Tag Archives: safety

What Genentech is doing to fix biotech’s diversity problem

Fortune Editors, Fortune: April 7, 2021


There’s a big problem with clinical trials: a lack of diversity. And that issue is ultimately detrimental to countless people’s lives and health.

Take, for example, breast cancer research. For a long time, the thinking in the health care world was that Black women didn’t develop breast cancer as often as white women, but when they did, they were more likely to die because of it.

“There was this assumption that it was an issue of access to care, the quality of care,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank that analyzes the latest research and helps consumers and organizations put that information to work. But “if you looked at the research, you saw that the original major studies of breast cancer treatment were done on white women.”

That meant the research featured fewer women with triple-negative breast cancer, which Black women develop more often than white women. “Because [women with triple-negative breast cancer] weren’t studied,” Zuckerman continues, “[the researchers] didn’t realize that the treatments that they were studying would not work on those types of cancer.”

Zuckerman talks with Fortune’s Ellen McGirt on this week’s episode of Leadership Next, a podcast about the changing rules of business leadership. Also on the episode with McGirt and cohost Alan Murray is Alexander Hardy, who became CEO of biotech company Genentech two years ago.

Hardy has made it clear that he’s committed to boosting diversity within the biotech world and in clinical trials, and he was already doing so before the pandemic. But COVID-19 crystallized some of the issues in the U.S.

[….]

During the show, Hardy also discusses the ways the COVID-19 pandemic has changed the biotech industry, and how those changes could spill over into research on diseases such as Alzheimer’s, ALS, and cancer.

To read the entire article and listen to the podcast, click here.

Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL

Christina Bennet, MS, Cancer Therapy Advisor: February 8, 2021


Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field.

“There have been efforts made [to ensure patients are informed], but they have not been successful,” Diana Zuckerman, PhD, president of the National Center for Health Research (NCHR), said in an interview with Cancer Therapy Advisor.

The most recent effort to more frontally disclose the risk for BIA-ALCL is a final guidance document released by the FDA on September 28, 2020.1 The guidance, which applies to all breast implants, advised breast implant manufacturers to add a black box warning that mentions the risks associated with breast implants such as BIA-ALCL. In the guidance, the FDA also encouraged manufacturers to incorporate a patient decision checklist in the labeling to “better ensure certain information is received and understood by patients.”1,2 Manufacturers, however, are not required to follow these recommendations.

Zuckerman, who is a member of the Breast Implant Working Group, said she was surprised by the FDA’s decision to recommend rather than require these facets of the guidance. “We don’t have the answer to that question other than we have talked to FDA officials who said that at least some of this will at some point be a requirement, but we don’t know when that is,” she said.

With no mandates in place to ensure that patients receive information about the risks for BIA-ALCL—among other breast implant-associated complications—upfront, the industry is left to educate—and this does not seem to be working.

Patient advocates Terri McGregor and Jennifer Cook, both of whom have received a BIA-ALCL diagnosis, discussed a misleading patient brochure that has further contributed to the misinformation about breast implant-associated cancer risk. Sold online by the American Society of Plastic Surgeons (ASPS), the brochure featured the symbol for breast reconstruction awareness—a modified pink ribbon—and the slogan “Closing the loop on breast cancer.”3

The brochure was sponsored by several companies, including 2 prominent breast implant manufacturers, Allergan and Mentor. Though the document was promoted on Twitter by the ASPS and users were encouraged users to “stock up now” ahead of Breast Reconstruction Day,3,4  it notably made no mention of BIA-ALCL—not even on the page that describes the risks and safety issues associated with breast implants.

Conflicts of Interest Cloud Risk Disclosure

[…]

Eric Swanson, MD, a plastic surgeon at the Swanson Center for Cosmetic Surgery in Leawood, Kansas, told Cancer Therapy Advisor that plastic surgeons’ financial ties to breast implant manufacturers are part of the reason why they have been slow to respond to the issue of BIA-ALCL. “There’s a big problem with conflict of interest in plastic surgery. Once [a person has] taken funds from a company, it is very rare for the taker to be critical of that company,” Swanson said.

[….]

Zuckerman described the ASPS brochure as “terribly” out of date. “The Institute of Medicine report is more than 20 years old, and there has been a great deal of research since then,” she said.

[….]

The ASPS Brochure: Current Status

When Cancer Therapy Advisor inquired about the content of the brochure, an ASPS representative agreed that the information was “outdated” and removed the brochure from sale on its website.

Enclosed in the ASPS brochure was a list of websites that included breastimplantsafety.org, which—despites its domain name—did not include any safety information about breast implants. Instead, the domain redirected users to a different domain, smartbeautyguide.com, the patient site for The Aesthetic Society, a professional organization for plastic surgeons. A representative for The Aesthetic Society told Cancer Therapy Advisor that breastimplantsafety.org was active until 2015, when it migrated to their patient site, Smart Beauty Guide.

“We have been developing and will launch our new Aesthetic Society website that will include a dedicated section for patient education,” the representative wrote in an email. Within days of being contacted by Cancer Therapy Advisor, The Aesthetic Society updated the breastimplantsafety.org domain name to direct users to an existing page that provides resources about breast implants, including information about BIA-ALCL and breast implant illness, a systemic condition characterized by a wide range of symptoms that is currently under FDA investigation.18

Read the full article here

Alternatives to Breast Implants: Lifts and Fat Transfers


When considering cosmetic breast augmentation, women typically consider implants as their main option. However, there are several other procedures to change how your breasts look that may have fewer risks and complications compared to breast implants. These alternatives include breast lifts and fat transfers.

Breast Lifts

Breast lifts, clinically called a “mastopexy,” raise and reshape the breasts. Surgeons remove extra skin and tighten surrounding tissue. In addition to reshaping the breasts, a lift can reposition the nipple and reduce the size of the areola if it has become enlarged over time. Many women choose to get breast lifts to improve the stretching or sagging of their breasts that could have been caused by pregnancy, weight fluctuations, and simple gravity. A breast lift alone cannot make breasts larger, but breasts will look fuller and more perky after the procedure. 1

There are four types of breast lift techniques, which depend on breast and areola size and shape, degree of sagging, amount of skin that must be removed, and the elasticity of skin. For women who have smaller breasts or minor sagging, a crescent or donut technique can be used to create small incisions around the areola. For women who have larger breasts and more severe sagging, surgeons will need to create multiple incisions, either around the areola and vertically down the middle of the breast (a lollipop technique) or including a horizontal incision along the breast crease (an anchor technique). 2

Swelling and bruising will last for about two weeks, and numbness may last up to six weeks. Final results of breast lifts will appear over the months following the procedure as the breasts settle into their new shape and position. Results of a breast lift procedure are long-lasting, especially with a healthy lifestyle. Women with smaller breasts will likely have results that last longer than women with larger breasts. It is also important to note that the cosmetic appearance of the breasts can change due to pregnancy, breast feeding, and significant weight changes that occur after surgery. Therefore, women should consider whether they are planning a pregnancy in the near future before having a breast lift. 3

Risks of Breast Lifts 

When considering a breast lift, it is important to consider the risks of the procedures in addition to the benefits. For breast lift procedures, the most common risks include changes in nipple or breast sensation, asymmetrical breast shape, and partial or total loss of the areola.1 Less common risks that some patients experience are bleeding or hematoma formation, infection, poor incision healing, fat necrosis (fatty tissue around skin may die), and fluid accumulation. Although patients will have scars from a breast lift procedure, many notice that some scarring is hidden in natural contours of the breasts and that scars improve over time, typically within one year.3 As with any cosmetic procedure, some patients may be unhappy with the final result. Your chances of getting the results you want will be better if you choose a board certified plastic surgeon with a lot of experience doing breast lifts without breast implants.

Some plastic surgeons recommend getting both a breast lift and implants to get the best cosmetic result. However, that means patients will face the risks of the lift and the additional risks of the implants. While the breast lift procedure alone is safer than getting implants, there is still a lack of safety data and research on breast lifts to know how often complications occur in the solo procedure. The skill and experience of the plastic surgeon makes a big difference.

Fat Transfer

Fat transfers may be a good option for women who want to have more natural looking, fuller breasts without implants. Fat transfers use liposuction to remove fat from other parts of the body and insert it into the breasts. Fat for liposuction is typically taken from areas such as the back, thighs, abdomen, and buttocks. 4 Next, the fat cells are processed into a liquid so they can be injected into the breast area. 5 The surgeon will slowly inject the fat liquid to multiple areas of the breast until the desired breast size is achieved. Since the procedure uses body fat from the patient, thin women may not be good candidates for this procedure. Because the injected fat does not contain its own blood supply, only a small amount of fat can be injected at a time. Patients should not expect to gain more than one cup size. 

Patients typically notice improvement right after the procedure, but the final results will appear one year after surgery when swelling has gone down. Multiple follow-up fat transfer procedures may be necessary to maintain the shape of the breasts. In many cases, fat that has been injected into the breasts may be reabsorbed by the body over time, move to other parts of the body, or die, causing breasts to lose volume.5 Therefore, surgeons may recommend follow-up sessions to repeat the procedure, which may be expensive and is an important factor to consider.

Risks of Fat Transfers

High patient and surgeon satisfaction as well as low complication rates have been reported for fat transfer procedures, but outcomes vary greatly based on the surgeon as the procedure is not yet standardized. 6, 7 The most common complications from fat transfers include development of cysts (lumps) or fat necrosis, which is when the transferred fat dies and is reabsorbed by the body. 8 Fat necrosis is more common when a large amount of fat is injected. This usually does not need to be treated, as the body takes care of the dead cells on its own. 

Other less common complications can include infection and calcification of the fat.8 Like fat necrosis, these complications are more common when a large amount of fat is injected. Because the injected fat does not have its own blood supply, too much injected fat may lead to microcalcifications, which is when the fat hardens. These calcifications are usually harmless, but they may look like breast cancer on a mammogram, resulting in stressful and expensive breast biopsies.

Bottom Line

Despite risks, lifts and fat transfers appear to be safer than breast implants. Breast implants are not lifetime devices, and women should expect additional surgery to replace them every 10-15 years if not more often. Health insurance often does not pay for removal or complications for augmentation patients and never pays for replacement of cosmetic implants. The high cost of these additional surgeries, as well as the common complications from implants, make lifts and transfers a safer option for many patients.

While breast lifts and fat transfers provide alternatives to breast implants for cosmetic breast enhancement, patients must consider the risks of both procedures before choosing to undergo surgery. More long-term research is needed to confirm the safety and effectiveness of both procedures.

When deciding whether or not to undergo cosmetic breast augmentation, it is important to weigh the risks and benefits of each procedure with a highly skilled, experienced surgeon who is board certified in plastic surgery, so you can make a decision that is right for you. 

NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance

National Center for Health Research: December 13, 2018


Comment of the National Center for Health Research Regarding the
510(k) Third Party Review Program:
Draft Guidance for Industry, FDA Staff, and Third Party Review Organizations.
OMB Control Number 0910-0375

The National Center for Health Research (NCHR) is a non-profit organization which conducts original research to better inform policy makers, health professionals, and patients.   NCHR accepts no funding from any entity which manufactures or distributes medical products.

We appreciate the opportunity to comment on this draft guidance.  We note that this draft guidance applies to low-to-medium risk medical devices, which concerns us because many Class II devices are permanent implants that have the potential to cause permanent harm to patients.  In fact, our research indicates that even Class I devices have been subjected to high-risk recalls by the FDA due to the potential for causing death or permanent harm.1 2 3

We have several serious concerns about the draft guidance.  First, Original Equipment Manufacturers (OEM) are accountable for the efficacy and safety of their medical devices.  FDA standards require that devices manufactured by OEM’s comply with relevant regulatory standards.  OEMs are required to track, monitor, and report product issues to FDA.  Overseeing the OEMs and their reporting are FDA’s responsibility to ensure patient safety.

Second, in the past FDA has had the opportunity to review the work of any third party reviewer, and reject it if deemed inadequate or shoddy.  In fact, the agency has often found problems with the third party reviews.  The proposed guidance would sharply reduce the agency’s oversight of third party reviews, which will clearly compromise safety.  Even if certified as qualified, third party review companies have an inherent conflict of interest: If their standards are too high, no device company will hire them and they will go out of business.  The system is similar to the EU regulation of medical devices, which has resulted in very harmful decisions, such as the clearance of the PIP breast implants that were found to use non-medical grade silicone.4  In addition, investigative reporters recently obtained CE clearance for a “surgical” mesh that was made out of a plastic mesh bag used for oranges.

Transparency is also a crucial factor.  Currently, third party review companies are not required to clearly label an OEM device indicating that a critical repair has been completed by someone other than the OEM.  Once that repair is made, the device is no longer the same device that was approved or cleared by FDA.  It is important that this chain of accountability is not broken or interrupted.

While we understand the desire of FDA officials to reduce medical device review times and reduce the burden on FDA staff and industry, the 510(k) program already is a quick way to get devices to market and the device industry has clearly benefitted from it.  The 510(k) pathway has been widely criticized by the Institute of Medicine, physicians, patients, and the media for its lack of clinical trials and lack of scientific evidence.5  Despite its weaknesses, the 510(k) pathway is considered superior to the EU regulatory system, however.  By reducing the “burden” for FDA staff and industry, the proposed guidance increases the burden on patients and doctors to figure out which devices are safe and which are not.  This would clearly put U.S. patients at greater risk.

FDA has not demonstrated that its proposed changes to the third party review pathway of Class I and Class II devices will benefit patients.  By definition, 510(k) devices only rarely are substantially superior to recent predicates.  Speeding up the process of clearance is not demonstrated to benefit patients.  Moreover, with registries, NEST, and other planned efforts to improve post-market surveillance still far from effectively implemented, any loosening of 510(k) regulations is very premature.

Finally, we note that Commissioner Gottlieb responded to recent media criticism of CDRH regulations by promising improvements to the 510(k) pathway to ensure patient safety.  The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices.   We strongly oppose it for that reason.

 

References

  1. Zuckerman, D.M., Brown, P, and Nissen, S.E.  (2011) Medical Device Recalls and the FDA Approval Process, Archives of Internal Medicine, 117, 1006-11.
  2. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(11), 1045.
  3. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(21), 1963.
  4. Zuckerman, D., Booker, N, and Nagda, S. (2012) Public Health Implications of Difference in US and European Union Regulatory Policies for Breast Implants, Reproductive Health Matters, 20 (40),102-111.
  5. Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices,  JAMA Internal Medicine, 174(11): 1781-1787.

 

Women’s Health Advocates Question FDA About Missing Safety Data on Silicone Breast Implants

Matthew Perrone, Associated Press: January 5, 2012.

[…] FDA concluded last summer that the silicone-gel implants are basically safe as long as women understand they come with complications. More than one in five women who get implants for breast enhancement will need to have them replaced within five years, the agency’s report concluded.

In August, an outside panel of physicians affirmed the FDA’s decision that the devices should remain available for both breast enhancement and reconstruction.

But the National Research Center for Women and Families says the FDA did not present information that showed women reported lower emotional, mental and physical well-being after implantation. Additionally, the group questions why figures presented by the FDA appear to show implant complications declining over time. The implants are known to fail over time.

“This shows problems with the data, since the complication rates are reported to be cumulative and should therefore stay the same or increase over time,” states Diana Zuckerman, the group’s president, in a letter to the head of FDA’s medical device division.

Most of the FDA’s data on the safety and effectiveness of breast implants comes from long-term studies conducted by the two U.S. manufacturers of the devices, Allergan Inc. of Irvine, Calif., and Mentor, a unit of Johnson & Johnson, based in New Brunswick, N.J.

When the FDA reviewed the initial applications for the devices in 2005, women using Allergan’s implants scored lower on nine out of 12 quality-of-life measures, including mental, social and general health. Women did report higher scores on measures of sexual attractiveness-body esteem.

Women implanted with J&J’s implants also scored worse on measures of physical and mental health. In the 11-page letter, Zuckerman questions why that information was not presented at FDA’s public meeting in August.

“Breast implants are widely advertised and promoted as a way to increase women’s self-esteem and positive feelings about themselves,” said Zuckerman, in an interview with the Associated Press. “But the implant companies’ own data, which the FDA made public in 2005 but ignored last year, shows the opposite.” […]

Breast implants are known to rupture and break down over time. But Zuckerman points out in her letter that the company data seem to defy this trend, with complication rates falling over time.

For instance, Allergan’s reported rate of swelling among patients fell from 23 percent in 2005 to 9 percent reported in 2011. Rates of scarring similarly fell from 8 percent to 4 percent.

“This again raises questions about the accuracy of reporting, and whether patients with complications were excluded from the 10-year sample,” writes Zuckerman. […]

 

Read the original article here.

F.D.A. Affirms Safety of Breast Implants

Gardener Harris, The New York Times: August 31, 2011.

WASHINGTON — After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants.

The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe. […]

Some patients and women’s groups who testified at the meeting disagreed.

Diana Zuckerman, president of the National Center for Health Research, a research and education group, told an expert panel that the two companies that manufacture silicone breast implants — Johnson & Johnson and Allergan — had done a poor job of studying patients who got the implants, as the F.D.A. required them to do.

“And without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes,” Ms. Zuckerman said. […]

There was some criticism of the 27-page research form that patients who participate in the study are required to complete and whether it could be shortened. Nearly all expressed hope that a registry could be created that would follow all breast implant patients, but such registries are expensive to maintain and complicated to create. […]

Read the original article here.

Women’s Health: A Red-Flag Warning

Seattle Post-Intelligencer: January 12, 2007

We’ve never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.

Restricted since 1992, the implants were deemed unsafe because of the health risks associated with them, such as cancer. The FDA currently recommends that only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. and Mentor Corp., to carry out a 10-year, 80,000-patient study in order to “fully answer important questions” regarding the products safety. […]

We spoke to two experts on the matter: Diana Zuckerman, president of the National Research Center for Health Research at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University’s School of Public Health. The two scientists want you to know a few things:

 Post-approval studies are common, but the sheer scope of this one should be a red flag. Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.

 Although you can pay for the implants in installments, you can’t do so for their removal — and they will need to be removed or replaced. Health insurance seldom covers those additional surgeries.

 You’ll need to get pricey MRIs regularly. And no, your insurance probably won’t cover them.

 By no means should you take the FDA’s approval of the implants to mean that they’re safe. For example, their effect on breast milk, says Zuckerman, has “never, ever, ever been tested” by the FDA. […]

Read the original article here.