How brilliant is Brilinta?

AstraZeneca US drug trial queried

AstraZeneca's chief executive Pascal Soriot says he is very confident in the findings of the clinical trial of heart drug Brilinta. Photograph: Lynne Cameron/PA

AstraZeneca is being investigated by US authorities over a clinical trial that was used to win marketing approval for its heart drug Brilinta, casting fresh doubts over the medicine.

Brilinta sales have been a disappointment since its launch two years ago, although AstraZeneca has recently stepped up marketing efforts and hopes that further clinical tests will underscore its value in preventing heart attacks.

The British drugmaker said on Thursday it received a civil investigative demand from the US department of justice, seeking documents and information regarding the Plato (platelet inhibition and patient outcomes) study.

AstraZeneca plans to co-operate with the DOJ and its chief executive, Pascal Soriot, said he was "very confident" in the findings of the trial. "It was guided by a strong academic group who oversaw the trial and its conduct," he told reporters after announcing third-quarter results.

AstraZeneca did not disclose the exact nature of the investigation and DOJ spokesman Peter Carr in Washington said he had no immediate comment on the case.

The results of the 18,000-patient trial were first reported in 2009 and went on to form the basis of successful new drug applications in the US, Europe and other markets. Brilinta was launched in 2011.

Aspects of the study, which relied heavily on patients recruited in eastern Europe, have been criticised by medical experts. Poland and Hungary together accounted for 21% of the subjects studied – more than double the US and Canada combined.

James DiNicolantonio of Ithaca New York and Ales Tomek of Charles University in Prague raised several questions about the conduct of the study in a recent paper in the International Journal of Cardiology.

In particular, their analysis found that patients in the Plato trial who were monitored by AstraZeneca were reported as having more beneficial effects from taking Brilinta than those monitored by an independent clinical research organisation.

Those conclusions, however, have been strongly disputed by Lars Wallentin of Uppsala clinical research center in Sweden, the principal investigator on Plato.Brilinta is a key product for AstraZeneca but its progress to date has been slow, with sales in the third quarter edging up to just $75m (£47m) from $65m in the three months to end-June – a long way from the multibillion-dollar sales potential that analysts once predicted.

Among the challenges it faces is the fact that US doctors tend to use high-dose aspirin for cardiovascular patients, and clinical trials suggest AstraZeneca's new drug does not work as well in this setting.

AstraZeneca hopes that a new clinical study called Pegasus will put to rest any uncertainties about the effectiveness of Brilinta and also increase uptake of the medicine. Results are expected in 2014.

In addition to the DOJ inquiry into Brilinta, AstraZeneca also disclosed it had received a subpoena from the US Attorney's Office in Boston, seeking documents and information related to the safety of its antipsychotic drug Seroquel.

The news came as AstraZeneca promoted Marc Dunoyer to chief financial officer, plugging a gap in the management team as it grapples with falling sales and profits.

Dunoyer, 61, who joined from rival GlaxoSmithKline in June, will replace well-respected finance chief Simon Lowth, whose departure to join BG Group had been announced.

Hit by generic competition to key drugs, sales and profits at AstraZeneca continued to slide in the third quarter, underscoring the challenge facing Soriot, who has been in the job for just over a year. Lowth has been viewed as a steady hand on AstraZeneca's finances, and the appointment of Dunoyer, who lacks recent direct CFO responsibility, may concern some investors. Soriot and Dunoyer have their work cut out to turn around AstraZeneca after years of failure to come up with new drugs to replace those reaching the end of their patent life.

Improving AstraZeneca's record in drug research is Soriot's top priority, but he told Reuters in June that turning around the company would take three to four years.

It will also require investment in the science behind new medicines and AstraZeneca said it expected to spend more, with 2013 spending increasing at the upper end of its prior guidance range of a low-to-mid single-digit percentage rise on 2012.

Mark Clark of Deutsche Bank said higher operating costs suggested there would be "minor" downgrades in earnings forecasts.

Sales in the quarter slid by 6% to $6.25bn, weighed down by the loss of patent protection on several drugs – including, in some markets, its top-selling cholesterol fighter Crestor.

"Core" operating profit was $2.03bn.

Growth in drug sales in China, where destocking and an anti-corruption drive disrupted business, slowed to 13% from 21% in the second quarter. But AstraZeneca fared a lot better than GlaxoSmithKline, the company at the centre of the scandal, whose China sales crashed 61% percent in the third quarter.

http://www.theguardian.com/business/2013/oct/31/astrazeneca-us-drug-trial?

AllTrials - The Harvard Way

Report Proposes Ways to Expand Access to Clinical Trial Data

Researchers from Harvard, together with members of a group created by the Multi-Regional Clinical Trials Center, released a report last week that proposed ways to expand access to clinical trial data.

The report--published online in The New England Journal of Medicine--outlined the possible benefits and risks, ethical and legal issues, and logistical questions associated with expanding access to participant-level data, which have, in the past, been considered confidential by the Food and Drug Administration, which regulates clinical trials of drugs conducted in the US.

Addressing concerns about sponsor-supported results, the authors stated that expanded access to clinical data could allow for a greater scientific innovation and a more accurate representation of a product’s safeness and effectiveness.

“Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data,” said Michelle M. Mello, a professor at Harvard School of Public Health and lead author of the report, in a press release.

While Mello emphasized the importance of providing independent scientists with access to clinical trial data, she also cautioned against the risk of revealing participants’ identities and providing too much information, which might strain trial sponsors.

“The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants’ privacy, avoiding ‘junk science,’ and minimizing burdens on trial sponsors?” Mello said in the release.

The report also discussed current initiatives to expand data access. For instance, the European Medicines Agency recently announced that it will start providing participant-level data that is submitted for regulatory purposes.

The authors recommended that new regulations targeted at expanding data sharing should be applied to trials of all approved prescription drugs, medical devices, and biologics in a way that preserves research participant privacy and treats sponsors and researchers “evenhandedly.”

Although the report does not come to a conclusion about how access to data should be expanded, it emphasizes that the expanded access to data is a question of how the transparency should be achieved, not whether or not it will.

http://www.thecrimson.com/article/2013/10/31/Expanding-Clinical-Trials/?

Herper grills Witty! Well, lightly toasts .....

http://www.forbes.com/sites/matthewherper/2013/10/29/can-this-man-make-you-believe-in-drug-companies/#!

Martha Rosenberg gets my vote, Marylyn!

Pharma 'Muckraker' Top Choice for New Journalism Project

By GUEST BLOGGER | Published: OCTOBER 25, 2013

Pharma Muckraker?

Reporter Glenn Greenwald,  who has been in the news recently for disseminating  the whistle-blower and former CIA employee Edward Snowden’s information on the US’s mass surveillance  program has left the Guardian where his initial articles appeared.

Along with filmmaker Laura Poitras (also covering the Snowden story) and Jeremy Scahill, Greenwald is joining up with Pierre Omidyar, one of the founders of Ebay, who has announced that he’s funding a journalism project with $250 million dollars in seed money.

It’s intriguing media news in a  world where the line between editorial and advertising is increasingly blurred, and publications are dying off like flies.

Omidyar  intends to publish  progressive, long-form, investigative stories written by the country’s best specialist writers on a variey of different subjects.

Whose on his dream team?  He published his wish list on Tuesday  on Opednews.com.

And who would he pick to cover the pharma industry? Martha Rosenberg, he says,  “who does great investigative reporting on food and drug safety and big Pharma and big Agra.”

Her work is certainly provocative and hardhiting, and sometimes loads of fun to read, but is it fair?

Writing for a variey of publications, here are just a few of her recent titles: 6 New Ways Big Pharma Is Scheming to Make Billions at the Expense of Your Health (http://www.alternet.org/personal-health/6-new-ways-big-pharma-scheming-make-billions-expense-your-health). Posted on: Apr 25, 2013, Source: AlterNet: With many of Big Pharma’s biggest hits going off patent, the industry is looking for new ways to deliver earnings.

Big Pharma Company Mocked Patients Who Got “Jawbone Death” from Drug: “Ma Toot Hurts So Bad”

(http://www.alternet.org/drugs/big-pharma-company-mocked-patients-who-got-jawbone-death-drug-ma-toot-hurts-so-bad). Posted on: Nov 21, 2012, Source: AlterNet.

How Kids Are Getting Hooked on Pills for Life

(http://www.alternet.org/personal-health/how-kids-are-getting-hooked-pills-life). Posted on: Oct 18, 2012, Source: AlterNet. Young children were once expected to outgrow their issues; now they’re diagnosed with lifelong psychiatric problems.

You get the idea. My personal point of view is that it’s easy to muckrake, but a lot harder to dig deep to reveal texture and complexity of a topic. But we will wait and see. There’s always room for other voices.

By Marylyn Donahue.

Reporter Glenn Greenwald,  who has been in the news recently for disseminating  the whistle-blower and former CIA employee Edward Snowden’s information on the US’s mass surveillance  program has left The Guardian where his initial articles appeared. Along with filmmaker Laura Poitras (also covering the Snowden story) and Jeremy Scahill, Greenwald is joining up with Pierre Omidyar, one of the founders of Ebay, who has announced that he’s funding a journalism project with $250 million dollars in seed money.

It’s intriguing media news in a world where the line between editorial and advertising is increasingly blurred, and publications are dying off like flies.

Omidyar  intends to publish  progressive, long-form, investigative stories written by the country’s best specialist writers on a variety of different subjects.

Whose on his dream team?  He published his wish list on Tuesday on Opednews.com.

And who would he pick to cover the pharma industry? Martha Rosenberg, he says,  “who does great investigative reporting on food and drug safety and Big Pharma and Big Agra.”

Her work is certainly provocative and hard hitting, and sometimes loads of fun to read, but is it fair?

Writing for a variety of publications, here are just a few of her recent titles:

6 New Ways Big Pharma Is Scheming to Make Billions at the Expense of Your Health

Big Pharma Company Mocked Patients Who Got “Jawbone Death” from Drug

How Kids Are Getting Hooked on Pills for Life

You get the idea. My personal point of view is that it’s easy to muckrake, but a lot harder to dig deep to reveal texture and complexity of a topic. But we will wait and see. There’s always room for other voices.

http://blog.pharmexec.com/2013/10/25/will-pharmas-muckraker-join-new-journalist-team/

AllTrials contd. Unpublished Trial Data Violates An Ethical Obligation To Study Participants

29% of large clinical trials remain unpublished five years after completion and, of those, 78% have no results publicly available, according to a paper published yesterday.

This means that an estimated 250,000 people have been exposed to the risks of trial participation without the societal benefits that accompany the dissemination of their results, worry the authors. Of course, the participants all volunteered for the trials and had informed consent and many were even paid so claiming they were 'exposed to the risks' is emotional verbage designed to guide the public into one conclusion: all trial results should be published.

Of course, reality is not so simple. The public is already barraged with an array of media claims about studies that are not even published (Oreos are as addictive as cocaine,anyone?) - adding numerous trials with null results doesn't help. And if the trials were not funded with taxpayer money - most drug trials are not - there is no reason failures of products that will never get to market need to be made available, unlike government-controlled science that should obviously be published because the public paid for it.

Yet they argue that non-publication "violates an ethical obligation that investigators have towards study participants" and call for additional safeguards "to ensure timely public dissemination of trial data" because, they argue, randomized clinical trials are not just designed to show a product works but are a critical means of advancing medical knowledge - an argument that is not part of any law or regulation. 

Regardless, the authors on BMJ say trials depend on the "willingness of people to expose themselves to risks" and that they do so because society will eventually benefit from the knowledge gained from the trial, not because they are paid or may get a benefit from an experiment treatment. Clearly, the problem is not unpublished trial data, it is instead terrible informed consent policies. 

But when trial data remain unpublished, the societal benefit that may have motivated someone to enroll in a study remains unrealized. Who are these altruistic people undergoing experimentation with untested drugs for the common good? Best of luck finding them. Few results of that kind get published historically because journals are uninterested in publishing the results of negative trials.

US law requires that trials involving human participants now be registered - and their results posted - on the largest clinical trial website ClinicalTrials.gov. But the authors believe that this legislation has been largely ignored, yes companies are just brazenly violating federal law, it os contended, and they set out to estimate the frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in theClinicalTrials.gov database.

They searched PubMed, Google Scholar, and Embase and identified 585 trials with at least 500 participants that were registered with ClinicalTrials.gov and completed prior to January 2009 - before the mandatory requirement that came into effect September of 2009. The average time between study completion and the final literature search (November 2012) was 60 months for unpublished trials. Registry entries for unpublished trials were then reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.

Of 585 registered trials, 171 (29%) remained unpublished. Of these, 133 (78%) had no results available in ClinicalTrials.gov. Non-publication was more common among trials that received industry funding (32%) than those that did not (18%). Fair enough, except picking trials 8 months before the requirement skews the results and they used P values of <0.05 as statistically significant, which is fine, but the 0.05 threshold is arbitrary - it just happens to be common in reviews because P values are determined by comparing the test statistic against tabulations of specific percentage points of statistical distributions. 

There are also other reasons trials were exempt, which the authors leave out of their discussion - the studies may be exempt, they may not be completed or the date for submission may not have passed.

Accountability is fine but drug discovery is expensive, time-consuming and prone to overwhelming levels of failure. Demonizing drug companies will leave the public with nothing but academia or government to create new products - as the National Health Service's $9 billion IT and America's Healthcare.gov fiascoes have shown, when government can't even make websites work, they certainly can't be relied on to advance medicine.

In the same issue, BMJ engages in scaremongering about swaddling infants and dismisses concern that overcaffeinated energy drinks might be a health concern for developing children. Their poll question for the week is "Can New York City continue to be a global leader in public health under a new mayor?" when the evidence has shown that health has declined under the current mayor. Use caution when reading advocacy masked as data.

Citation: Christopher W Jones, Lara Handler, Karen E Crowell, Lukas G Keil, Mark A Weaver, Timothy F Platts-Mills, 'Non-publication of large randomized clinical trials: cross sectional analysis', BMJ
29 October 2013
 347 doi: 10.1136/bmj.f6104

http://www.science20.com/news_articles/unpublished_trial_data_violates_ethical_obligation_study_participants-123413?

Cancer - Big Pharma want to drain you of cash before you die

Avastin, $5,000/month; Zaltrap, $11,000/month; Yervoy, $39,000/month; Provenge, $93,000/course of treatment; Erbitux, $8,400/month; Gleevec, $92,000/year; Tasigna, $115,000/year; Sprycel, $123,000/year.

(Photo: Illustrations by Remie Geoffroi)

http://nymag.com/news/features/cancer-drugs-2013-10/#!

Tested?

The Big Business of Big Pharma

"via addiction-treatment.com" http://www.addiction-treatment.com/

Study questions FDA's shorter drug approval times

WASHINGTON (Reuters) - New drugs that receive expedited review by the Food and Drug Administration are being tested on fewer patients, leaving many safety questions unanswered even after they are approved, a study released on Monday in the Journal of the American Medical Association found.

Study authors Thomas Moore of the Institute for Safe Medication Practices and Dr Curt Furberg, a professor at Wake Forest School of Medicine, examined the development times, clinical testing and risks associated with 20 new drugs approved in 2008. Eight were given expedited review and 12 standard review.

It found that expedited drugs underwent a median of 5.1 years of clinical testing before being approved, compared with 7.5 years for those that underwent a standard review. But in many cases safety monitoring trials that were supposed to be conducted after the products were approved were either not conducted, not completed, or not submitted to the FDA.

"The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrower patient population with extensive additional testing conducted after approval," the authors said.

At the urging of patient groups, Congress and the drug industry, the FDA over the past decade has introduced multiple mechanisms for speeding new products to the market. While patient groups and drug companies applaud these measures, saying they get much-needed medication into the hands of patients more quickly, critics say the agency is approving products before they have been fully vetted.

Of the drugs studied by Moore and Furberg in 2008, the FDA required 85 follow-up trials to monitor for safety. By 2013, only 40 percent of those studies had been completed.

The FDA said in a statement that it will review the article in more detail but that on the surface "it shows that the expedited development programs are working as intended by getting promising new drugs to patients more quickly."

RELAXED EVIDENCE

The FDA has traditionally required two controlled clinical trials to prove that a drug is safe and effective. Over time the agency has relaxed the evidence it is willing to accept for certain products.

In some cases the FDA will accept data from a single trial and success may be judged on the basis of a surrogate measure - such as tumor shrinkage - that may or may not translate into a concrete measure such as increased survival.

"In situations of serious and life-threatening diseases with unmet medical need, patients and physicians who treat them have told us repeatedly that they are willing to accept greater uncertainty about risk in order to have access to the hope of improved treatment today," the FDA said in its statement.

The FDA is discussing additional measures to speed the drug development process, including the use of "enriched" trials that would select patients based on certain demographic or genetic characteristics in order to increase the chance of a trial's success.

The idea is to direct treatment to patients for whom it will be most effective or who are most likely to respond.

But in a commentary published alongside the study, Daniel Carpenter, a professor of government at Harvard University, said the FDA has put few measures in place to ensure that drugs that are approved based on limited populations are only marketed to those limited groups.

"The current system of accelerating drug approval in the United States can be described as a growing hodgepodge of exceptions to the rule of rigorous premarket review," he said.

The FDA said it has a "robust program for postmarketing surveillance and ensuring the completion of required post-approval trials."

"We believe that we have set the bar for the balance between pre-approval testing and early availability of promising new drugs to treat serious and life-threatening diseases in the right place."

(Reporting by Toni Clarke in Washington; editing by Matthew Lewis)

http://my.chicagotribune.com/#section/-1/article/p2p-77962809/

FDA introduces e-learning program about untruthful, misleading drug ads

The FDA's Office of Prescription Drug Promotion announced Monday the launch, with MedScape, of the e-learning course, which offers continuing education credits for healthcare professionals. The course is part of Bad Ad, a program designed in 2010 to raise awareness about misleading and untruthful drug ads. It's aimed at healthcare professionals, but anyone can take it, the agency said. The office has developed several case studies based on warning letters the FDA has sent to drug companies, representing common problems.SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

"We encourage medical, pharmacy, nursing and other healthcare-related schools to incorporate these cases into their coursework," Office of Prescription Drug Promotion director Thomas Abrams wrote in a blog entry on the FDA's website. "The cases cover a range of promotional materials including a website, journal ad and TV ad, and touch upon numerous promotional practices that don't comply with our regulations."

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

Stop Watching Us: The Video

Russell Brand vs. Jeremy Paxman on Newsnight 2013 [Full Interview]

Ben Goldacre writes

Dear Friends

Yesterday the pharmaceutical company LEO Pharma announced its commitment to publish results of its clinical trials dating back to 1990. They are also going to provide access to anonymised patient-level data dating back to 2000 on request. Great stuff from LEO Pharma! GSK who joined the campaign in February have been sharing their approach with LEO Pharma and with other companies who are having these discussions. These companies are moving further and further away from the obfuscating attitude of the some of the industry trade bodies who seem to want to keep secrecy as the norm.

Also this week, the heads of the European Medicines Agency wrote in the New England Journal of Medicine about the benefits that will come with increased access to clinical trial information. These include using information from past trials to improve how future trials are designed and analysed, greater opportunities to compare the effectiveness of different medicines, and the potential to avoid exposing trial participants to health risks which have already been identified in previous trials.

We have the opportunity to make sure more clinical trial information will be available in the future as the EU Clinical Trials Regulation moves onto the next stage of discussions in Europe. Will you write to your health minister to urge them to keep in the very good progress made to the Regulation so far? We don't have much time as the next stage of the process starts in the first week of November. Write to your health minister this week. You'll find sample letters in many European languages and contact details of the Ministers here.

Around the world there are people waiting to take the campaign to their countries. We need to give them materials to help them do that. We think the best way of communicating our message is to create a video that captures the voices of patients, doctors and researchers, explaining why the information on what was found in clinical trials should be available. We will subtitle the video in many languages to maximise its reach. Please donate to make that happen and tell everyone you know about this fundraising appeal.

Best wishes

Ben

http://www.alltrials.net

Please donate at https://www.justgiving.com/alltrialsappeal

David Healy writes

October 2013

  

Dear Jack:

 

Here's a recap of blog posts and other news from the past month.

Thank you to everyone who signed RxISK's drug safety petitionasking pharmaceutical giants AbbVie and Intermune to stop blocking the European Medicines Agency (EMA) from releasing prescription drug clinical trial data.

You are now part of a global movement with 6000+ signatures from 110+ countries. 

We have a brief window of opportunity before the EU judgement on EMA's data access policy to spread the message through extreme petitioning. We need your help to deliver it with style.

In the spirit of the Halloween season, why not take a photo or make a video in costume with a sign that conveys a message about transparency in clinical trial data - check out the end of this newsletter for sample messages and a fantastic costume effort from our good friend Billiam James. Post your efforts on ourRxISK Facebook page with the new Facebook hashtag feature or share on Twitter by tweeting to @RxISK using #SecretPotionsSuck.

You can also celebrate Dia de los Muertos on November 1 by setting up "ofrendas" (shrines) to those we've lost to Rx drug harm.

 

And, finally, for our friends in the United States, don't forget that October 26 is National Prescription Drug Take-back Day, when the police open drop-off sites for people to dispose of unneeded drugs.

Thank you for your support. 

 

Your feedback, as always, is greatly appreciated.

 

 

 

David Healy, MD

Are we entering the post-antibiotic era?

http://www.pbs.org/wgbh/pages/frontline/hunting-the-nightmare-bacteria/

FDA maps further clamp-down on opioid painkillers

The Food and Drug Administration has laid out a roadmap for greater strictures on the prescribing and dispensing of hydrocodone and analgesics that contain it. The move is the latest in a chain of actions taken by the FDA and other agencies to address a burgeoning U.S. crisis of addiction to opioid painkillers.

Under a plan announced by the FDA on Thursday afternoon, products containing the opioid painkiller hydrocodone, including combination analgesics such as Vicodin (which mixes hydrocodone with acetaminophen) will be classified by the Drug Enforcement Agency as Schedule II substances, with added restrictions in who may prescribe them and how they may be dispensed by pharmacies.

Here's a list of the marketed products that contain hydrocodone.

Schedule II drugs are defined as drugs "with a high potential for abuse." Medications and combination products containing fewer than 15 mg of hydrocodone per dose are currently considered Schedule III products, a classification assigned to drugs considered to have "moderate to low potential for physical and psychological dependence."

The proposed rescheduling could usher in significant changes for patients prescribed painkillers by their healthcare provider. Schedule III prescriptions (such products' current designation) may be refilled as many as five times in six months; Schedule II prescriptions may not be refilled without a newly-written prescription. Unless it's an emergency situation, a physician issuing a prescription for a Schedule II substance may not call such a prescription into a pharmacy by phone; in an emergency, the physician must send a written prescription to the dispensing pharmacy within seven days. And a pharmacist is not permitted to change the strength, dosage, formulation or quantity prescribed of a Schedule II product, nor to change the address of the consumer receiving the prescription.

The FDA recommendations come in response to a 2009 request by the Drug Enforcement Administration to consider whether further restrictions on opioid prescribing would be appropriate. The FDA's recommendations now go to the Department of Health and Human Services, and then to the DEA, before a final determination is made. The National Institute onDrug Abuse is expected to weigh in positively on the proposal.

In 2010, more than 12 million Americans reported abusing prescription painkillers, and emergency room visits for overdose of opioid medications doubled in the five years leading up to 2009, when 475,000 such visits were attributed to the medications. In 2008, opioids were the cause of close to 15,000 overdose deaths in the United States.

http://www.latimes.com/science/sciencenow/la-sci-fda-opioid-painkillers-20131024,0,5659129.story?#axzz2ihTdl0eU

Public Citizen - Unacceptable Behavior: FDA Advisory Committee Chair to Give Drug Industry Tips on Getting Drugs Approved

FDA Should Tell Dr. Lynn Drake Not to Speak at Conference or Remove Her From the Committee

October 24, 2013

Contact: Angela Bradbery (202) 588-7741; Sam Jewler (202) 588-7779

WASHINGTON, D.C. – The chair of a Food and Drug Administration (FDA) advisory committee should not advise drug company representatives at an upcoming conference how to get drugs approved by FDA committees, Public Citizen told the agency today.

According to a conference brochure, Dr. Lynn Drake, chair of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and a lecturer at Harvard Medical School, will speak in February at a conference in Washington, D.C., titled “FDA Advisory Committee Prep: Real World Best Practices to Achieve Favorable Recommendations.”

Drake plans to give a talk titled, “Pitfalls to Avoid as You Prepare for, and Present to, an Advisory Committee.” The brochure says that attendees will “hear directly from an FDA advisory committee chairperson about what mistakes she has seen first-hand that she wishes the sponsoring companies had avoided.” The conference urges potential attendees to “learn from current and former [FDA] advisory board members.” Drake’s presentation will likely be a major attraction for the pharmaceutical industry.

“The decision of a current FDA advisory committee chair to speak at this conference reflects poor judgment and seriously undermines and demeans the important FDA advisory committee process, particularly when the chair seeks to help drug companies get drugs approved,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group. Wolfe served on the FDA’s Drug Safety and Risk Management Advisory Committee from 2008-2012. “Dr. Drake’s participation in this conference raises concerns that she is approaching the work of the committee from a pro-industry perspective, rather than as an impartial expert.”

Public Citizen is calling on the FDA to tell Drake to pull out of the conference or remove her from the advisory committee. In addition, the FDA should develop a written policy for advisory committee members to curb such behavior.

Public Citizen also is questioning the FDA’s redaction of 32 items on Drake’s curriculum vitae from the webpage on which the agency has posted her CV.

The letter and brochure are available at http://www.citizen.org/hrg2166.

LEO Pharma to release clinical trial data

Published on 24/10/13 at 03:52pm

LEO Pharma has announced that it will start releasing clinical trial data from studies dating back to almost 25 years ago.

The Denmark-based firm said it is using this as a “Declaration of its support for the increased global calls for transparency coming from many quarters”, which includes patient groups, researchers and think tanks.

In practical terms this means that from 1 January next year researchers, patient associations and healthcare professionals can gain access to LEO Pharma’s clinical trial data as it gradually posts summary results sponsored by the firm, that date back to 24 years on its corporate website.

In addition it will gradually post clinical study reports (CSR) for the same time period, starting with the most recent, with all CSRs available within the next three years.

This move comes amid Sense About Science’s AllTrials campaign, established earlier this year with the support of Ben Goldacre and the BMJ among many others, which has put pressure on the industry to release all data for new and old medicines that are not in the public domain. 

A spokesman for the company told Pharmafile it was ‘considering its options’ but as yet has not signed up to AllTrials. “However [LEO] are beginning to liaise with them [the AllTrials team] and this new policy does meet many of the AllTrials recommendations,” the spokesman added.

Geraldine Murphy, managing director of LEO Pharma UK & Ireland, said: “Transparency in relation to clinical trials data is a scientific and ethical responsibility that facilitates informed healthcare decisions. As such it is core to the values of LEO Pharma and we are pleased to pledge our support.”

The firm added that it would share clinical trials data in a way that would ‘not reveal identifiable personal data’.

Ben Goldacre, author, doctor and co-founder of AllTrials said: “This is excellent news from LEO Pharma. Their commitments, and the commitments from a growing number of other companies, stand in sharp contrast to the obfuscating pharmaceutical industry trade bodies who seem to want to keep secrecy as the norm.”

This move coincides with new rules in Europe, also set to start from January next year, which will ensure pharma releases more of its clinical trial data. This is being led by the European Medicines Agency, which from 2014 will no longer recognise trial data as confidential, meaning it can be shared with the public.

Not all in pharma have been happy about this, with both AbbVie and InterMune currently suing the Agency for releasing data related to two of their medicines.

The EMA came out this week saying that transparency will be a good thing for the industry, but the European lobby group EFPIA is still calling for data disclosure to be decided by pharma, not the regulator.

It looks as if LEO could well be getting ahead of the game by signing up to a transparency agenda now and going beyond what would be expected of it, especially through producing data from nearly a quarter of a century ago.

The process will however be relatively slow, and it is not yet clear just how this will tally with what the EMA may expect.

New board

The firm said it would also evaluate each request from researchers, healthcare professionals and patient associations to receive access to anonymised patient-level data for approved products dating back to 2000. A ‘Patient and Scientific Review’ board will be established to evaluate requests for patient-level data.

The board will comprise independent researchers and representatives from patient associations, and will meet four times per year to review requests for access to clinical trials data sponsored by LEO Pharma.

Gitte Aabo, president and chief executive of the firm, said: “LEO Pharma is a patient-centric company and for us that implies being transparent about the results from our clinical trials, so that we can enable patients and healthcare professionals to make informed decisions about treatment. We recognise the public health benefits associated with making clinical trials results available.”

Ben Adams

http://www.pharmafile.com/news/181363/leo-pharma-release-clinical-trial-data?

Drug industry can profit from clinical-trial data openness, say leading regulators

The drug industry’s opposition to greater access to clinical trial data is misplaced, four senior figures in the European Medicines Agency (EMA) said today.

The agency is preparing to vastly expand the amount of information it makes available to researchers, and is close to finalizing a policy on making public data submitted to it by drug companies applying for licences for new medicines. Some elements of the pharmaceutical industry have fought back, complaining that this will release confidential data crucial to its interests and harm investment in the development of new drugs (see ‘Secrets of trial data revealed‘).

But writing today in the New England Journal of Medicine, an EMA team says that putting clinical trial data in the public domain will make it more cost-effective to develop new medicines — for example by making sure one company does not run down a blind alley already mapped by another and by providing more information that companies can use to prove the superiority of their treatments over rivals’ drugs.

“It is ironic that the organisations that most resist wider access to data are the ones that stand to benefit so much from greater transparency,” write the EMA experts, who include senior medical officer Hans-Georg Eichler and executive director Guido Rasi. Despite their roles in EMA, the authors wrote in a personal capacity.

They add: “Contrary to industry fears, we argue that access to full — though appropriate deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.”

In another article published alongside the piece by Eichler and his colleagues, Michelle Mello, a health-policy researcher at the Harvard School of Public Health in Boston, Massachusetts, and her colleagues set out a set of principles by which data can be safely and usefully shared, down to the level of information from individual patients.

“As in other areas of health care, the push for greater transparency in the area of clinical trial data appears inexorable,” they write. “The question is not whether, but how, these data should be broadly shared.”

http://blogs.nature.com/news/2013/10/drug-industry-can-profit-from-clinical-trial-data-openness-say-leading-regulators.html

Drug Swapping: Omnicare Pays $120M To Settle Kickback Charges

http://www.pharmalive.com/drug-swapping-omnicare-pays-120m-to-settle-kickback-charges?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29

It is clear that the federal government is getting a tremendous “bang for the buck” in its anti-fraud activities in health care.

There is no doubt that the federal government’s initiatives to fight health care fraud have returned large
sums of money to US taxpayers. These initiatives also improve the integrity of federal health care
programs and make a substantial contribution to their solvency. In times of constrained government
budgets, we can ill afford to have federal money wasted or stolen. It is clear that the federal government is getting a tremendous “bang for the buck” in its anti-fraud activities in health care. There
are various ways of calculating that bang for the buck, but this report makes clear that accounting for
only federal civil returns associated with FCA cases still shows a better than 16:1 return on investment,
while a more robust calculation of the federal return that factors in both civil and criminal fines and
recoveries show a far greater return. It is our estimate that a total taxpayer benefit-to-cost return from
False Claims Act law enforcement exceeds 20:1.

http://www.taf.org/TAF-ROI-report-October-2013.pdf

GlaxoChinaGate contd. - so how's business?

GlaxoSmithKline Plc (GSK) said third-quarter sales of pharmaceuticals and vaccines in China fell 61 percent after an anti-corruption probe began there in July.

Sales of consumer health-care products in China fell 29 percent, the London-based company said today in a statement. Total revenue rose 1 percent to 6.51 billion pounds ($10.5 billion), compared with 6.64 billion pounds expected by analysts.
In China, a “dramatic decline” in Glaxo’s Seretide lung drug and Flixonase nasal spray has led to a rapid acceleration in sales of AstraZeneca Plc (AZN)’s Symbicort inhaler, Barclays Plc analysts said last week. China accounts for slightly less than 3.5 percent of Glaxo’s global pharmaceutical revenue and is less profitable than its Western businesses, though the world’s most populous nation presents significant growth opportunities, the analysts said.
“It is still too early for us to quantify the longer-term impact of the investigation on our performance in China,” Glaxo said in the statement.
Allegations by China’s government that Glaxo bribed hospitals, doctors and officials prompted Witty to dispatch his head of emerging markets to China to oversee the company’s response. Some senior executives appear to have acted outside Glaxo’s processes and controls to both defraud the company and the Chinese health-care system, Chief Executive Officer Andrew Witty said on July 24.
Third-quarter earnings excluding some items were 28.9 pence a share. That compared with the average estimate of 27.2 pence from 17 analysts surveyed by Bloomberg.
The company maintained its forecast for the year as revenue from other regions offset the declining sales in China.
Glaxo shares fell 0.7 percent to 1,590 pence at 12:08 p.m. in London. Before today, the shares had returned 24 percent this year, compared with a 21 percent return in the Bloomberg Europe Pharmaceutical Index.
To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

http://www.bloomberg.com/news/2013-10-23/glaxo-s-china-sales-plunge-61-after-corruption-probe.html?

Remember

Antibiotic resistance documentary tonight in the US.

Tonight at 10:00 Eastern/9:00 Central, PBS Frontline will air a documentary about the growing threat of antibiotic-resistant bacteria. 

http://boingboing.net/2013/10/22/antibiotic-resistance-watch-a.html

Reckitt Benckiser reviews all options for drugs unit

Reckitt Benckiser, the consumer goods giant, is reviewing all options for its pharmaceuticals unit, it said on Tuesday, effectively hoisting a for sale sign on its prescription medicine business.

Shares in the maker of Strepsils and Gaviscon rose more than 6pc in morning trading after the Bank of America Merrill Lynch has valued the pharmaceuticals unit at about $3.2 billion (£2 billion)

The business centres around the drug Suboxone, which Reckitt sells as a film that dissolves in the mouth. It is used to treat heroin addiction, but now faces increased competition from cheaper copies, or generics. In the third quarter, its revenue fell 14pc to £191m.

"Critically, the decision to conduct a ‘strategic review’ of the pharmaceuticals business signals an intent to exit, in our view, and a move to resolve a troublesome valuation hangover, once and for all," said Martin Deboo analyst at Investec.

The company, which also sells cleaning products such as Varnish and Cillit Bang had said before that the right time to consider options for the pharmaceutical business would be following the launch of cheap, generic Suboxone tablets.

In February, U.S. regulators approved two generic versions of the drug.

"We expect the review to take some time and will update shareholders during the course of 2014," said chief executive Rakesh Kapoor.

http://www.telegraph.co.uk/finance/10395967/Reckitt-Benckiser-reviews-all-options-for-drugs-unit.html

Antibiotics for people, not animals - LA Times

So far this year, more than 300 people have gotten sick from bacteria called Salmonellaheidelberg. Almost three-quarters of them live in California.

The Centers for Disease Control and Prevention reported that chicken produced in three Central California processing facilities is the "likely source of this outbreak" and that the bacteria are "resistant to several commonly prescribed antibiotics."

The CDC estimates that for every reported salmonella infection, there are about 29 more unreported cases, bringing the potential toll to more than 9,000 victims. About 42% of the patients who reported their illness have been hospitalized, an uncommonly high rate that indicates this bug is more virulent than usual. According to the CDC, drug resistance "may be associated with an increased risk of hospitalization or possible treatment failure in infected individuals."

Yet on a food industry website, an associate professor of food policy at Iowa State University downplayed the risks. "The occurrence of some resistance is not concerning," he said, "as virtually every bacteria is resistant to some type of antibiotic."

Resistance may be ubiquitous, but it hasn't always been this way. It's a new normal that industrial farming practices helped create. In fact, the CDC, the Food and Drug Administrationand the World Health Organization, among others, consider widespread antibiotic resistance a cause for grave concern.

Forty years of scientific investigation demonstrate that using antibiotics to make food animals grow faster, and to compensate for the overcrowded conditions in which they are raised, breeds drug-resistant bacteria that can infect and hospitalize people.

In fact, some of the outbreak strains of this salmonella resist treatment with several antibiotics used both in poultry production and human medicine. According to the FDA, drug makers sold about 30 million pounds of antibiotics in 2011 for use in chickens and other food animals. This was a record high and nearly four times the amount sold to treat sick people.

Fortunately, we have it in our power to slow the emergence of drug-resistant bacteria.

President Obama committed during the 2012 presidential campaign to "limit antibiotic use for livestock [to] … help ensure that antibiotics are used only [to] … address diseases and health problems, and not for enhancing growth and other production purposes." The FDA is planning to ask drug companies to stop marketing antibiotics for growth promotion. The policy is now at the Office of Management and Budget, one step from being finalized. It is a good start, but it ultimately falls short of Obama's promise.

Congress can fulfill it by passing the Preservation of Antibiotics for Medical Treatment Act and its Senate counterpart, the Preventing Antibiotic Resistance Act. These landmark bills would eliminate the use of antibiotics for all production practices, not only to promote growth but also to compensate for conditions that foster disease. Importantly, the legislation would still allow sick animals to be treated with antibiotics.

Meanwhile, many consumers are taking matters into their own hands and buying meat raised without antibiotics. Parents are urging their children's school systems to do the same; Chicago and Jefferson County, Colo., are early leaders. A growing number of hospitals, including UC San Francisco's Medical Center and Burlington, Vt.'s Fletcher Allen Health Care are serving meat from animals given antibiotics only to treat illness.

Antibiotics are modern medical miracles that rendered lethal infections minor nuisances. But that 20th century success story is turning into a 21st century parable about shortsightedness and denial. The president and Congress have more than enough scientific justification to curb antibiotic overuse in food animal production. It is time for them to act.

Gail Hansen is a doctor of veterinary medicine and senior officer with the Pew Charitable Trusts' campaign to reduce antibiotic overuse on industrial farms.

Nervous?

AllTrials Update - write a letter

Dear Friends

If you live in an EU member state we need your help this week. Will you write to your country's health minister to ask your Government to support the good progress towards clinical trial transparency in the draft Clinical Trial Regulation in debates in Europe next month.

Thanks to the letters you sent to MEPs last May some very good additions were made to the draft Regulation. These new parts of the law would mean that all clinical trials taking place in Europe would have to be registered and summary results published within a year of its ending. We need to make sure that these good additions make it into the final law, and we don't have much time as the next stage of the process starts in the first week of November.

The next stage is a series of 'trilogue' discussions between the European Parliament, Commission and Council. We understand that the European Council hasn't decided its position yet. The Council is made up of representatives of all of the individual Governments of European countries so your Government's position is very important. There's no time to lose - please write to your health minister this week and urge them to support the good additions to the Clinical Trials Regulation.

What you need to do now

You'll find a sample letter here including details of the specific parts of the Regulation that we need Governments to support, and details of how to contact your health minister on this page.

If you can translate the letter into more European languages, please get in touch.

AllTrials fundraising appeal

We have launched a fundraising appeal for a video to spread the AllTrials campaign around the world. Please donate to help us produce that.

Best wishes

Ben

http://www.alltrials.net

Please donate at https://www.justgiving.com/alltrialsappeal