Context: Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration’s (FDA’s) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy.

Methods: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details.

Findings: A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety.

Conclusions: Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.

Read at: https://www.milbank.org/quarterly/articles/software-related-recalls-health-information-technology-medical-devices-implications-fda-regulation-digital-health/

New study explains why so many cancer drugs don’t work

Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Most of us know cancer patients who received drugs that drained their energy and joy of living but didn’t seem to benefit them.  In some cases, the cancer stopped growing within a few months and even began to shrink, but ultimately the patient did not seem to live even a day longer.cancer patient

Why is that?

A key problem is that cancer drugs do not have to be proven to prolong anyone’s life in order for the Food and Drug Administration (FDA) to approve them.  Researchers at the National Cancer Institute and Oregon Health & Science University reviewed all the cancer drugs approved by the FDA from 2008 to 2012 (Kim & Prasad).  They found that 26 of the 54 cancer drugs were not required to be proven to prolong or save lives, but instead were approved based on what are called surrogate markers, which are “signs” such as tumor shrinkage that are expected (but not guaranteed) to predict patients’ longer life.

Once the drugs were approved, thousands of patients started taking these drugs and paying for them, despite the lack of evidence of a meaningful health benefit.  However, the FDA did require the companies to keep studying the drugs to find out if those medicines were actually extending lives.

The answer, unfortunately, is that many of these drugs did not help patients live longer or better.  Only five of the 36 drugs were proven to help patients live longer.  Eighteen drugs (50%) failed to extend life and 13 (36%) have unknown impact on survival because no data on them are available to the public.  Since companies are very good at sharing information when their drugs are proven effective, experts assume that means those 13 drugs are not proven to work.

In November, the National Center for Health Research published a new study, looking more carefully at those 18 ineffective drugs.  We found that only one was proven to improve quality of life – which isn’t surprising, since cancer drugs so often cause nausea, vomiting, hair loss, and exhaustion.  Two made quality of life worse, and the other 15 new cancer drugs either did not improve quality of life (6), or there is not enough evidence to know if they do or not.  We also looked at the cost of those cancer drugs and found something that doctors, patients, family members, and lawmakers need to know:  the new cancer drugs that are not proven to benefit patients in any way cost just as much as the ones that are effective – up to $170,000 per patient.  In fact, the most expensive of the 18 cancer drugs was a thyroid cancer drug (Cabozantinib, also called Cabometyx or Cometriq) that had no benefit to survival compared to placebo, and also caused patients to have a worse quality of life.

Meanwhile, the ineffective cancer drugs remain on the market and Medicare and insurers are still paying for them.  When the president of the National Center for Health Research asked FDA officials why they take so long to rescind the approval of ineffective cancer drugs, they stated that they still think those drugs might be effective, but that it is difficult to prove.  They pointed out that once a cancer drug is approved, it is very difficult to keep patients in a clinical trial long enough to know if the drug actually saves lives.  We agree it is difficult; if a patient is in a clinical trial and not doing well, he or she is likely to drop out, whether they are on the new drug, old drug, or placebo.  But that’s a major problem: if the FDA is approving cancer drugs on short-term, inconclusive data, and then requiring better studies that they know are unlikely to be completed appropriately, that’s quite a Catch-22.  It means that the FDA is approving cancer drugs knowing that we’ll never know if they are safe and effective or not.

This article is based on this study in JAMA Internal Medicine.1

Table 1. Most New Cancer Drugs That Don’t Help Patients Live Longer Also Don’t Improve Their Quality of Life

cancer-drug-table-page-001

 

a FDA review notes that sponsor stated one study found a difference in deterioration of QoL that was statistically significant in favor of bevacizumab.

b On November 18, 2011, FDA revoked accelerated approval of the breast cancer indication for bevacizumab.

c One subgroup analysis of Japanese patients found a QoL benefit.

d Includes any combination of the other categories (better, no statistical difference, worse).

Lack of African Americans in Breast Cancer Studies Results in Less Effective Treatment and Higher Death Rate

Laurén A Doamekpor PhD, MPH and Diana Zuckerman PhD, Cancer Prevention & Treatment Fund

The disparity in breast cancer mortality between Black and White women has widened in our country’s most populated states.[1] Cancer experts usually conclude that although there have been advances in breast cancer screening, prevention and treatment, these advances have not been equally available to Black and White patients.

Most experts fail to mention that there is a fundamental problem that could explain this disparity:  lack of research on the kinds of treatment that are most effective for Black women with breast cancer.  Dr. Laurén Doamekpor and Dr. Diana Zuckerman of the National Center for Health Research published a short article in Cancer Epidemiology that agreed that although access is a problem, a lack of racial and ethnic diversity in clinical trials exacerbates this disparity.[2]

Clinical trials have provided essential information on the treatments and prevention strategies that work best, but those studies have focused on White women.  Patients of color are very underrepresented in clinical trials that are submitted to the Food and Drug Administration (FDA) when a company applies for FDA approval.[3] Since relatively few people of color are included in studies submitted to the FDA, and even fewer studies analyze and report safety and efficacy separately by race or ethnicity, scientists have not discovered  treatments that are safe and effective for minority patients if those patients metabolize certain drugs differently or tend to have different types of cancer, such as the “triple negative breast cancer” that is more common among Black women than White women. This contributes to racial disparities when treatments are not adequately tested for  safety or efficacy in these populations.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. Hunt BR, Whitman S, Hurlbert MS. Increasing Black:White disparities in breast
    cancer mortality in the 50 largest cities in the United States. Cancer Epidemiol
    2014. http://dx.doi.org/10.1016/j.canep.2013.09.009.
  2. Doamekpor LA, Zuckerman DM. Lack of diversity in cancer drug clinical trials may exacerbate racial disparities in mortality rates. Cancer Epidemiol
    2014. http://dx.doi.org/10.1016/j.canep.2014.06.007
  3. Food and Drug Administration. FDA Report: Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products, August 2013; 2014, Available at: http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf (accessed 31.03.14)

Summary of: Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide

Diana Zuckerman, PhD, Women’s Health Issues: August, 2016

Breast augmentation is the most common cosmetic surgery in the United States, and many women are also encouraged to choose breast implants for reconstruction after a mastectomy.  However, studies in the United States and Scandinavian countries have shown that suicide rates are higher for women with implants.

These studies raise a key question: Do implants increase the risk of suicide or do pre-existing mental health problems increase the likelihood of undergoing breast implant surgery and also increase suicide risk?  And is the link between implants and suicide different for women undergoing reconstruction after a mastectomy than it is for women considering breast implants to augment the size of healthy breasts?

Several researchers and plastic surgeons have suggested that women undergoing breast augmentation tend to have lower self-esteem and that explains higher suicide rates.  This article is the first to take a comprehensive look at implants and suicide, by considering information from studies measuring self-esteem, self-concept, mental health, and quality of life among women before and after getting breast implants for either augmentation or reconstruction.

Which Comes First:  Breast Implants or Depression?

There are six studies that found that suicide rates are between two times and 12 times higher for augmentation patients than for similar women without breast implants, including other cosmetic surgery patients.  There is one study that found that mastectomy patients were 10 times as likely to kill themselves if they have breast implants.

Suicide rates are relatively high for breast cancer patients, but this study shows that it is much higher for mastectomy patients with implants than for mastectomy patients without implants.

Research also shows that women who decide to get breast implants tend to have higher self-esteem than average women before getting breast implants and do not show any other signs of poor mental health.  However, two years after getting breast implants, women tend to report feeling worse about themselves and to describe themselves as less healthy.  Those results are similar whether the women are augmentation patients or reconstruction patients.

In other words, the confident women who get breast implants tend to be less confident and have a less positive self-image afterwards – except in terms of how they feel about their breasts.  In addition, they are more likely to kill themselves.  That is true whether they got implants for augmentation or for reconstruction after a mastectomy.

In conclusion, scientific evidence suggests that breast implants may have risks to mental health. Although suicide among women with implants is below 1% in every study, the rates ranging from 0.24% to 0.68% are significantly higher statistically and clinically than rates for comparable women without implants.

Many plastic surgeons tell patients that breast augmentation will make them feel better about themselves, and that reconstruction after a mastectomy will make women feel “whole” again.  Instead, the research suggests that breast implants tend to have a negative impact on women, and that any women who feel depressed or have low self-esteem prior to getting breast implants should never be encouraged to get breast implants.

In order to understand the relationship between breast implants and suicide, studies are needed that provide appropriate mental health testing before surgery and  years afterwards, with interviews used to ask the women themselves about their experiences with implants and how they feel about themselves and their lives.

Download the article as a pdf here.
Read the article online here.

Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide

Diana M. Zuckerman PhD, Caitlin E. Kennedy, PhD and Mishka Terplan MD, MPH, Women’s Health Issues: April 2016

Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide

SUMMARY

Breast augmentation is the most common cosmetic surgery in the United States, with approximately 300,000 surgeries annually (American Society for Aesthetic Plastic Surgery, 2012). Many women seek breast augmentation to improve their lives, self-esteem, or relationships (Crerand, Infield, & Sarwer, 2007); however, numerous research reviews have concluded that suicide rates are higher for women with implants (Crerand et al., 2007; Lipworth & McLaughlin, 2010; McLaughlin, Lipworth, Murphy, & Walker, 2007; Rohrich, Adams, & Potter, 2007; Sansone & Sansone, 2007; Sarwer, Brown, & Evans, 2007).  In addition, there is evidence of an increased risk of suicide for women who undergo reconstruction with implants after mastectomy, compared to other mastectomy patients (Le et al, 2005).  Other published research on the impact of breast implants on mental health provides insight into the possible reasons for the apparent link between breast implants and suicide.

Article available at http://www.whijournal.com/inpress.

 

US Device Industry and FDA “Colluded” on Legislation to Weaken Regulatory Oversight

Jeanne Lenzer, THE BMJ: December 17, 2015

US Food and Drug Administration officials had multiple meetings with leaders of the medical device industry to craft legislation that critics say will severely weaken regulatory oversight of the industry, an investigation by the online news service Inside Health Policy has found.

The revelations, discovered in emails and documents obtained under the Freedom of Information Act, have led to renewed calls by professional and public interest watchdog groups to defeat companion legislation to the proposed 21st Century Cures Act, which has been referred to the Senate. They have also called to oppose the approval of Robert Califf as a nominee for the role of FDA commissioner because he took part in meetings with the Advanced Medical Technology Association (AdvaMed), a trade association for medical technology companies.

[…]

Michael Carome, director of the health research group at Public Citizen, a public interest organization, described as “unseemly and inappropriate” the meetings between the FDA and the device industry to craft the language in the act.

Carome said that Califf’s “participation in this collusion with industry” should, at a minimum, put Califf’s nomination as FDA commissioner on hold pending an investigation. Carome said, “The attitudes [Califf] has developed over his decades long history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety.”

The National Physicians Alliance, together with Public Citizen and six other organizations, wrote a letter to the House of Representatives on 19 May, stating that the 21st Century Cures Act “fails to ensure a . . . scientifically based approach” to drug and device approval and that it will allow “unsafe and ineffective drugs and medical devices to enter the market.”

[…]

The FDA defended its meetings with the industry, telling The BMJ that “FDA officials routinely meet with a diverse group of stakeholders.” The agency said that it had met with 12 representatives of public interest and professional organizations who attended a meeting on 28 October, after the bill was referred to the Senate in July.

Diana Zuckerman, president of the National Center for Health Research, whose organization requested the October meeting, told The BMJ that none of the more than two dozen non-profit organizations that are members of the Patient, Consumer, and Public Health Coalition had been invited by the FDA to help develop any provisions of the 21st Century Cures Act or its Senate companion bill.

She said, “There’s a world of difference between talking about approval standards in general and crafting specific legislative language. It is outrageous that FDA officials and regulated industry are sitting down to craft legislative language to give to congressional staff.”

[…]

BMJ 2015; 351 Cite this as: BMJ 2015;351:h6820

To read the full article, click here.

What would impact of 21st Century Cures Act be on cancer and your healthcare costs?

 NOVEMBER 23, 2015

This summary of an analysis published online in the prestigious medical journal BMJ on November 23, 2015, shows that using preliminary research to approve new medical treatments has high costs for patients’ lives and healthcare dollars.  These three very promising medications did not work, and one of them caused skin cancer and also made Alzheimer’s symptoms worse.

21ST CENTURY CURES ACT AND SIMILAR POLICY EFFORTS: AT WHAT COST?

BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h6122 (Published 23 November 2015) Cite as: BMJ 2015;351:h6122

By Diana M Zuckerman, Nicholas J Jury, and Christina E Silcox

A controversial proposed law in the United States, the 21st Century Cures Act, is described by supporters as an innovative attempt to jump start the process of finding new cures for the thousands of diseases that currently lack effective treatments. But would this bill promote new cures, or increase the availability of new medical products that do not necessarily work? Alzheimer’s disease is often cited as an example of a devastating disease with enormous costs and no cure in sight. We examine the potential harms and costs that would have been incurred by three Alzheimer’s drugs that were rejected under current Food and Drug Administration approval standards but could have been approved under the standards promoted by 21st Century Cures and similar legislation.

We selected for analysis all the Alzheimer’s drugs reviewed by the FDA within the past five years for which a determination was made, to determine the likely impact of the proposed changes on their approval.

All three drugs had impressive results in preliminary clinical trials.  Two of the drugs showed great improvement based on the well-established biomarker of beta amyloid plaques on the brain, and the third based on tests of memory and cognition.  When larger, better designed clinical trials were conducted, however, two of the Alzheimer’s drugs were found to be ineffective, and the third drug caused an increase in memory problems and an increase in skin cancer.

Cost estimates

More than five million patients in the US have Alzheimer’s disease, about 1.3 million of whom are being treated with an Alzheimer’s drug. To conservatively estimate market share, we looked at the cholesterol lowering drug atorvastatin (Lipitor), which garnered 18% of market share during its first year on the US market based on biomarker data. If one of these drugs had gained a similar market share it would translate to 234,000 patients a year taking a drug that put them at risk of a greater loss of cognitive skills than if they had taken a drug already on the market, or perhaps no treatment at all. If semagacestat was the drug approved, almost 19,000 more patients would have developed skin cancer, based on the phase III results.

Most current Alzheimer’s drugs are available as generics, which has reduced their price. Donepezil has most of the US market share. The brand name version (Aricept) costs about $7500 a year at Walgreens, the largest pharmacy chain in the US. The brand name versions of memantine, galantamine, rivastigmine, and memantine-donepezil each cost over $5000 a year at Walgreens.

New drugs are priced based on the current market price of competing drugs, not on research and development costs. A conservative estimate is that a promising new Alzheimer’s drug would be priced similarly to Aricept ($7,500 a year). This is 87% more than generic donepezil, almost doubling the cost for any patient who switched to the new drug.

Assuming 18% of the market share before postmarket studies  are completed, we estimate the cost of treating 234,000 patients at $1.76 billion a year, or $7 billion over four years until postmarket studies were completed.  Given the modest benefit of current Alzheimer’s drugs, and the impact of current direct-to-consumer advertising practices in the US, a promising new drug would be expected to garner higher prices and more prescriptions, so the cost could easily double.

Since the cognitive abilities of patients with Alzheimer’s disease tend to worsen over time regardless of treatment, it would be virtually impossible for physicians to realize that semagacestat was causing cognitive decline or that the other drugs were ineffective. Physicians would also have been unlikely to notice that semagacestat increased patients’ risk of skin cancer. It would not have been until post-market phase III studies of cognitive and health outcomes were completed years later that physicians and families would have realized that the drugs were ineffective and possibly harmful.

Under pressure from Congress and industry, FDA standards have loosened in recent years, and the agency often approves products based on biomarkers that have good but inconclusive evidence of clinical benefit. For example, cancer drugs are often approved based on tumor shrinkage or progression-free survival and studies conducted after the drugs are in widespread use have shown that many do not help patients live longer. Osteoporosis drugs have been approved based on bone mineral density or microscopic bone fractures, rather than hip fractures that harm health. The proposed law and several other Congressional proposals would weaken current FDA standards further. As our examples show, this could to lead to patients taking ineffective and potentially harmful drugs and waste billions of healthcare dollars.

Read the whole article here.

Startling link between pregnant mother’s exposure to DDT and daughter’s risk of breast cancer

by Ariana Eunjung Cha, Washington Post
June 17, 2015

Banned by the United States in 1972, the insecticide DDT is best known as the impetus for the modern environmental movement. Since Rachel Carson’s bestseller “Silent Spring” sounded the alarm about the poisonous effects of the chemical on wildlife, the environment and human health, numerous studies have linked it to birth defects, miscarriage and reduced fertility.

Its role in cancer has been less clear. The Environmental Protection Agency classifies DDT as a “probable” carcinogen. Roughly three dozen studies have been published about DDT and breast cancer risk for women who lived during its peak use in the 1950s, but a 2014 meta-analysis of that research found that there was no significant association between exposure and breast cancer risk.

They may have been looking at the wrong generation of women.

A new study published Tuesday in the Journal of Clinical Endocrinology and Metabolism found a startling link between pregnant women exposed to DDT and the breast cancer risk to their daughters.

The study tracked the daughters of women who were part of a study at the Kaiser Foundation Health Plan from 1959 to 1967 near the city of Oakland, Calif. During that time DDT was widely used and accumulated in the fat of animals that we eat and was found in milk, butter, cheese and other products in the food supply. It was also in a number of consumer products, including some wallpaper.

During that period the participants gave birth to 9,300 daughters. Every mother had some measurable level of DDT in her blood. Researchers determined the level of exposure to DDT in utero by analyzing stored blood samples that were taken from the mothers during pregnancy or shortly after they delivered their babies. By using state records and surveying the daughters, who are now in their late 40s and early 50s, they were able to figure out which ones developed breast cancer.

The researchers found that elevated levels of DDT in the mother’s blood were associated with almost a four-fold increase in her daughter’s risk of breast cancer and that this was independent of the mother’s history of breast cancer. They also determined that those with higher levels of exposure were diagnosed with more advanced breast cancer.

About 83 percent of those who got breast cancer had estrogen-receptor positive breast cancer and were more likely to develop HER2-positive breast cancer in which a genetic mutation produces an excess of a protein. In previous studies, DDT has been found to interfere with the function of estrogen and, separately, to activate the HER2 protein, which may explain the link.

Barbara A. Cohn, one of the study’s authors and the director of Child Health and Development Studies at the Public Health Institute in Berkeley, Calif., said the 54-year study is “the first to provide direct evidence that chemical exposures for pregnant women may have lifelong consequences for their daughters’ breast cancer risk.”

Elizabeth Ward, senior vice president of intramural research for the American Cancer Society, said the group of mothers and daughters the researchers are studying is a “unique resource” for studying potential associations between maternal blood levels of chemicals and risk to their children.

“What makes this study interesting is its analysis of in-utero exposure,” she said. However, she said that the number of breast cancer cases was small — 103 — so “the results should be interpreted cautiously.”

In an interview, Cohn said the paper is part of a series of studies on chemicals and their effects on hormones or  development during gestation. Earlier studies she led have looked at the effects of DDT on the time of pregnancy of the daughters of women exposed (they found it could slow their ability to become pregnant or shorten it depending on level of exposure) and on incidence of testicular cancer among the male children (those exposed to the highest levels had an almost three-fold risk  compared with those with lower exposure). She is also studying the effect of other chemicals used for stain control on carpeting and waterproofing for food containers.

“We are looking at a vulnerable period in utero,” she said. “In some ways it is not surprising that early in life is a time when some of these chemicals can have a strong effect.”

Earlier work by Cohn also supports the idea that timing of the exposure matters. In a 2007 paper, she found that DDT affected breast cancer only for women who were exposed before age 14.  The meta-analysis that didn’t find any association between DDT and exposure looked at studies of women who were exposed later in life.

DDT is still widely used in other parts of the world, including regions of Africa and Asia, where it is used to control the spread of malaria.

“Our findings don’t change the perception of benefits, but they do change the perception of risks,” Cohn said. “We are hoping that policymakers will use this information as they continue to debate the use of DDT around the world.”

 

See original article here.

Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants

Diana Zuckerman, PhD, Nyedra Booker, PharmD, MPH, and Sonia Nagda, MD, MPH

Published in Reproductive Health Matters, December 2012

Tens of thousands of defective silicone breast implants were recalled in Europe in 2011–12 soon after the FDA’s unrelated announcement that a rare cancer of the immune system was associated with all saline and silicone gel breast implants. These developments raised questions about whether U.S. and European regulations were protecting patients from unsafe medical implants.

In the US, breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in Europe. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the US. Nevertheless, the FDA track record on breast implants indicates that studies have provided limited information about safety.

The authors conclude that neither the European Union nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation.

To see the official summary: http://www.ncbi.nlm.nih.gov/pubmed/23245415