Drug company CEO hangs up on charity head who called with offer to pay $50,000 for life-saving treatment for a dying 7-year-old boy

– the company received $72 million in federal funding to develop Brincidofovir

  • The CEO of  pharmaceutical company that could supply a life-saving anti-viral drugs to a 7-year-old cancer sufferer refuses to hand the drugs over
  • Chimerix chief Kenneth Moch hung up on charity that offered to pay $50,000 for Josh Hardy’s treatment
  • Hung up when asked if he would react the same if it was his own son
  • Hardy, seven, is battling a viral infection following a bone marrow transplant
  • A drug called Brincidofovir made by North Carolina company Chimerex could clear up the infection in two weeks
  • Brincidofovir has not received FDA approval but has been administered for ‘compassionate use’ to hundreds of patients
  • Chimerex CEO Kenneth Moch says the company no longer has a compassionate use program because it cannot afford it

By James  Nye and Alex Greig

PUBLISHED:          17:13 EST, 11 March 2014       | UPDATED:          19:06 EST, 11 March 2014

Denial:  Chimerix CEO Kevin Moch has refused to supply 7-year-old cancer sufferer Josh Hardy with the life-saving anti-viral drug he needs

Denial:  Chimerix CEO Kevin Moch has refused to supply 7-year-old cancer sufferer Josh Hardy with the life-saving anti-viral drug he needs

The CEO of a drug company that is refusing to supply lifesaving medication to a seven-year-old cancer survivor from Virginia hung up the phone to a charity that offered to buy it for the little boy.

Chimerix chief Kenneth Moch put down the phone on Richard Plotkin, vice chair of the Max Cure Foundation after he offered to pay the $50,000 needed to secure Brincidofovir – needed to help Josh Hardy fight off an infection he developed after a bone marrow transplant.

‘I spoke to Mr. Moch yesterday by phone.  I told him that we had the $50,000 that I thought he was claiming he needed to supply the drug,’ Richard Plotkin, vice chair of the Max Cure Foundation, said on Tuesday morning’s Fox and Friends.

‘He then told me it isn’t about money.  He told me it’s all about ethics.  I said, ‘Fine, tell me why you will not give it to this little boy.

‘If he does not get the drug, he will die this week, I’m told.  He said he cannot make an exception.’

Plotkin asked Moch what he would do if Josh was his child or grandchild, but Plotkin said Moch refused to answer this question and then hung up the phone.

‘As a result, it appears the final plea is to the board of directors at Chimerix…I ask the board to close their eyes, and as you close your eyes, assume there’s a little boy lying in a hospital bed who says to his father, ‘Daddy, am I going to die? And if I’m going to die, who will take care of me in heaven?’’ Plotkin said to Fox and Friends. Continue reading “Drug company CEO hangs up on charity head who called with offer to pay $50,000 for life-saving treatment for a dying 7-year-old boy”

Swine flu pandemic media pundits with pharma links more likely to talk up risks and promote drugs

Contact: Stephanie Burns sburns@bmj.com 44-020-738-36529 BMJ-British Medical Journal

 

Competing interests should be declared — and reported — to maintain credibility of public health, say researchers

Academics with links to the pharmaceutical industry were more likely to talk up the risks of the 2009-10 swine flu pandemic in the media and promote the use of drugs than those without these ties, finds research published online in the Journal of Epidemiology and Community Health

During the 2009-2010 swine flu pandemic, the UK spent an estimated £1 billion on pharmaceuticals, including antiviral drugs (neuraminidase inhibitors) and an H1N1 specific vaccine.  Pharma made £4.5-6.5 billion out of H1N1 vaccines alone.  

Concerns were subsequently raised about the links (competing interests) experts on influential scientific advisory committees, including the WHO’s Emergency Committee, had with drug companies. 

Researchers retrospectively analysed UK newspaper print coverage of the HIN1 swine flu pandemic, to assess the extent of competing interests among sources quoted on the topic between April and July 2009—the period when major decisions were being made about how best to respond to the emerging threat. 

Daily, Sunday, tabloid, middle market, and broadsheet publications on both sides of the political spectrum were included, to reflect a range of perspectives and reporting styles. Broadcast media were excluded on the grounds that print media offered more in-depth analysis and more divergent viewpoints. 

The final sample of 425 articles was scrutinised for the sources quoted, the assessment of the risk to the population made by each source, and the promotion or rejection of drugs/vaccines. 

Competing interests for each named academic quoted were then unearthed, using conflict of interest statements, funding sources detailed on profile pages, Google searches, and funding declarations on all publications in the previous four years. 

Grants, honoraria, speakers’ fees, consultancies, advisory roles, employment, and directorship/stock ownership were all considered competing interests. 

The analysis showed that during the study period, health ministers were the most frequently quoted source (34%) in media articles on swine flu, followed by academics (30%). Sixty one academics were quoted, 18 (30%) of whom had competing interests. 

The academics made 74 risk assessments, over half of which (44; 59.5%) were higher than those made by official agencies, such as the Department of Health, in the same article.  

Of these, 35 were made by academics with competing interests, meaning that risk assessments from these academics were almost six times as likely to be higher than those from official agencies, compared with risk assessments made by academics without any industry links. 

Twenty academics commented specifically on drugs/vaccines in 36 articles (8.5% of the total). Half of them had competing interests—a higher proportion than the one in three on the WHO’s Emergency Committee. 

Half of the commentators promoted the use of antiviral drugs and around half (45%) promoted the use of a vaccine. Some 15% promoted both. 

Academics promoting the use of antiviral drugs in newspaper articles were eight times more likely to have pharma industry links than those not commenting on their use.  

Only three articles out of the 425 mentioned that the quoted academic had a potential competing interest. 

The researchers acknowledge that the interviews may have contained more nuanced views than appeared in print, and that journalists may have sought divergent views to balance a story or increase its newsworthiness.

But academics are a trusted and accessible source of comment for journalists and are in a unique and powerful position during emerging public health threats, they say.

“Our results provide some evidence that the provision of higher risk assessments and the promotion of [antiviral drugs] are associated with [competing interests] among academics,” they write. 

“These add to the growing body of literature highlighting the potential influence of the pharmaceutical industry on policy decisions through multiple avenues, including advisory committees, drafting of guidelines, and media commentary,” they note.

“Undisclosed [competing interests] degrades public confidence in medical research, to the detriment of the whole scientific community,” they write, concluding: “Academics should declare, and journalists report, relevant [competing interests] for media interviews.”

Commenting on the research, the journal’s joint editors, Martin Bobak and Jim Dunn, add: “This paper clearly shows that ‘scientific advice’ is not necessarily independent and that it is influenced by often undisclosed interests. From an editor’s point of view, this is disturbing, because there are limits as to how far journals can go in establishing authors’ conflicts of interest.”

###

[Academics and competing interests in H1N1 influenza media reporting Online First doi 10.1136/jech-2013-203128]

U.S. baby’s HIV infection cured through very early treatment

Sun, 3 Mar 2013 21:29 GMT

Reuters

* Mississippi girl’s case is the first account of an HIV cure in an infant

* Doctors started treatment within 30 hours of the child’s birth

By Julie Steenhuysen

CHICAGO, March 3 (Reuters) – A baby girl in Mississippi who was born with HIV has been cured after very early treatment with standard drug therapy, U.S. researchers reported on Sunday, in a potentially ground-breaking case that could offer insights on how to eradicate HIV infection in its youngest victims.

The child’s story is the first account of an infant achieving a so-called functional cure, a rare event in which a person achieves remission without the need for drugs and standard blood tests show no signs that the virus is making copies of itself.

More testing needs to be done to see if the treatment would have the same effect on other children, but the results could change the way high-risk babies are treated and possibly lead to a cure for children with HIV, the virus that causes AIDS.

“This is a proof of concept that HIV can be potentially curable in infants,” said Dr. Deborah Persaud, a virologist at Johns Hopkins University in Baltimore, who presented the findings at the Conference on Retroviruses and Opportunistic Infections in Atlanta.

The child’s story is different from the now famous case of Timothy Ray Brown, the so-called “Berlin patient,” whose HIV infection was completely eradicated through an elaborate treatment for leukemia in 2007 that involved the destruction of his immune system and a stem cell transplant from a donor with a rare genetic mutation that resists HIV infection.

Instead of Brown’s costly treatment, the Mississippi baby’s case involved the use of a cocktail of widely available drugs already used to treat HIV infection in infants.

When the baby girl was born in a rural hospital, her mother had just tested positive for HIV infection. Because her mother had not received any prenatal HIV treatment, doctors knew the child was born at high risk of being infected. So they transferred the baby to the University of Mississippi Medical Center in Jackson, where she came under the care of Dr. Hannah Gay, a pediatric HIV specialist.

Because of her high infection risk, Dr. Gay put the infant on a cocktail of three standard HIV-fighting drugs when she was just 30 hours old, even before lab tests came back confirming her infection. In more typical pregnancies when an HIV-infected mother has been given drugs to reduce the risk of transmission to her child, the baby would only have been given a single drug to reduce her infection risk.

Researchers believe this early use of antiviral treatment likely resulted in the infant’s cure by keeping the virus from forming hard-to-treat pools of cells known as viral reservoirs, which lie dormant and out of the reach of standard medications. These reservoirs rekindle HIV infection in patients who stop therapy, and they are the reason most HIV-infected individuals need lifelong treatment to keep the infection at bay.

10-MONTH GAP

After starting on treatment, the baby’s immune system responded and tests showed levels of the virus were diminishing until it was undetectable 29 days after birth. The baby received regular treatment for 18 months, but then stopped coming to appointments for a period of about 10 months, when her mother said she was not given any treatment. The doctors did not say why the mother stopped coming.

When the child came back under the care of Dr. Gay, she ordered standard blood tests to see how the child was faring before resuming antiviral therapy.

What she found was surprising. The first blood test did not turn up any detectible levels of HIV. Neither did the second. And tests for HIV-specific antibodies – the standard clinical indicator of HIV infection – also remained negative.

“At that point, I knew I was dealing with a very unusual case,” Dr. Gay said.

Baffled, Dr. Gay turned to her friend and longtime colleague, Dr. Katherine Luzuriaga of the University of Massachusetts, and she and Persaud did a series of sophisticated lab tests on the child’s blood.

The first looked for silent reservoirs of the virus where it remains dormant but can replicate if activated. That is detected in a type of immune cell known as a CD4 T-cell. After culturing the child’s cells, they found no sign of the virus.

Then, the team looked for HIV DNA, which indicates that the virus has integrated itself into the genetic material of the infected person. This test turned up such low levels that it was just above the limit of the test’s ability to detect it.

The third test looked for bits of genetic material known as viral RNA. They only found a single copy of viral RNA in one of the two tests they ran.

Because there is no detectible virus in the child’s blood, the team has advised that she not be given antiretroviral therapy (ART), whose goal is to block the virus from replicating in the blood. Instead, she will be monitored closely.

Dr. Rowena Johnston, vice president and director of research for the Foundation for AIDS Research, which helped fund the study, said the fact that the cure was achieved by antiretroviral therapy alone makes it “imperative that we learn more about a newborn’s immune system, how it differs from an adult’s and what factors made it possible for the child to be cured.”

Because the child’s treatment was stopped, the doctors were able to identify that this child had been cured, raising questions about whether other children who received early treatment and have undetectable viral loads may also be cured without knowing it.

But the doctors warned parents not to be tempted to take their children off treatment to see if the virus comes back. Normally, when patients stop taking their medications, the virus comes roaring back, and treatment interruptions increase the risk that the virus will develop drug resistance.

“We don’t want that,” Dr. Gay said. “Patients who are on successful therapy need to stay on their successful therapy until we figure out a whole lot more about what was going on with this child and what we can do for others in the future.”

The researchers are trying to find biomarkers that would offer a rationale to consider stopping therapy within the context of a clinical trial. If they can learn what caused the child to clear her virus, they hope to replicate that in other babies, and eventually learn to routinely prevent infections.  (Reporting by Julie Steenhuysen; Editing by Jilian Mincer and Sandra Maler)

http://www.trust.org/alertnet/news/us-babys-hiv-infection-cured-through-very-early-treatment/

‘Dung of the devil’ plant roots point to new swine flu drugs: Showed greater potency against influenza A (H1N1) than a prescription antiviral drugs

2009 study posted for filing

Contact: Michael Woods m_woods@acs.org 202-872-6293 American Chemical Society

Scientists in China have discovered that roots of a plant used a century ago during the great Spanish influenza pandemic contains substances with powerful effects in laboratory experiments in killing the H1N1 swine flu virus that now threatens the world. The plant has a pleasant onion-like taste when cooked, but when raw it has sap so foul-smelling that some call it the “Dung of the Devil” plant. Their report is scheduled for the Sept. 25 issue of ACS’ Journal of Natural Products, a monthly publication.

In the study, Fang-Rong Chang and Yang-Chang Wu and colleagues note that the plant, Ferula assa-foetida, grows mainly in Iran, Afghanistan and mainland China. People used it as a possible remedy during the1918 Spanish flu pandemic that killed between 20 to 100 million people. Until now, however, nobody had determined whether the plant does produce natural antiviral compounds.

Chang and Wu identified a group of chemical compounds in extracts of the plant that showed greater potency against influenza A (H1N1) than a prescription antiviral drug available for the flu. “Overall, the present study has determined that sesquiterpene coumarins from F. assa-foetida may serve as promising lead components for new drug development against influenza A (H1N1) viral infection,” the authors write.

###

 

ARTICLE #1 FOR IMMEDIATE RELEASE “Influenza A (H1N1) Antiviral and Cytotoxic Agents from Ferula assa-foetida”

DOWNLOAD FULL TEXT ARTICLE: http://pubs.acs.org/stoken/presspac/presspac/full/10.1021/np900158f

CONTACT: Fang-Rong Chang, Ph.D. Yang-Chang Wu, Ph.D. Kaohsiung Medical University. Kaohsiung 807, Taiwan, Republic of China Phone: 886-7-312-1101, ext. 2197 Fax: 886-7-311-4773 E-mail: yachwu@kmu.edu.tw or aaronfrc@kmu.edu.tw

Tamiflu survives sewage treatment ( oseltamivir )

Contact: Jerker Fick jerker.fick@chem.umu.se 46-480-446-225 Public Library of Science

Swedish researchers have discovered that oseltamivir (Tamiflu); an antiviral drug used to prevent and mitigate influenza infections is not removed or degraded during normal sewage treatment. Consequently, in countries where Tamiflu is used at a high frequency, there is a risk that its concentration in natural waters can reach levels where influenza viruses in nature will develop resistance to it. Widespread resistance of viruses in nature to Tamiflu increases the risk that influenza viruses infecting humans will become resistant to one of the few medicines currently available for treating influenza.

”Antiviral medicines such as Tamiflu must be used with care and only when the medical situation justifies it,” advises Björn Olsen, Professor of Infectious Diseases with the Uppsala University and the University of Kalmar. “Otherwise there is a risk that they will be ineffective when most needed, such as during the next influenza pandemic.”

The Swedish research group demonstrated that oseltamivir, the active substance in Tamiflu, passes virtually unchanged through sewage treatment.

“That this substance is so difficult to break down means that it goes right through sewage treatment and out into surrounding waters,” says Jerker Fick, Doctor in Chemistry at Umeå University and the leader of this study.

The Swedish research group also revealed that the level of oseltamivir discharged through sewage outlets in certain countries may be so high that influenza viruses in nature can potentially develop resistance to the drug.

“Use of Tamiflu is low in most countries, but there are some exceptions such as Japan, where a third of all influenza patients are treated with Tamiflu,” explains Jerker Fick.

Influenza viruses are common among waterfowl, especially dabbling ducks such as mallards. These ducks often forage for food in water near sewage outlets. Here they can potentially encounter oseltamivir in concentrations high enough to develop resistance in the viruses they carry.

“The biggest threat is that resistance will become common among low pathogenic influenza viruses carried by wild ducks.” adds Björn Olsen.  These viruses could then recombinate with viruses that make humans sick to create new viruses that are resistant to the antiviral drugs currently available.

The Swedish researchers advise that this problem must be taken seriously so that humanity’s future health will not be endangered by too frequent and unnecessary prescription of the drug today.

###

Disclaimer

This press release refers to an upcoming article in PLoS ONE. The release has been provided by the article authors and/or their institutions.  Any opinions expressed in this are the personal views of the contributors, and do not necessarily represent the views or policies of PLoS. PLoS expressly disclaims any and all warranties and liability in connection with the information found in the release and article and your use of such information.

Their study was published in the high-ranked journal PLoS ONE. The entire article is available free online, and can be read at the following address: http://www.plosone.org/doi/pone.0000986

Citation: Fick J, Lindberg RH, Tysklind M, Haemig PD, Waldenstro¨m J, et al (2007) Antiviral Oseltamivir Is not Removed or Degraded in Normal Sewage Water Treatment: Implications for Development of Resistance by Influenza A Virus. PLoS ONE 2(10): e986. doi:10.1371/journal.pone.0000986

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT (URL live from October 2): http://www.plosone.org/doi/pone.0000986

* Requested Repost