HPV vaccine access easier for US preteens after panel ruling

It’s now easier for preteens to get the cervical cancer vaccine.

A government panel on Wednesday recommended that preteens get two shots instead of three and space them further apart. The Centers for Disease Control and Prevention immediately made the change.

“It will be simpler now for parents to get their kids the HPV vaccine series, and protect their kids from HPV cancers,” said the CDC’s Dr Nancy Messonnier.

The vaccine protects against human papillomavirus – or HPV – which can cause cervical cancer, certain other cancers and genital warts. It is commonly spread through sex and, in most cases, the virus doesn’t cause any problems. But some infections gradually lead to cancer.

Health officials want kids to get HPV vaccinations at age 11 or 12, well before most first have sex and before they could be infected.

But less than one-third of 13-year-old US boys and girls have gotten three doses. Busy parents have struggled with the old schedule, which called for three trips to the doctor within six months.

“I know people who say ‘I can’t do that. Why even start?”’ said Cynthia Pellegrini, a March of Dimes official who sits on the panel.

Recent studies have shown two doses of the current HPV vaccine – Gardasil 9 – work just as well in kids ages nine to 14. The Food and Drug Administration two weeks ago said it could be given in two doses.

What’s more, two doses apparently work better when spaced six to 12 months apart. That means they could be given at annual checkups.

The Advisory Committee on Immunization Practices made the recommendation at a meeting in Atlanta.

The panel stuck with three doses for anyone who doesn’t get their first shot until they turn 15. That’s because they didn’t have enough data on how well two doses worked in older kids.

The vaccine was first recommended in 2006 for girls, and then for boys in 2011 – partly to reduce the spread of HPV to girls.

Vaccination rates have risen very slowly, and health officials have lamented the underuse of a potent cancer prevention tool.

Too many doctors have been timid about promoting the shots, experts say. That’s at least partly because some parents have worried the vaccination seems like they are greenlighting their kids to have sex.

But the onerous schedule didn’t help. “I think it was the icing on the cake” for parents already hesitant about HPV shots, said Dr William Schaffner, a vaccines expert at Vanderbilt University.

Until recently, there were three HPV vaccines on the market. Now there’s only one – Merck & Co’s Gardasil 9. This month, the company stopped selling an older version. GlaxoSmithKline phased out its vaccine, Cervarix, in the US because of poor sales.

HPV vaccine access easier for US preteens after panel ruling

"Moonshot" cancer panel calls for US to create national research database

Top US cancer scientists have urged the Obama administration to create a national cancer database for clinicians and patients as part of a slew of recommendations presented on Wednesday by the White House-supported cancer “moonshot” panel.

Vice-president Joe Biden assembled the scientists as part of the administration’s effort to make the US the country that cures cancer “once and for all”.

The Cancer Moonshot Blue Ribbon Panel report said the recommendations, if implemented, “will transform our understanding of cancer and result in new opportunities to more effectively prevent and treat the disease”.

The ten recommendations include existing programs that need more funding – such as research to update guidelines for patient symptom control – and brand new initiatives including a human tumor database to monitor and analyze multi-dimensional cell behavior.

The panel also called for the creation of a network of databases for patients to profile their cancers and pre-register for clinical trials; the organization of a cancer immunotherapy clinical trial network; and the study and development of therapies that prevent or overcome drug resistance.

The panel also recommended initiatives to improve the understanding of a protein tied to pediatric cancers; increase monitoring and management of symptom care and treatment; support development of new testing and treatment technologies; and improve prevention and early detection.

But the funding necessary to fulfill these recommendations has not been approved by Congress despite lobbying by the Obama administration, which said it hoped to spend $ 1bn on the program.

“Congress should seize this historic opportunity – when researchers are on the brink of so many new and potentially life-saving developments in diagnostic tests and treatments – to boost funding for the NIH [National Institutes of Health] and NCI [National Cancer Institute],” said Gary Reedy, CEO of the American Cancer Society (ACS) and the not-for-profit organization’s action network, ACS CAN, in a statement.

The ACS said in January that it expects 1.6m new cancer cases to be diagnosed in 2016, the equivalent of about 4,600 new diagnoses each day.

Barack Obama announced that he had tasked Biden with leading the moonshot program in his final State of the Union address in January. The program aims to accomplish “a decade’s worth of cancer research progress in five years”.

It is a personal effort for Biden, whose son, Joseph “Beau” Biden III, died from brain cancer in 2015 at the age of 46. Last year, Biden helped secure a $ 264m increase in federal funding to the National Cancer Institute in the spending bill.

The panel report is a major step in that direction, and will be presented to the National Cancer Advisory Board on Wednesday, where it is expected to be formally accepted.

To determine the recommendations, the country’s top cancer scientists were divided into seven working groups to focus on elements like immunology and clinical trials. More than 1,600 ideas and comments were also submitted by the public.

Along with the recommendations, the panel also listed policy issues that needed to be addressed so that the recommendations could be efficiently implemented, including laws around patient privacy, the clinical trial system and insurance coverage.

Biden and Obama have acknowledged that it is unlikely cancer will be cured in the next five years, but they have said the moonshot program could create unprecedented strides in the fight against the disease.

“The key for us now is to put a lot more money into research,” Obama said in January. “If we do, I think we’re going to see some really big breakthroughs soon.”

"Moonshot" cancer panel calls for US to create national research database

No Retraction For You! Evaluation Panel Exonerates Medical Journal In Statin Kerfuffle

An independent assessment panel has rejected a demand by a prominent researcher that TheBMJ retract two controversial articles or blog posts. The report largely exonerates the journal’s editors from any wrongdoing.

As previously reported, Rory Collins, a prominent researcher and head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, had demanded that TheBMJ retract two content articles that had been highly essential of statins. Although TheBMJ issued a correction for both papers for inaccurately citing an earlier publication and therefore overstating the incidence of adverse results of statins, this response did not satisfy Collins. He repeatedly demanded that the journal issue a complete retraction of the articles or blog posts, prompting TheBMJ’s editor-in-chief, Fiona Godlee, to convene an outdoors panel of experts to overview the issue.

The report of the independent statins evaluation panel exonerates TheBMJ from wrongdoing and explained the controversial articles ought to not be retracted:

The panel have been unanimous in their choice that the two papers do not meet any of the criteria for retraction. The error did not compromise the principal arguments being manufactured in both of the papers. These arguments involve interpretations of accessible proof and have been deemed to be inside of the variety of sensible opinion amid people who are debating the proper use of statins.

In fact, the panel was critical of Collins for refusing to submit a published response to the articles or blog posts:

The panel mentioned with concern that in spite of the Editor’s repeated requests that Rory Collins ought to place his criticisms in writing as a quick response, a letter to the editor or as a stand-alone write-up, all his submissions were obviously marked ‘Not for Publication’. The panel considered this unlikely to encourage open scientific dialogue in the tradition of the BMJ.

The report did uncover some minor deficiencies in the editorial procedure at TheBMJ and stated that the delay  from publication of the content articles in October 2013 to the correction in Might 2014 was as well long. The panel explained that the journal “should put into action a significant event audit… to try out and recognize what would want to have been in location to guarantee that the correction was produced in a much more timely vogue.”

They also stated that press releases should be used “cautiously” for viewpoint pieces about controversial subjects.

The panel did not express an view about the hazards and positive aspects of statins:

It is crucial to note that the panel has not been asked to pass judgment on the dangers and advantages of statins per se, nor on the suitable use of statin medicine in lower danger people. Instead the panel has been asked to decide no matter whether there are adequate grounds to need retraction of a single or each of the content articles from the scientific literature. The panel has been at pains not to take sides and not to assistance a single view at the expense of one more.

Panel member Harlan Krumholz offered the following comment:

I had the privilege of serving with a exceptional set of authorities who took the charge seriously and invested a great number of hours investigating the issue and deliberating above the recommendation. The panel did not weigh in on the concern of the chance of statins, but judged the merits of the get in touch with for retraction. In the finish there was minor doubt that the view pieces in the BMJ did not meet criteria for retraction and the correction that had been created was adequate.

No Retraction For You! Evaluation Panel Exonerates Medical Journal In Statin Kerfuffle

AstraZeneca"s contact to velocity approval of cancer drug rejected by US panel

AstraZeneca, Britain’s second-largest drugmaker fought off a £69bn takeover approach from US rival Pfizer final month. Photograph: Phil Noble/Reuters

AstraZeneca has suffered a setback right after a panel of US overall health authorities rejected its request for accelerated approval of a new ovarian cancer drug.

The shock determination by the US FDA’s Oncologic Medication Advisory Committee comes at a delicate time, with Britain’s second-biggest drugsmaker working difficult to supply on its drug pipeline right after fighting off a £69bn takeover method from bigger US rival Pfizer last month. Any setbacks on new medicines could stir discontent amid AstraZeneca shareholders, some of whom needed the board to engage further with Pfizer.

The FDA panel asked the AstraZeneca to submit more clinical information on olaparib, a upkeep treatment for relapsed ovarian cancer which is in mid-stage clinical trials.

The information is due at the end of 2015, but AstraZeneca had hoped to get the green light for the remedy from the FDA in October. Chief medical officer Briggs Morrison said the organization was disappointed by the determination.

Even though the setback must have minor affect on AstraZeneca’s future revenues and profits, investors and analysts are viewing closely for any slip-up in its R&ampD efforts.

New medicines are important to its ambitious forecast of a 75% leap in revenues from $ 26bn to more than $ 45bn by 2023, a key plank of the defence technique outlined by chief executive Pascal Soriot. At the heart of it are new cancer immunotherapy remedies, for which the business acquired largely good feedback at a big US oncology conference at the commence of the month.

Bernstein analyst Tim Anderson explained: “The rejection comes at a essential time simply because failed R&ampD efforts might make AstraZeneca shareholders more inclined to push AstraZeneca into Pfizer’s arms. Is the olaparib ruling a main setback for AstraZeneca that will materially adjust how traders consider about AstraZeneca? No, but every single bit of slippage at the firm probably does tilt the balance somewhat more in favour of a future Pfizer-AstraZeneca tie-up.”

He reckons the odds are less than 50% that either AstraZeneca asks Pfizer back to the negotiating table in under two months, or the New York drugsmaker returns with a greater supply in November, but “obviously the predicament is fluid”. AstraZeneca is reportedly thinking about promoting off the rights to future revenues from present medicines or partnering on assets to make itself significantly less appealing to Pfizer.

Meanwhile, analysts at Jefferies earlier this month put an 80% probability on AstraZeneca inviting Pfizer back right after a mandatory cooling-off period ends in late August.

AstraZeneca"s contact to velocity approval of cancer drug rejected by US panel

Jeremy Hunt need to investigate statins tips panel, says Labour

On Wednesday Prof Mark Baker, a senior Nice official, described the considerations as “completely unjustified” . None of the panel members stood to acquire financially from the guidance, he additional.

All of the back links, such as payments for sitting on advisory boards for drug companies and acquiring funding for investigation, have been formally declared to Nice and published on-line.

Nonetheless, Sarah Wollaston, a Conservative member of the Commons wellness decide on committee and a former GP, said: “This ought to lead to an examination by Good. It is a concern as this panel’s choice has this kind of widespread implications for prescribing and expense to the NHS.”

“I feel there are various levels. Sometimes the conflict of interests can be extremely small. It is about the degree of the conflict.

“I feel it is very critical that the public can clearly see what degree of conflict they have and can be confident they have the proper stability of Good specialists.

“Doctors require to have a register much like MPs do, of outdoors interests, so men and women can swiftly and simply see what their interests are. ”

She continued: “A broadly trusted independent physique demands to be in a position to examine the information as well.

“The concern is that we will end up medicating healthier people.”

Andrew Gwynne, the shadow wellness minister, extra: “Patients want to come to feel the suggestions they get can be trusted – but the lack of transparency in this method will be concerned them additional.

“Neither large firms nor individuals should stand to personally profit from choices about our care. Jeremy Hunt must launch an investigation without delay.”

Great will publish its last recommendations subsequent month, following a public consultation.

In February it announced its ideas to reduce the “risk threshold” for statins in half — meaning that the huge vast majority of guys aged over 50 and most females in excess of the age of 60 are likely to be advised to consider the medication to guard against strokes and heart disease.

Nice says the advice will prevent a lot of men and women from turning into unwell and dying prematurely.

Even so, in a letter to Mr Hunt and Great, the group of 9 doctors, which includes Sir Richard Thompson, the president of the Royal College of Doctors, cited analysis, independent of the drug industry, showing that statins have been connected with a 48 per cent boost in the chance of diabetes in middle-aged girls.

Other likely side results could contain depression, fatigue and erectile dysfunction, they warned.

Jeremy Hunt need to investigate statins tips panel, says Labour

BMJ Names Panel Members To Assessment Disputed Statin Posts

The BMJ has launched the names of an outdoors professional panel who will decide the fate of two posts that are the subject of a heated dispute.

As previously reported, final week the BMJ published a correction to two papers published last year, explaining that the two papers had  inaccurately overstated the incidence of the adverse results of statins. However, a fierce critic of the papers, the head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, Rory Collins, still insisted upon a full retraction. In an editorial published in BMJ, the journal’s editor-in-chief, Fiona Godlee, wrote that she was  uncertain “whether the error is sufficient for retraction, offered that the incorrect statements had been in every case secondary to the article’s major focus.” As a end result the BMJ has convened an outdoors panel of authorities “with no canine in this battle.”

Iona Heath, former chair of the Royal School of General Practitioners and of The BMJ’s ethics committee, will be the chair of the panel. There are 6 further members:

• Stephen Evans, professor of pharamcoepidemiology at the London College of Hygeine and Tropical Medication


• Curt Furberg, professor emeritus of public wellness sciences at Wake Forest University College of Medication, North Carolina


• Julia Hippisley-Cox, professor of epidemiology and common practice at the University of Nottingham


• Harlan Krumholz, Harold H. Hines Jr. professor of medication (cardiology) and professor of investigative medication and of public well being (health policy) at Yale School of Medication


• Cynthia Mulrow, senior deputy editor at Annals of Internal Medication and adjunct professor of medicine at Texas University of Health Science Center


•  Paul Wilks, vice president of innovation, Patients Like Me

In addition to determining whether or not the report must be retracted, the panel will also “review and comment on the process by which the articles or blog posts were published” and “on how criticisms and complaints against the articles or blog posts had been raised, and how the journal responded.” The report will be delivered to the BMJ by July 31, 2014 and will be published on the journal’s site.

BMJ Names Panel Members To Assessment Disputed Statin Posts

FDA Advisory Panel Suggests Towards Approval Of Novartis Heart Failure Drug

The FDA’s Cardiovascular and Renal Medicines Advisory Committee voted unanimously  (eleven-) towards approval of the biologics license application (BLA) for serelaxin (proposed trade name Reasanz). The novel drug from Novartis was meant to be employed in patients with acute heart failure. The when extremely-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval in Europe earlier this 12 months.

FDA reviewers and committee members expressed no substantial worries over the security of the drug.But they have been troubled by the seemingly impenetrable benefits of the pivotal Unwind-AHF trial. Throughout the day the Novartis speakers, including heart failure experts Milton Packer and Loosen up-AHF investigator Barry Greenberg, attempted to make clear and justify the complex trial, which only met one of its two co-primary endpoints.

But panel members remained skeptical. They located that flaws in trial design and style created it extremely hard to accurately assess the effect of the drug. They did not completely reject the surprising obtaining of a mortality reduction at 180 days in Chill out-AHF, but simply because it was not a prespecified endpoint they mentioned it necessary to be tested in a followup research.

Right after the vote most of the panelists advised the business to continue development of the drug given that it may possibly in the end help handle an important unmet healthcare need to have.

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FDA Advisory Panel Suggests Towards Approval Of Novartis Heart Failure Drug

FDA Advisory Panel Recommends Towards Approval Of New Medicines Firm Heart Drug

The FDA’s Cardiovascular and Renal Medicines Advisory Committee these days advised against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Firm. In a 7-2 vote the panel 1st rejected an indication  for the reduction of thrombotic cardiovascular occasions such as stent thrombosis in patients undergoing PCI.

The panel also voted unanimously to reject a second indication, for the maintenance of antiplatelet therapy in patients with acute coronary syndromes or sufferers with stents who have discontinued antiplatelet therapy due to the fact they are awaiting surgical treatment and are at higher threat for thrombotic occasions. FDA reviewers, who had delivered mixed opinions for the first indication, had suggested a total response letter for the 2nd indication, because the company had failed to complete a trial showing clinical advantage for the indication.

During the day panel members wrestled with issues with the pivotal CHAMPION PHOENIX trial, which attempted to treatment the deficiencies of two earlier damaging trials. Even though most panel members agreed that PHOENIX showed a advantage compared to the clopidogrel handle group, the advantage appeared small and the committee was concerned that cangrelor may possibly have acquired an unfair advantage simply because in the handle group clopidogrel was not used ideally, given that several  did not receive preloaded large-dose clopidogrel. An additional concern was that most of the difference amongst the groups was due to a reduction in periprocedural MIs. Panelists after again raised the query of the clinical relevance of this obtaining. Finally, the higher threat of bleeding with clopidogrel appeared to largely offset the observed advantages.

Panel member Milton Packer, who voted against approval, explained that he needed to vote yes and that he considered an antiplatelet agent with fast on/off properties may properly demonstrate beneficial. But, he said, the sponsor had not demonstrated that cangrelor was superior to full dose clopidogrel.

FDA Advisory Panel Recommends Towards Approval Of New Medicines Firm Heart Drug

FDA Panel After Once more Rejects New Indication For J&J Drug

(Photograph credit: Wikipedia)

The FDA’s Cardiovascular and Renal Drugs Advisory Committee once once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson &amp Johnson’s Xarelto (rivaroxaban). The virtually unanimous vote (10-, with one abstention) was in line with a hugely adverse overview from FDA workers members.

Although originally the topic of higher praise when it initial came out, the pivotal ATLAS ACS two-TIMI 51 trial has been bedeviled by criticism because the FDA drew consideration to the unusually massive sum of missing trial information. Previous discussions of the trial at the FDA brought the word “missingness” into widespread utilization in the health-related local community. Although J&ampJ made efforts to supply some of the missing data this time around, in the end the panel members agreed with the most latest assessment from the FDA reviewers that the huge quantity of still-missing data made it unattainable to reach firm conclusions about the relative security and efficacy of the drug in the setting of ACS.

Panel member Linda Fried, from the University of Pittsburgh, gave voice to a view adopted by many of the committee members. ATLAS, she mentioned, was most likely “an all round optimistic study” but, since of the big sum of missing information and the absence of a confirmatory research, was “not robust enough” to support the ACS indication. Speaking on behalf of the sponsor, cardiologists C. Michael Gibson and Marvin Konstam attempted to persuade the panel to accept their numerous constructive analyses of the trial. But panel members, such as outspoken critics like Steve Nissen and Sanjay Kaul, left small doubt all through the day’s meeting that they have been unlikely to vote in favor of the new indication.

“We enjoy the thoroughness of the committee’s evaluation and proceed to feel rivaroxaban, in addition to the recent normal of care, might aid provide sufferers with ACS further safety against lifestyle-threatening cardiovascular occasions this kind of as death, heart assault and stroke. We will operate with the FDA to tackle questions raised nowadays,” mentioned J&ampJ’s Paul Burton, in a statement.

FDA Panel After Once more Rejects New Indication For J&J Drug

FDA Advisory Panel Votes In Favor Of Approval For Merck"s Vorapaxar

(Photograph credit: Wikipedia)

The FDA’s Cardiovascular and Renal Medicines Advisory Committee voted ten-1 in favor of approval for vorapaxar, Merck’s Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché may have been invented for this drug, which was the topic of tremendous early hopes followed by main disappointments and, finally, a subsequent revival.

The committee voted in favor of the drug for use as an adjunctive therapy for the reduction of atherothrombotic events in individuals with a background of myocardial infarction (MI). Panel chairperson Philip Sager explained that “this drug addresses a true unmet medical require and can make a real variation for sufferers.”

The University of Colorado’s Mori Krantz provided the a single unfavorable vote, however in his comments he indicated that he was not completely opposed to approval. He characterized his vote as a “formal dissent” and explained that he desired to get on the record his concerns about the large amount of individuals who would need to be taken care of with vorapaxar to stop a single occasion and his dread that the bleeding problems observed in the study may be amplified in the real world.

Sanjay Kaul stated that Merck ”convincingly demonstrated that the advantage exceeded the risk in the chosen patient cohort. Like all advancement programs, it has it’s fair share of warts, but there is an unmet need in this population where we have no safe and effective therapies accessible. Hopefully, if accredited it will be utilized in situations that optimize its advantage-risk profile.”

The panel spent much of the day wrestling with the complicated questions raised by the drug’s troubled history, in which a single massive trial, TRACER, was stopped early due to large charges of significant bleeding and the other trial, the TRA2P trial, was redesigned in midstream. But eventually the panel believed that TRA2P had been able to show that vorapaxar was successful in a post-MI population in which sufferers with a historical past of stroke had been excluded.

FDA Advisory Panel Votes In Favor Of Approval For Merck"s Vorapaxar

Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel

The third time could not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson &amp Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Medication Advisory Committee will get up the sNDA nevertheless yet again, but FDA assessment documents posted today suggest that the organization will once more face an uphill battle.

Originally, back in 2011, most observers considered the ACS indication would be a snap. The pivotal ATLAS ACS 2-TIMI 51 trial was extensively praised when it came out and the FDA promptly granted priority review for the indication. But  momentum, as I’ve reported before, ground to a halt when FDA reviewers raised queries about the ATLAS trial. The FDA advisory panel, highlighted by vocal criticisms from Steve Nissen and Sanjay Kaul, resulted in a vote against the ACS indication, foremost to the very first comprehensive response letter. The FDA issued a 2nd total response letter final March but J&ampJ restated its self confidence in the trial and its commitment to pursue the indication.

The earlier rejections were based mostly largely on the significant amounts of missing followup information from the trial. The FDA and J&ampJ thought that this difficulty might be circumvented by pursuing an indication for a shorter 90-day remedy duration, given that significantly of the missing information was for longer followup. But the brief phrase information do not seem very convincing and the FDA reviewers make clear in the new assessment paperwork that they now have grave considerations about this technique. (For readers interested in the particulars and minutiae of FDA-sponsor interactions and negotiations, the briefing paperwork include a series of letters from the FDA that supply a fascinating retrospective view of this complicated process.)

There was much more negative news for J&ampJ in the announcement of the panel participants. Former critics Steve Nissen and Sanjay Kaul are on the roster again and will be joined by mentioned pharma critic Sidney Wolfe. In addition, and maybe even more unsafe for J&ampJ, is one of the scheduled FDA presenters, clinical reviewer Thomas Marciniak. He has turn into well recognized for his scathing critiques of rosiglitazone and the angiotensin receptor blockers in addition to rivaroxaban.

Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel