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A Valuable Tool Against Chronic Hepatitis B Goes Unused in Many Developing Countries

Image courtesy of tuelekza at FreeDigitalPhotos.net.
Image courtesy of tuelekza at FreeDigitalPhotos.net.

By Christine Kukka

A critical tool that stops the spread of nearly half of all new chronic hepatitis B infections is still unavailable in many developing countries – the hepatitis B vaccine birth dose.

When the hepatitis B vaccine is immediately administered to a baby born to a hepatitis B-infected mother, it stops the terrible spread of hepatitis B to a new generation.

But this vaccine remains unavailable and financially out-of-reach for many parents in rural areas of Africa, Asia and other regions.

“In Ghana, even if parents know where to find the vaccine, the cost sometimes deters them from accessing it,” said Theobald Owusu-Ansah of the Hepatitis B Foundation of Ghana.   “And when midwives help mothers deliver their babies in their homes, they do not have the vaccine with them because it must be refrigerated.”

While a global childhood immunization program, sponsored by the global vaccine alliance GAVI, has saved millions of lives, the hepatitis B birth dose remains a critical, missing piece of its otherwise successful global immunization strategy.

Image courtesy of africa at FreeDigitalPhotos.net.
Image courtesy of africa at FreeDigitalPhotos.net.

To effectively prevent mother-to-child (perinatal) transmission of hepatitis B, the single-dose hepatitis B vaccine must be administered within 12 to 24* hours of birth. In about 90 percent of cases, this vaccine effectively prevents infection, unless the mother’s viral load is extremely high.**

Today, GAVI funds and promotes the pentavalent vaccine, which prevents five diseases including hepatitis B, for nearly all children in developing countries. But here’s the catch, the earliest the first dose of the pentavalent vaccine can be administered is six weeks of age because it contains the diphtheria vaccine. This is far too late to prevent perinatal hepatitis B infection.

GAVI’s pentavalent vaccine makes economic and medical sense. One vaccine that prevents several diseases lowers manufacturing and shipping costs and requires fewer injections. Indeed, widespread immunization with GAVI’s pentavalent vaccine in 73 developing countries has prevented 7 million deaths, but it doesn’t prevent chronic hepatitis B acquired at birth.

The World Health Organization (WHO) has made eradication of hepatitis B by 2030 a major goal, but it is unattainable unless perinatal infection is prevented.

Without GAVI’s financing or promotion of the hepatitis B birth dose, many developing countries have done little to promote the birth dose, despite their high rates of hepatitis B. According to the WHO, in 2015, 8.4 million babies were born in African countries that did not provide the birth dose of the hepatitis B vaccine.

In addition to a lack of political will on the part of GAVI and these countries, there are other barriers to distributing the hepatitis B birth vaccine. As Owusu-Ansah explained, about one-third of births in his native Ghana  and about 45 percent of all births in Africa take place without a healthcare worker or midwife present.

Volunteers from the Rann India Foundation teach villagers about hepatitis B testing and prevention in India.
Volunteers from the Rann India Foundation teach villagers about hepatitis B testing and prevention in India.

Suren Surender, founder and president of the Rann Bhoomi Foundation, which educates rural villagers in India about hepatitis B prevention, added that even when healthcare workers are present at childbirths, “there is a lack of knowledge about birth dose administration and there is also a lack of community awareness about the benefits of getting the birth dose.”

Having a global leader like GAVI lend financial and strategic support for the hepatitis B birth vaccine would go far to chip away at these high perinatal infection rates in rural regions. In 2013, GAVI and the global vaccine alliance explored funding the hepatitis B birth dose as part of its Vaccine Investment Strategy (VIS),  but officials decided not to fund it.

According to a GAVI spokeswoman, the key deterrent was implementation — getting the refrigerated vaccine birth dose to rural areas within hours of a child’s birth – rather than cost.

“Many births in GAVI-supported countries do occur outside health facilities,” she noted. “Indeed, coverage of hepatitis B birth dose in many countries delivering this intervention is low. Ultimately, the Vaccine Investment Strategy analysis and consultations recommended that (GAVI) should focus its limited resources on other high-impact vaccines at the time.”

However, research suggests the hepatitis B vaccine may be effective for several days or weeks in warm climates without refrigeration, which could increase their use in rural regions if there was more financial and political support.

In 2018, GAVI will reconsider potential support for the hepatitis B birth dose when it develops a new Vaccine Investment Strategy, with a decision expected in late 2018.

GAVI’s support for the birth vaccine is needed immediately. Only GAVI has the resources and political clout to help countries realign their immunization policies to allow the next generation of children born to hepatitis B-infected parents to live without liver disease.

*North American medical guidelines recommend the first hepatitis B vaccine dose be administered within 12 hours of birth, while WHO recommends the vaccine be given within 24 hours of birth.

**The addition of a dose of HBIG (hepatitis B antibodies) along with the vaccine raises the prevention rate a few percentage points. However, the vaccine alone is highly effective.

Kate Moraras: Making Sure Federal Policies Work to Eliminate Hepatitis B Locally

Kate Moraras, Hepatitis B Foundation senior program director and Hep B United director.
Kate Moraras, Hepatitis B Foundation senior program director and Hep B United director.

By Christine Kukka

It’s Kate Moraras’ job to make sure federal programs crafted in the elite halls and federal agencies of Capitol Hill are what’s really needed to eliminate hepatitis B in Asian-American, African and other at-risk communities across the country.

Simply put, her goal is to eradicate, “the most staggering health disparity facing immigrant communities.”

The people on whose behalf Moraras works are among the most vulnerable and powerless in the country. They include Asian-American and Pacific Islander (AAPI) and African immigrants who were infected at birth or by contaminated syringes or medical tools in their countries of origin.

As senior program director at the Hepatitis B Foundation and director of the Hep B United national coalition for the past three years, Moraras has worked with federal officials and dozens of hepatitis community advocates across the country to align federal policy with the need of diverse, hard-to-reach communities.

“I have always been drawn to systems-level change and I saw public health policy as a key area where there are opportunities to make an impact,” she explained. She was energized by the prospect of finding solutions that would improve healthcare at the individual and community level, and she obtained her master in public health at George Washington University.

After graduation, Moraras learned about hepatitis B when she was working on AAPI health disparities in the federal government. “Then, my uncle found out he had chronic hepatitis B when he tried to donate blood,” she recalled. Suddenly, what had been a matter of political injustice became a personal cause and she began working at the foundation.

Moraras knows federal policies don’t succeed unless they make a difference on the streets of America. “Grassroots and culturally-focused organizations are pivotal to eradicating hepatitis B because they know their communities and how they are at risk of hepatitis B,” she explained.

Preventing and treating hepatitis B in immigrant communities requires cultural nuance. Each community has its own language, cultural practices and healthcare beliefs. Many lack insurance coverage and when they finally reach a clinic or doctor’s office, the cultural disconnect creates an insurmountable barrier to learning about this complex disease.

This is why having local organizations whose staff know the culture, speak the language and can bridge the glaring healthcare gap that now stops people from getting vaccinated and treated for hepatitis B is key. “Their communities trust them, which is so critical when it comes to navigating healthcare and communicating accurate information about hepatitis B, a disease that is stigmatized in many AAPI communities. If we want to eradicate hepatitis B in the U.S., we must partner with local organizations and make sure they have adequate resources to do the job.”

Hep B United and the foundation are working to make sure federal policy helps, rather than hinders, these vital, local initiatives.

“Fortunately, we have had champions within the federal government who have taken the opportunity to lead national efforts to address hepatitis B — for example, former Assistant Secretary for Health Dr. Howard Koh who led the development of the National Viral Hepatitis Action Plan and a White House Initiative tasked with specifically focusing on AAPI communities, with a cross-cutting voice and broad reach,” she said.

“CDC now has a multilingual communications campaign, the Know Hepatitis B campaign, to encourage hepatitis B testing among AAPI communities with educational materials in a variety of Asian languages,” she added. At state and local levels, there have been city councilors and state legislators who have become champions who advocate for funding for effective community programs to increase public awareness.

“What remains challenging is the disconnect between local groups providing direct services to people and federal agencies that are working to make and implement policy at the 30,000-foot level,” she said. “For example, we still do not have a national surveillance system to monitor chronic hepatitis B cases and trends and there remains an overall lack of awareness and attention to hepatitis B at the national level. We must all continue to ask for real investment by the federal government to combat hepatitis B.

“We need to build a national hepatitis B grassroots movement, which is something that I would like to see happen through my job and Hep B United in the years ahead,” she added. “We have built a strong coalition that continues to expand every year, we have powerful advocates from local communities who have taken on leadership roles in national hepatitis advocacy and I would like to see our movement continue to grow and translate to the millions of individuals we have the potential to reach.”

Hep B United is a national coalition to address and eliminate hepatitis B, a serious liver infection that is the leading cause of liver cancer.  An estimated 2 million people in the United States are chronically infected with the hepatitis B virus.  Hep B United aims to meet this public health challenge by increasing hepatitis B awareness, testing, vaccination and treatment.

Global Researchers Brainstorm Solutions in the Search for a Cure for Hepatitis B


Hepatitis B Foundation Expert Timothy Block Predicts Transformational New Therapies for Hepatitis B

Hepatitis B Foundation President Timothy Block
Hepatitis B Foundation President Timothy Block

By Christine Kukka

For more than 25 years, Timothy Block, Ph.D,, has worked tirelessly to find a cure for hepatitis B, promoting research, writing papers, mentoring students and collaborating with experts around the world to find a cure for the 240 million people living with this deadly liver disease.

Today, the cofounder and president of the Hepatitis B Foundation, the Baruch S. Blumberg Institute and the Pennsylvania Biotechnology Center, is optimistic and believes there are new therapies in sight for those living with chronic hepatitis B.

An unprecedented number of researchers are scrutinizing every stage of the hepatitis B virus (HBV) replication cycle to find its vulnerabilities and develop drugs to permanently disable it. The cure Block wants would completely eradicate the infection so no one would ever wake up worrying about the risk of liver damage or cancer to themselves or a loved one.

This global, active march towards a cure is in stark contrast to 1991 when Block began his solitary quest, after a friend’s devastating hepatitis B infection made him rethink his career and start focusing on the liver disease that infects more than one in three people worldwide.

Twenty-five years ago, the only available treatment was conventional interferon, which was largely ineffective. The first antiviral, lamivudine, appeared shortly thereafter. It would be one of several to emerge from HIV’s drug arsenal. Since then, more antivirals designed to disrupt HBV’s replication process have been developed that target the polymerase—the essential enzyme needed for HBV replication.

“But they are not cures,” Block explained during a recent webinar. “They’re good at reducing viral load (HBV DNA), but they don’t get rid of the virus, and considerable viral DNA and  hepatitis B surface antigen (HBsAg) remain in liver cells.” Nor do current antivirals get rid of the HBV chromosome called cccDNA that embed in liver cells and stubbornly remain, ready to churn out more virus if a person stops taking antiviral drugs, or if their immune system weakens due to advancing age or another illness.

There are other roadblocks that make hepatitis B far harder to cure than hepatitis C. HBV generates massive amounts of HBsAg that appear to overwhelm the immune system’s B cells, whose job is to produce antibodies to eradicate HBV’s antigens. When newborns or young children are infected, these B-cells become paralyzed or “exhausted” by the flood of HBsAg engulfing them and they don’t generate the antibodies needed to fight infection. In contrast, when healthy adults are infected, these B-cells act quickly and aggressively to eradicate HBsAg within six months.

“Now for the first time, we’re looking beyond the polymerase to find more targets that are essential for HBV replication,” Block explained. HIV researchers have already done this and have identified more than 30 different “targets” in the HIV replication process. Hepatitis B researchers are also expanding their target range.

There are now new drugs in development, some have even reached Phase II clinical trials, that target new HBV reproductive terrain. They employ a variety of strategies ranging from immune system enhancers to molecular weapons designed to halt cccDNA integration into liver cells.

“If you can suppress cccDNA, the game would be over,” Block said, “but cccDNA is small, tough target. It’s so small compared to other material, that it’s almost impossible to distinguish from other molecules.” However, biologicals that are able to “inhibit” or block cccDNA from entering a liver cell could stop the virus from hijacking and reproducing in liver cells. Here are some types of drug strategies currently in development that could lead to a cure:

Restructured versions of tenofovir: There are two new tenofovir “prodrug” compounds, called TAF and CMX 157, that are more effective at reaching liver cells and impeding HBV replication. TAF is now in Phase III clinical trials and is expected to reach the U.S. Food and Drug Administration (FDA) this month (November 2016).

Molecular agents that target and disable HBV replication:

  • A new agent, called the CRISPR/Cas9 system, may be able to operate on a molecular level to search out and destroy HBV cccDNA molecules.
  • One of the more advanced molecular strategies, already in Phase II trials, is a “silencing” RNA process. This approach uses RNAi gene silencers to target and destroy HBV RNA to prevent viral reproduction. “CccDNA remains,” Block explained, “but all of its gene products it needs are choked.”

Entry inhibitors: Some of these drugs resemble HBsAg, but they work as decoys to prevent the virus from entering or binding to the liver cell. One is in Phase II clinical trial.

Capsid inhibitors: This approach interferes with the viral DNA’s ability to connect or glue together during the replication process. Several of these drugs are in Phase II clinical trials.

HBsAg inhibition and eradication: “There are 1 million more HBsAg as the actual virus,” Block observed. “Why are there so many? What is it doing in the blood? Why is it able to exhaust our B-cells?” Because HBsAg appears to hold a key in stopping infection, researchers are working to develop a way to eradicate HBsAg. Two of these HBsAg eradicator products are in Phase II trials.

Adaptive and innate host defense: This approach involves a two-step strategy, first reducing viral load to undetectable levels by helping liver cells become “in-hospitable” hosts to HBV’s reproductive efforts, and then introducing a vaccine or some other immune enhancer that can break the B-cell exhaustion cycle while firing up immune cells to aggressively fight and eradicate the infection. There are several of these drugs in Phase I and II clinical trials.

Block told his webinar audience that ideally one of these drugs would emerge as a single, simple cure. “But every infectious disease today, such as hepatitis C and HIV, is almost always treated with a combination of drugs. We might see two direct-acting antivirals and maybe a third drug that work as an immune system activator.”

When asked which patients would get first access to a new cure, Block predicted that people with high viral loads and liver damage would be treated first based on medical need. “As drugs get safer, I hope we will  treat people in the immune tolerant phase (with high viral load but no signs of liver damage yet), before they begin to have signs of liver damage.”

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Know Hepatitis: Reduce Liver Cancer Risk and Join a Liver Cancer Awareness Twitter Chat Oct. 25

October is Liver Cancer Awareness Month and it’s time to “chat” about reducing liver cancer in people living with hepatitis B and C.

On Tuesday, Oct. 25, representatives from Hep B United, CDC’s Division of Viral Hepatitis, and NASTAD (the National Alliance of State and Territorial Aids Directors) will co-host a twitter chat at 2 p.m. EST using the hashtag #liverchat.

Also participating are special guests from CDC’s Division of Cancer Prevention and Control, Prevent Cancer Foundation, and Dr. Katherine McGlynn of the National Cancer Institute. Dr. McGlynn is a Senior Investigator at the National Cancer Institute, Division of Cancer Epidemiology & Genetics, Metabolic Epidemiology Branch. She is a researcher and expert in hepatocellular carcinoma.

Below are questions scheduled to be discussed during the chat. How can you contribute to the conversation? Share any resources or strategies you have that raise awareness about liver cancer. Join the conversation with the hashtag #liverchat.

Q1: What is liver cancer and why is it so deadly?

Q2: What are the risk factors for liver cancer and why should people viral hepatitis worry?

Q3: What are some strategies to help prevent viral hepatitis and liver cancer?

Q4: What are the barriers that keep people from getting screened for viral hepatitis and how can they be addressed?

Q5: What can people living with chronic hepatitis B and C do to protect their liver health and prevent liver cancer?

Q6: Why are some populations more vulnerable to viral hepatitis and liver cancer, and how do we address the disparities?

Q7: What can we do to raise awareness & educate vulnerable communities about viral hepatitis and its link to liver cancer?

Q8: What resources are available to learn more about viral hepatitis and liver cancer?

Co-hosts and special guests for the chat include:

  • Hep B United – @HepBUnited
  • NASTAD – @NASTAD
  • CDC Division of Viral Hepatitis – @cdchep
  • CDC Division of Cancer Prevention – @CDC_Cancer
  • Dr. Katherine McGlynn – @LiverCancerConn
  • Prevent Cancer Foundation – @PreventCancer

Confirmed participants and their handles include:

  • Hepatitis B Foundation – @hepbfoundation
  • CDC National Prevention Information Network (Twitter chat moderator) – @CDCNPIN
  • White House Initiative on Asian Americans and Pacific Islanders @whitehouseaapi
  • Hep B United Philadelphia – @HepBUnitedPhila
  • Coalition Against Hepatitis For People of African Origin – @CHIPO_HBV
  • Asian American Community in Action – @apcaaz
  • Assn. of Asian Pacific Community Health Organizations (AAPCHO) – @HepBPolicy
  • National African Immigrant and Refugee HIV/AIDS and Hepatitis Awareness Day (NAIRHHDay) – @NAIRHHADay
  • Hep Free NYC – @HepFreeNYC
  • Asian Health Coalition – @aapinews
  • Thelma Thiel – @theLiverLady
  • Charles B Wang Community Health Center – @CBWCHC
  • Office of HIV/AIDS & Infectious Disease Policy – @HHS_ViralHep
  • Hope Clinic – @AAHC_HOPEClinic
  • World Hepatitis Alliance – @Hep_Alliance
  • National Viral Hepatitis Roundtable – @NVHR1

Just getting started with Twitter? Want to know how to join the conversation?  Type #liverchat in the search box of the Twitter application to follow the chat. You can prepare your tweets in response to the topics listed above in advance, or you can also tweet on the fly, re-tweet, or Like a tweet from the chat.

The questions are labeled Q1, Q2, etc. so please respond/answer specific question by using A1, A2, etc. in front of your tweets. Remember to include the #liverchat hashtag, which is not case sensitive, in all of your tweets.

If you plan to participate, please contact us at info@hepb.org and we’ll add you to the list of confirmed participants. Let us know if you have any other questions about joining the chat.

Why Raised Voices, Phone Calls and Letter Writing Are Critical to Eradicate Hepatitis B

2013-05-17_HepbUnitedEventBy Christine Kukka

Getting the medical care we need requires advocacy, because in the U.S. the quality of our healthcare–and even how long we live–depends on our income, ethnicity, gender and where we live. That is especially true when we live with hepatitis B.

Many affected by hepatitis B are not endowed with money, privilege or political power. Most of us are immigrants and people of African and Asian descent. This infection illuminates our country’s racial divides in healthcare. Asian-Americans, for example, have liver cancer rates 13-times higher than white Americans because they were never tested for hepatitis B, diagnosed or treated until it was too late.

Many of us are gay or injecting drug users. We are often uninsured or under-insured, which leaves us unable to pay for testing or treatment.

Our doctors, who often work in healthcare systems focused more on the bottom line than patient care, see too many patients in too little time. They may not know to screen us for hepatitis B, or monitor us properly and refer us for treatment when the infection damages our livers.

Despite good intentions, we live with a broken healthcare system and like any political system it requires the actions of patients, voters and advocacy organizations to improve.

Participants Perform a B A Hero Chant
Participants Perform a B A Hero Chant

The Hepatitis B Foundation and national coalitions including Hep B United are working within the political system to make healthcare more equitable and accountable.  They’re fighting to get more funding so the U.S. Centers for Disease Control and Prevention and the National Institute of Health have more resources to eradicate hepatitis B. Recently, these advocates scored a victory. Continue reading "Why Raised Voices, Phone Calls and Letter Writing Are Critical to Eradicate Hepatitis B"

Hepatitis B Foundation: Answering Questions and Dispelling Fears One Call or Email at a Time

Maureen Kamischke, Hepatitis B Foundation's social media and outreach manager.
Maureen Kamischke, Hepatitis B Foundation’s social media and outreach manager.

Hepatitis B is a complex infection, it can impact our health, lifestyle choices and threaten relationships. Sometimes, we need to ask for help.

One of the most personal and valuable services the Hepatitis B Foundation provides is answering individuals’ emails and phone calls about hepatitis B. These queries, which can come from all over the world, often involve discrimination, disclosure and how to interpret lab tests that baffle inexperienced doctors and nurses.

One of the people at the foundation who answers these emails and calls is Maureen Kamischke, the foundation’s social media and outreach manager. Kamischke, whose daughter had hepatitis B, knows first-hand the difficulty of finding healthcare providers with expertise in hepatitis B treatment. She has grappled with decisions about disclosing her child’s infection at school and to friends. Today, she continues to advise her daughter (now an adult) about her liver health, and she also answers the dozens of emails and calls that reach the foundation each week.

Maureen Kamischke's daughter Maren.
Maureen Kamischke’s daughter Maren.

Today, guided by decades of personal and professional hepatitis B experience, Kamischke helps others navigate the challenging world of hepatitis B. “My goals are to disseminate accurate information, provide hope and information that will empower people living with hepatitis B to make simple lifestyle changes that will help them feel like they have some control over their lives,” she explained. “I understand that the disease will shape them, but I want them to understand it should not define or limit them. “ Continue reading "Hepatitis B Foundation: Answering Questions and Dispelling Fears One Call or Email at a Time"

World Hepatitis Day: Because 4,000 Deaths a Day Is 4,000 Too Many


save-7-million-lives-2-212x300By Christine Kukka

The World Health Organization has designated July 28 as World Hepatitis Day, a day to work for global change to eliminate viral hepatitis and the suffering, death and discrimination that accompanies hepatitis B and C by 2030.

From Asia to North America, on this day people around the world raise awareness about viral hepatitis and advocate for better access to treatment and prevention programs and more effective government action. Why? Because 4,000 deaths a day from viral hepatitis is 4,000 deaths too many.

This action is critical, because for too long global leaders have made hepatitis a low priority. Viral hepatitis is a silent disease that causes no symptoms until it’s too late, and many believed the hepatitis B vaccine would simply make the infection go away.

Instead, global health organizations focused on other diseases such as HIV/AIDS, tuberculosis and malaria. HIV especially benefited from unprecedented efforts and donated resources to enable diagnosis and prevention of transmission and to provide treatment at low cost.

Today, we need the same effort and resources to eradicate viral hepatitis, which kill an estimated 1.4 million each year – more people  die from hepatitis annually than from HIV/AIDS and tuberculosis combined.
no-hep-for-all-2-212x300For example, between 5 to 20 percent of the 1 billion people living in Sub-Saharan Africa have chronic hepatitis B Despite this prevalence, there are no widespread screening, education or prevention programs in Africa. The majority of people lucky enough to get screened and diagnosed for hepatitis B are often blood donors, because there are no public health clinics that provide screening for viral hepatitis.

In Asia and Africa, even when pregnant women are diagnosed with hepatitis B, their newborns are often not given that critical, first vaccine dose within 12 hours of birth that would break the mother-to-child hepatitis B infection cycle. The birth dose of the hepatitis B vaccine is either too costly or simply unavailable. Perinatal infection, though preventable, continues to be a major source of chronic infection worldwide. Continue reading "World Hepatitis Day: Because 4,000 Deaths a Day Is 4,000 Too Many"

Is a Cure for Hepatitis B Coming? Experts Say Yes

How far are we from finding a cure for hepatitis B? We are close, said Timothy Block, PhD, president and co-founder of the Hepatitis B Foundation and its research arm, the Baruch S. Blumberg Institute. He points out that hepatitis C, once thought to be incurable, is today cured with new combination treatments.

Image courtesy of suphakit73 at FreeDigitalPhotos.net.
Image courtesy of suphakit73 at FreeDigitalPhotos.net.

Experts believe a cure for hepatitis B will also soon be developed. And the need for a cure has never been greater, with more than 240 million people worldwide living with chronic hepatitis B, causing 1 million deaths per year from related liver failure and liver cancer.

“Treatments are available,” explained Block, “but we have become a little too comfortable with the medications that are currently approved for use.” While these drugs are effective, interferon has many side effects and daily antivirals require lifelong use. These drugs work in only half of the infected population and reduce death rates by only about 40 to 70 percent.

What will a cure look like?

The available antivirals are similar and combining them offers no advantage. They have limited effectiveness against cccDNA, the seemingly indestructible “mini-chromosome” of the hepatitis B virus that continues to produce virus particles in infected liver cells, even in people being treated. A cure, therefore, would have to destroy or silence cccDNA and provide long-term immunity. Because one-drug treatments can lead to drug resistance, a cure would almost certainly involve combination therapy, similar to hepatitis C. Continue reading "Is a Cure for Hepatitis B Coming? Experts Say Yes"