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Imagine if our immune systems could vanquish cancer in much the same way they take on the common cold. New research could turn such science fiction into fact.
Currently in the works are several new drugs that can order certain white blood cells - the immune system's warriors - to attack cancer cells. If they prove successful, a world free from cancer could be one step closer. Researchers are increasingly exploring how we can personalize the fight against cancer - harnessing the unique characteristics of our own bodies to beat the disease. Such personalized approaches offer our best shot at eradicating cancer - and should be at the heart of our battle plan against it. Medical science has already made progress.
Since 1990, new medicines have doubled the number of cancer survivors - from six million to 13 million. They have given patients collectively about 43 million years of additional life. These aren't years of pain and desperation. Cancer survivors add about $4.7 trillion in value to the economy just by living and working longer. Today, every dollar spent on new cancer medicines reduces spending on hospitals and doctors by $7. Yet the actual amount we spend on such treatments is small - about 1 percent of total health-care spending. Indeed, spending on innovative cancer research and therapies has already delivered a hefty return on investment. We should double down on that approach.
Step one is to put patients in charge of cancer research. How? Patients can use online communities to test treatments, design studies, and determine better ways to tackle their illnesses. They're already keeping tabs on their health with fitness monitors and tablets. Research should be shaped by these real-time, real-world experiences in combination with information about the particular genetic mechanisms that make their tumors tick. As genomics professor Eric Topol argues: "It is time for a jailbreak; it is time for the rise of the consumers to drive the future of medicine. It is their DNA, their medical data, their cellphones, and their own health at stake."
That jailbreak should include replacing one-size-fits-all research with personalized cancer studies. The Human Genome Project empowers researchers to do so. Personal genomes can now be sequenced in a few hours for under $500. Such sequencing can yield medicines that are truly personalized. Several cancer organizations, including the International Myeloma Foundation, StandUp2Cancer, and the Sarcoma Foundation of America, require researchers to look for genetic cues that could lead to cures. This should be the rule, not the exception.
These personalized approaches could also allow regulators to get new cancer medicines to market faster. Developing a new cancer medicine takes 8.8 years, on average - much longer than for other drugs. Most of this time and effort is spent testing medicines in people who researchers know won't benefit. But by focusing solely on patients and their specific cancer-causing genetic mutations, researchers could identify what therapies work early on. That could mean approving cancer therapies as fast as HIV medicines - in two to three years.
Government officials can also get personalized treatments into the hands of patients more quickly by requiring health plans to pay for them. Advances in cancer treatment are saving lives and cutting health-care costs. But many health-insurance plans haven't caught up with the times. Many cancer patients are forced to choose between a treatment that could save their lives - or one that's paid for. Insurers should instead pay for the right treatment for the right patient.
Under the health-care status quo, cancer treatment is divided up according to who gets paid. Innovations that save money are pitted against services that lose money. New "Charter Cancer Communities" can solve that problem by focusing specifically on the value of care. Like public charter schools, these communities would have greater flexibility to use and pay for the combination of treatments that deliver real value. And they'd be accountable to the member organizations and to the patients they serve. Thanks to recent advances in medical science, we're closer to a world free from cancer. If we ratchet up our investments in personalized medicine, that world can become a reality.
Read More & Comment...
On Thursday I joined a select group of FDA and healthcare policy experts at the joint FDA/Engelberg Center for Health Care Reform (Brookings Institution) to discuss, debate, and digest the many issues surrounding the thorny opportunity known as Special Medical Use (SMU).
Expertly chaired by Mark McClellan (my former boss at the FDA and the hardest working man in healthcare policy), the day was filled with honesty, ideas, identification of roadblocks – and frustration.
But all to the good.
The meeting was also filled with many senior thinkers and heavy hitters from the agency (Rachel Sherman, John Jenkins/OND, Janet Woodcock, among others) as well as senior Hill staffers, officials from the biopharmaceutical industry, BIO, PhRMA, payers, patient organizations, and academia. The list of attendees can be found here.
First of all, permit me to recommend the short briefing paper that McClellan’s team developed in advance of the meeting, “Special Medical Use: Limited Use for Drugs Developed in an Expedited Manner to Meet an Unmet Medical Need.” Worthwhile reading both as a primer and a guide to many of the regulatory quandaries surrounding SMU.
The meeting began with McClellan commenting that we needed to “channel PCAST” and making the key distinction (regularly confused) that the difference between special medical use (from a labeling perspective) and REMS – is that REMS is for known safety risks.
And then came Janet.
Her remarks focused understanding SMU along the “safety and certainty” continuum. SMU medicines are for sub-segments of a patient population (with a serious and life-threatening disease) that are not effectively served by current therapies. “There’s a difference between headaches and HIV.” And that wasn’t a throwaway line. In fact, there was zero mention or acknowledgement that SMU should be a pathway exclusively for anti-infectives. Janet strongly affirmed that the FDA has no interest in interfering in the practice of medicine. To the contrary, she believes the best way to ensure that SMU products are used appropriately is through clear and distinct labeling – special logo, etc.
This makes perfect sense and is a logical extension of the agency’s Safe Use of Drugs initiative.
Janet also raised the issues of SMU products and industry promotional practices. Her feeling is that (as with other Breakthrough Designation programs) that pre-view of all marketing materials would be an SMU prerequisite. She also raised the interesting question of seeking to limit on-label communications in order to drive “appropriate messaging from launch because appropriate messaging leads to appropriate use.”
Tom Abrams, call your office.
Janet also noted the fear of many in industry that the FDA would “deem” an SMU designation. She made it clear that would not be the case.
After Dr. Woodcock’s opening keynote, the first panel of the event focused on “The Special Medical Use Pathway Proposal.” The panelists were Jim Greenwood (BIO), John Castellani (PhRMA), Jack Lasersohn (The Vertical Group), Margaret Anderson (FasterCures), and Jeff Allen (Friends of Cancer Research).
And, while there were no fireworks – there was a degree of discomfort – specifically on SMU and legislation, regulatory authority, and therapeutic areas of use.
Here’s how Steve Usdin at BioCentury saw it:
BIO, PhRMA split on special use pathway
The leaders of the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America staked out separate positions on the creation of a Special Medical Use pathway proposed by the President's Council of Advisors on Science and Technology and senior FDA officials …
BIO President and CEO James Greenwood said the group's board "strongly approves" of SMU, endorses congressional action to create the pathway and feels it should be "broadly applied" to drugs for a wide range of diseases. John Castellani, PhRMA's president and CEO, declined to endorse creation of an SMU pathway and said FDA has sufficient authority to approve drugs for special populations, though he stressed the urgency of facilitating development of new anti-infective drugs. Members of Congress have indicated that enactment of legislation creating an SMU pathway is contingent on unanimous support from industry, so PhRMA's skepticism about the need for an SMU pathway could scuttle the concept.
While the general sense of Usdin’s comments is correct, it may not be quite so black and white.
Both Greenwood and Castellani support the concept of SMU. And that’s an important point of departure. Greenwood, while supporting the concept of legislation, believes that the FDA already has the regulatory authority to create a Special Medical Use pathway and the ensuing labeling for such products. He said that, rather than pushing for actual legislation, that a “sense of Congress” might be a better idea.
Dr. Woodcock, call your lawyers.
Castellani agreed that the agency already as the authority to move forward. So there’s important convergence there. But he was less clear on the issue of an SMU pathway that went beyond anti-infectives. I specifically asked him if he felt the SMU pathway should be limited to anti-infectives. His answer was to reiterate PhRMA’s concerns about “direct or indirect” impact on the practice of medicine and possible agency hindrance of appropriate promotional communication.
Both Margaret Anderson and Jeff Allen feel that the SMU pathway should be open to any appropriate therapeutic area. Jeff Allen made a key point, that the SMU pathway is possible because of advances in science. It sounds like a simple point – and it is – but it’s important to recognize that SMU is the next logical step towards personalized medicine.
Margaret Anderson also got real by pointing out that, minus additional budget, the FDA will only be able to go so far. “How much innovation,” she asked, “can the agency be expected to handle?”
Indeed.
The general consensus was that SMU should be piloted with anti-infectives – but proceed rapidly to where the need is the greatest. Bravo – but highly subjective.
John Castellani, call your office.
Panel Two operated under the moniker, “Implementation and Impact of Special Medical use Products in Clinical Practice” – but this was really the payer panel.
Sam Nussbaum (WellPoint) brought the urgent issue of patient outcomes into the conversation. His point was (per reimbursement) that if the SMU process works as designed (limited use with an enhanced risk/benefit profile in a defined sub-population) that they would be swiftly tiered for reimbursement.
Pursing the topic of the role payers have in outcomes, Ed Septimus (HCA Healthcare) stated that, “Stewardship is resource intensive.” True – but lack of stewardship is even more costly in terms of scarce dollars and clinical sense – and patient lives. Septimus also introduced the concept of mandatory patient registries.
I asked the panel if, as part of the regulatory process, the FDA should mandate patient registries for SMU medicines. There was an uncomfortable silence.
Gerald del Pan, call your office.
Panel III: “Postmarket Considerations to Promote Safe Use and Continued Evidence Development of Special Medical Use Products” opened with Preeti Pinto (former AZ compliance chief and now consultant extraordinaire to the regulatory stars) stating that, “Marketers will promote the product to the full extent of the label.” No surprise there, but a real issue when it comes to promoting safe use of SMU medicines. Can marketers self-regulate? Is that even feasible? Short of an OPDP SWAT team for SMU medicines (with the authority to apply harsh penalties) how can marketers (per Preeti’s prescience) be made to “do the right thing?” What are the appropriate tools for post-marketing surveillance and how can they be validated?
Rob Califf (Duke Translational Medical Institute and Duke University Medical Center) pointed out that the label has become nothing more than a tool for legal protection – dismissing any future utility. But, in a post Wyeth v. Levine world, with preemption off the table, perhaps now is precisely the right time to revisit the public health utility of the PI.
Perhaps, as part of the SMU pathway, the FDA should adopt the EPARS (European Public Assessment Reports) system. The European Medicines Agency (EMA) publishes an EPAR for every medicine granted a central marketing authorization by the European Commission. EPARs are full scientific assessment reports of medicines authorized at a European Union level.
Rachel Sherman, call your office.
An “almost” consensus of the meeting was the SMU pathway should proceed apace with anti-infectives as the pilot program and under existing regulatory authority. Almost. Maybe.
Read More & Comment...Yesterday I participated in the Brookings Institution/FDA meeting on Special Medical Use. I am gathering my notes and will have a more complete report ready for Monday.
In the meantime, here is an interesting take on the issue from the pages of Specialty Pharmacy Times.
FDA’s New Expedited Approval Program Provides Major Communication Breakthrough for Industry
Drugs that show a clear or substantial benefit to patients in the earliest stages of clinical trials can now reach the market more quickly, thanks to the FDA’s new Breakthrough Therapy designation. The expedited pathway, introduced by the Food and Drug Administration Safety and Innovation Act of 2012, has the potential to shave off nearly 75% (or by some accounts, nearly 2 years) of the time it typically takes the FDA to review a new drug application.
One of the major innovations of the expedited drug development process appears to be that drug companies now have direct access to something that previously eluded them: FDA officials. According to Reuters, efforts to bring promising therapies to market have been well-coordinated through the use of these pathways, and communications “that might typically take weeks and months” have been occurring more quickly, with fewer gaps between interactions.
The FDA began granting breakthrough designations in January 2013. To date, the agency has received 77 requests. Of these, the regulatory body has granted 25 designations and denied 24. Kalydeco (ivacaftor), Vertex’s cystic fibrosis drug, was approved under the breakthrough designation pathway earlier this year. Anticipated blockbusters such as Genentech’s obinutuzumab and Janssen/Pharmacyclics’ ibrutinib have snagged breakthrough designations as well. Obinutuzumab was granted the designation for the treatment of chronic lymphocytic leukemia (CLL), and ibrutinib was granted 2 breakthrough designations: one to treat patients with CLL and the other for patients with mantle cell lymphoma.
Although getting treatments to patients more quickly is definitely a good thing, a recent blog from Context Matters points out that, based on its calculations, the FDA’s previously established programs to expedite therapies (including Fast Track, Accelerated Approval, and Priority Review) have not produced lasting improvements in approval time. “Based on our preliminary analysis, in 2008 the average cycle time for ‘Priority’ was 10.1 months, versus the ‘Standard’ which was 21.2 months. In 2011, the average cycle time for ‘Priority’ was 19.5 months, versus ‘Standard’ which was 17.5 months,” the blog authors wrote. “What’s interesting here is that over time the fast lane has apparently become just another standard lane; in 2011 it was actually even slower.”
The group at Context Matters compared the process in the United States to that of the one used by the European Medicines Agency (EMA) and concluded that despite not having “fast” or “standard” designations, the EMA approval process took an average of just 3.5 months during 2012.
The FDA needs to have the proper infrastructure and support to successfully reduce approval times, says Peter Pitts, a former head of communications for the FDA who is a board member of Context Matters and co-founder of the Center for Medicine in the Public Interest. “Clearly, when you are looking at products that have less data behind them, you need more senior people who can devote greater resources to studying them, and that also takes time away from other programs that the agent needs to review,” Pitts told Specialty Pharmacy Times. “It’s one thing to give the FDA more authority, it’s another thing to give the FDA greater responsibility, but if you don’t give them the resources to get it done, to a large degree it is just rhetoric.”
Despite the improvements in communication and collaboration between drug developers and the FDA, manufacturers still must overcome many hurdles on the way to getting therapies approved by the agency. Sponsors must have more resources available in less time in order to push their therapies through the abbreviated regulatory process, and because many of the drugs being submitted for review under the new designation are targeted therapies, they frequently must be developed in concert with a companion diagnostic test. Such diagnostics would have to be approved separately by the FDA’s Center for Devices and Radiological Health, and guidance governing their development has been shaky so far.
Once therapies gain approval through the breakthrough therapy program, they still may face challenges in getting to patients as health plans may be reluctant to provide reimbursement for therapies with a limited amount of evidence regarding patient outcomes. Other issues that may thwart successful market penetration of drugs traveling through this pathway include timing of facility inspections and obtaining drug approval in other countries (where the breakthrough designation is not recognized or accepted). A lack of FDA resources may also affect the success of the breakthrough pathway in getting therapies to patients with few or no treatment options.
But, speed to market isn't the only metric that matters, Pitts points out. "Breakthrough designation doesn’t always mean the product gets approved...sometimes it means that because you fail faster, you don’t waste money on programs that don’t pan out."
The Washington Post reports Capital City Care dispensary sold Washington DC’s first legal marijuana “in at least 75 years” on Monday. The sale is a result of a “15-year struggle to legalize medical marijuana in the district,” the culmination of a battle that “dates to the mid-1990s, when HIV/AIDS activists first fought to put medical marijuana on the citywide ballot.” About 70% of DC voters approved a 1998 legalization initiative, only to have it squashed by Congress for over a decade. But after Congress lifted the restriction in 2009, it still took several years for the city government to establish a “strict regulatory and licensing regime limited to city residents with specific chronic illnesses,” while also minimizing the “risk of future federal intervention.”
Read More & Comment...The New England Health Institute has released a new report calling on public and private policymakers to adopt six “priorities for action” to improve the way patients take their prescription medicines across the US.
NEHI has created six “priorities for action” to improve the way patients take their prescription medicines across the US. They are:
1) Promote sharing of best practices and lessons learned from pilots of new medication management techniques
2) Support large-scale implementation of promising, evidence-based “tactics” for improved medication management
3) Continue development of metrics of medication use that will spur adoption of proven medication management strategies
4) Support continued rapid adoption of electronic prescribing and electronic medical records with capabilities that support evidence-based interventions for improved adherence
5) Continue to improve Medication Therapy Management services in Medicare Part D including improvements in program services and targeting; consider wider adoption of medication management by other health care payers
6) Integrate medication adherence research, policy development and advocacy with broader efforts that aim to improve use of medicines, including those focused on patient safety
The report concludes:
Proponents of better patient adherence should rally behind a comprehensive vision of good medication use that encompasses interventions to promote adherence, and promote a vigorous agenda for policy change that will create incentives for proven adherence interventions.
Words to the wise.
One major problem is the so-called Independent Payment Advisory Board. The IPAB is essentially a health-care rationing body. By setting doctor reimbursement rates for Medicare and determining which procedures and drugs will be covered and at what price, the IPAB will be able to stop certain treatments its members do not favor by simply setting rates to levels where no doctor or hospital will perform them.
There does have to be control of costs in our health-care system. However, rate setting—the essential mechanism of the IPAB—has a 40-year track record of failure. What ends up happening in these schemes (which many states including my home state of Vermont have implemented with virtually no long-term effect on costs) is that patients and physicians get aggravated because bureaucrats in either the private or public sector are making medical decisions without knowing the patients. Most important, once again, these kinds of schemes do not control costs. The medical system simply becomes more bureaucratic.
The nonpartisan Congressional Budget Office has indicated that the IPAB, in its current form, won't save a single dime before 2021. As everyone in Washington knows, but less frequently admits, CBO projections of any kind—past five years or so—are really just speculation. I believe the IPAB will never control costs based on the long record of previous attempts in many of the states, including my own state of Vermont.
Read the full piece in the Wall Street Journal.
Read More & Comment...
Speaking of clinical trial data transparency – here’s an excellent analysis from the August edition of the Burrill Report ...
Fight for Transparency Heats Up: Industry turns to courts to stop policy in EU, offers own approach
Daniel S. Levine
Tom Jefferson had nagging concerns about his review for the Cochrane Collaboration of clinical studies of the flu drug Tamiflu, but they crystallized in 2009 when a Japanese pediatrician raised a question about the work via email. The doctor wanted to know why the review included eight unpublished trials that Jefferson and his colleagues hadn’t seen, and had only been included as summaries in another study funded by the drug’s producer Roche?
The solution seemed simple enough. Jefferson, an epidemiologist based in Rome who was conducting the updated analysis for the Cochrane Collaboration, an independent group that provides guidance to healthcare professionals on the use of drugs, would reach out to the authors of the studies and get them. But the authors either told him they didn’t have the data, said they had never seen the data, or ignored him completely. When he asked Roche for the studies, it said it would provide them, but insisted at first that he sign a confidentiality agreement, a condition that he found unacceptable.
The controversy came against a backdrop of worldwide fear of a global pandemic of bird flu that sent the World Health Organization, the Centers for Disease Control and Prevention, and governments around the world spending billions of dollars to stockpile Tamiflu. Despite the spending, Jefferson says there were questions about whether the drug did anything to prevent transmission of flu, minimize complications, or whether the health benefits the drug provided justified the risks of using it. Roche, in a statement posted on its web site and updated at the end of February 2013, said that it had disagreed with the analysis plan Cochrane Collaboration shared with it because it was at odds with how Tamiflu has been reviewed and approved by regulatory authorities in more than 80 countries. The company said it stood by the “robustness and integrity” of its data supporting the safety and efficacy of the drug.
“The fight for the last four years hasn’t been so much for clinical study reports,” Jefferson says, “but to have clinical study reports without having to sign confidentiality agreements, funny handshakes, rolling up our trouser leg, and so on.”
The four-year battle to obtain clinical trials data—he believes that there have been 123 studies (74 of which Roche sponsored)—has made Jefferson a flag bearer in an international fight over clinical trials data transparency. The controversy, which is by no means limited to Tamiflu and Roche, is now reaching a critical point. A legal battle is underway in Europe over a European Medicines Agency transparency policy expected to take effect at the start of 2014 that would make public clinical trial data once a drug is approved. At the same time, in the United States, the Institute of Medicine is at work on a consensus study on the issue and the U.S. Food and Drug Administration is seeking comment on a clinical data transparency policy of its own.
Much is at stake as the policymakers embrace comparative effectiveness and the advent of Big Data provides a new means to ferret out untapped information hidden within clinical study reports—the detailed narrative reports at the individual patient level that can run to tens of thousands of pages in a single trial.
Proponents of clinical data transparency argue that it will provide doctors with greater insight into the safety and efficacy of the drugs they prescribe, improve care, cut waste, and minimize scientific misconduct and fraud. Peter Doshi, a post doctoral comparative effectiveness researcher at Johns Hopkins University, who is also working on the Tamiflu review for the Cochrane Collaboration, points to a list of blockbuster drugs that were marketed only to have significant health risks come to light through academicians analyzing clinical trials data. “The whole system has depended on trust in medicine, trust in people to report properly, trust in people to have enough information to credibly analyze trials,” he says. “We know enough not to be so trusting anymore.”
Industry, while not of one mind, says that in principle it doesn’t oppose transparency, but expresses concerns about how it is done. These concerns include the threat to confidential commercial information, the challenge to the authority of regulators, the risk to patient privacy, and the opening of the data to inappropriate uses that could lead to the publication of misleading results and public health scares.
Lawsuits in Europe
In May, the General Court of the European Union prohibited the European Medicines Agency from releasing data from two AbbVie and Intermune trials in an interim ruling, part of a challenge by the two drugmakers to the agency’s decision to grant access to information the companies provided as part of their market approval applications. The challenge is the first to be made to the EMA’s three-year old access-to-documents policy.
Since November 2010, the Agency has released more than 1.9 million pages in response to such requests. The legal battle involves documents relating to AbbVie’s rheumatoid arthritis drug Humira and InterMune’s Esbriet, a treatment for idiopathic pulmonary fibrosis, an unexplained chronic and progressive scarring of the lungs. In both cases, competitors of the companies were seeking the data.
“Biopharmaceutical companies support responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research,” said Matt Bennett, senior vice president for the Pharmaceutical Research and Manufacturers of America in a statement at the time. “Unfortunately, the EMA’s current and proposed policies fail to respect these principles.”
The ruling comes amid increasing pressure from medical journals and patient advocates on pharmaceutical companies to provide complete transparency and make public all of their clinical trials data. It also comes as the EMA readies implementation of a new policy to proactively publish data from clinical trials supporting the approval of new drugs once a decision has been made. The EMA said it would continue the process of drafting its policy on publication of clinical trials data.
Ben Goldacre, author of “Bad Pharma” and co-founder of the AllTrials campaign, which seeks publication of all results from all clinical trials, called the ruling “a disgrace.” “There is no justification for withholding information about the methods and results of clinical trials from doctors, researchers, payers and patients, who need all the information on a medicine to make truly informed decisions,” he says.
The EMA says it welcomes the opportunity for legal clarification of the concept of commercially confidential information, but expressed “regret” over the decision to grant interim relief to AbbVie and InterMune.
FDA, IOM, weigh transparency
In the United States, although efforts to bring about transparency have moved slower, they are advancing. In October 2012, the Institute of Medicine held a two-day workshop to explore the benefits of sharing clinical research data, the issues surrounding it, and how best to do so. The IOM is now working on a consensus study that some hope could provide a roadmap for the development of a clinical trials data transparency policy in the United States.
A group of leading pharmaceutical and biotechnology companies has been involved in the IOM process and issued a press release hailing the effort. “This industry group is strongly in support of enhanced access by third party research to clinical trial data generated by industry and academia in a manner that ensures that patient confidentiality is preserved, scientific integrity is maintained, and intellectual property rights and confidential company information are protected,” they said in a joint statement.
The Food and Drug Administration is seeking public comments through August 5 on a policy to make available de-identified and masked data derived from medical product applications. But advocates of transparency say such data will be of limited utility because the policy under consideration would de-identify it and remove the data’s link to a specific product, study, or application.
Peter Pitts, president of the Center for Medicine in the Public Interest and chairman of a conference on clinical trials data transparency held by FDANews July 23-24, says it’s “a non-arguable fact that FDA is at the nexus of vast amounts of clinical data that if it was appropriately shared it would be of tremendous value.” He says that sharing information, among other things, could help companies fail faster, which would save a lot of money and allow for reinvestment of diminishing resources. But such an effort, he says would require information technology resources the agency is without, decisions on what is and isn’t redacted, discussions about intellectual property rights and commercial confidentiality, and funding for it all.
“We’ve come to the point now, relative to clinical trials data, that transparency is a good thing. The question now becomes, ‘How do you accomplish that and what exactly does transparency mean? And how quickly does it become transparent? And how much of it becomes transparent and how much of it remains confidential? Is it transparent through corporate entities, or is it transparent through a consortium of corporations? Is it transparent through a government organization? And who ultimately decides? Can people opt out? And if people opt out, can you really have transparency?’” says Pitts. “They are all very tough questions.”
(Note: For more on the FDA News conference, see Cry “havoc,” and let slip the dogs of data transparency.
Progress, but no victory
Four years after Jefferson began his efforts to access clinical study reports from Roche and GlaxoSmithKline, which produces the Tamiflu competitor Relenza, both of which are in the class of drugs known as neuraminidase inhibitors, it is Roche and GSK that arguably have the clearest defined and most advanced efforts to provide clinical trials data to outsiders.
Roche has complied with the original request the Cochrane reviewers made in 2009, although the researchers continue to pursue access to additional trials data of which they subsequently learned. The Cochrane Collaboration expects at the start of 2014 to publish a new review of neuraminidase inhibitors based on 23 clinical studies on Relenza and up to 20 studies on Tamiflu.
In February, GSK announced it had signed on in support of the AllTrials campaign and has vowed to publish clinical trials data of all approved drugs dating back to 2000, the date the company was formed through the merger of Glaxo Wellcome and SmithKline Beecham.
“We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment,” Patrick Vallance, President, Pharmaceuticals R&D, GlaxoSmithKline, said in announcing support for the campaign. “Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research. All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organizations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit.”
In response to questions from The Burrill Report, GSK said it believes a broader solution for providing access to trial data from across the research community needs to be developed and it has been in discussion with trials sponsors from industry, academia, and research charities working in partnership to create one. GSK says one solution would be the establishment of an independent data custodian to which research sponsors would deposit anonimized data after a project has been completed and clinical studies are published. Researchers could then submit scientific proposals and analysis plans to independent custodian to request access.
The Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations at the end of July jointly issued a list of principles for clinical trial data sharing. They call for a voluntary plan that would make data available to only to “qualified” researchers who sign non-disclosure agreements. They say they would only share data for which they have the informed consent of study participants to do so.
(Note: The full principles can be found on the PhRMA website. PhRMA said implementation of the commitments in the principles will begin on January 1, 2014.)
Companies will start reviewing requests for data from researchers at that point, but Castellani said companies will need to take into account patients’ informed consent. He said it will not be possible to share data from many earlier trials because patients participating in them did not consent to such release.)
But advocates worry that the victories in studies extracted from pharmaceutical companies to date may be short lived, in large part due to the legal battle in Europe over the EMA’s transparency policy. “Societal expectations have dramatically moved in a direction of greater transparency, but there remain serious risks to the process that could potentially derail a lot of the progress that has been made,” says Johns Hopkin’s Doshi. “The progress we’ve seen with Tamiflu may have been a one-off victory for what otherwise may be a return of data secrecy. Many people think the goals of transparency have been achieved, but they have not.”
Read More & Comment...ANOTHER DAY, ANOTHER POLLING NADIR FOR OBAMACARE - This time, the bad news for the White House came from CBS, which found that 39 percent of respondents want the law wiped from the books, the highest percentage since the broadcaster began asking the question. That's compared to 36 percent who want to keep or expand the law. Recent polls have tended to show the law mired in continued uncertainty and unpopularity among Americans, a dynamic supporters hope will start to shift once the key benefits of the law come online in January.
Read More & Comment...
Yesterday I had the privilege to chair the Clinical Trials Disclosure and Transparency Summit.
Here are my opening remarks:
Simplistic solutions to important public health issues are generally wrong, often deleterious to the issue at hand --and often hide political versus public health agendas. Or as Henry Kissinger once said:
”The real distinction is between those who adapt their purposes to reality and those who seek to mold reality in the light of their purposes.”
And so, with that introduction, welcome to the Clinical Trial Disclosure and Transparency Summit.
In a recent op-ed in the New York Times, biasedly titled, Health Care’s Trick Coin, Ben Goldacre (the author of the neutrally titled book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, made a number of serious allegations – and factual mistakes in his discussion of clinical trial transparency – specifically that the Clinicaltrials.gov registration requirement in FDAAA isn't being implemented and that only “full transparency and publication of clinical trial will address the issue.” It’s not so simple – and the facts matter.
As the former senior government official in charge of clinicaltrials.gov, it’s important to look at the facts – and the numbers.
In 2000, the National Institutes of Health (NIH) launched ClinicalTrials.gov to provide public access to information on clinical studies. Although it initially contained information primarily on NIH-funded research, it has been expanded to include both publicly and privately supported clinical research.
Since the launch of the site, it has been enhanced to significantly increase data sharing. The ClinicalTrials.gov database includes information on nearly 140,000 clinical trials in all 50 states and 182 countries.
Is anyone accessing this wealth of information? Yes! The NIH reported last year that ClinicalTrials.gov “receives more than 95 million page views per month and 60,000 unique visitors daily.
Facts do not cease to exist because they are ignored. Mr. Goldacre should realize that reality, although sometimes inconvenient to ones argument, remains reality.
As we progress through the next two days, here are some issues we will consider:
· The FDA is at the nexus of vast amounts of patient-level clinical data – what role will transparency play in making such information available? How might the agency accomplish such a task, how would it be funded – and where does such an initiative fall on the agency’s long list of urgent priorities?
· How will current AbbVie/Intermune legal decision in the EU impact transparency issues here at home?
· How will the IOM report impact how we view transparency going forward? Indeed – how will the IOM move forward on this issue – or will it?
· Should transparency be a government dictate or a working collaboration between interested parties both private and public – and what role should patients play. Should there be formalized transparency consortia? Should it be global?
· What are the implications for intellectual property and the connected question of incentivizing (or dis-incentivizing) investment in innovation? Is transparency a Trojan horse to attack patents and intellectual property rights?
· How can we avoid making transparency a game of “gotcha” such as what happened at the 2010 Avandia hearing where a grandstanding Henry Waxman pointed his finger at the GSK research chief and stridently said, “do you swear under oath that you will make all clinical trial data available? Only to get the embarrassing response, “Congressman, it’s available right now at www.gsk.com.”
· What about the availability of data from unpublished negative trials? Why aren’t payers asking for these before they make reimbursement decisions? For those of you following the debate over FDAMA 114 and the use of pharmaco-economic data for reimbursement decisions, this shouldn’t be an unfamiliar discussion. Can a free-market solutions drive transparency?
· Can transparency become a competitive advantage as well as a public health imperative?
After all, good things happen when everybody wins.
Ladies and Gentlemen – start your engines.
The Summit’s first speaker was Dr. Richard Moscicki, CDER’s new Deputy Director for Science Operations. His presentation focused on the transparency dichotomy of “the promise versus fear and loathing.”
As to “why” transparency, he offered reproducibility, re-analysis the potential to identify new information (placebo effects, biomarkers, endpoints, trial designs).
And then his talk got interesting. He laid it on the table that one group that is silently against transparency is academics – because they don’t want to be cornered into making studies public if it impacts their ability to publish.
The FDA’s impediments to data sharing, according to Moscicki are (1) Legal (data ownership, HIPAA/privacy, proprietary information), (2) technical/practical (format, data standards, CDISC, redaction), (3) Resources and, (4) the agency’s need to focus on its key mission.
Per that last point, he honestly shared that the FDA does not view (at least at as of right now) the issue of clinical trial data transparency as a key agency agenda item – unless there was move to move it to the head of the regulatory queue via user fees. (That would be DTUFA – Data Transparency User Fee Act. Folks – you heard it here first.)
But transparency is important and, per Moscicki, “inevitable” – and to that end he discussed the agency’s recent Federal Register Notice (Masked and De-identified Non-Summary Safety and Efficacy Data).
FDA invites comments on the issues it should consider with respect to the availability of clinical and pre-clinical study data after steps have been taken to “de-identify” it by removing any personally identifiable information and “mask” it by removing data that could link it to a specific application or sponsor. Specifically, the agency is interested in comments from the public on the following topics:
– What factors should be considered in masking study data (e.g. should certain data fields be removed or modified; number of different products to pool within a class)?
– Should there be any limitations on the agency’s ability to make masked data available?
– In addition to current FDA requirements to remove any names and other information that might identify patients, what other information should FDA consider when de-identifying the data?
– Would regulatory changes facilitate the implementation of this proposal?
– In what situations would disclosing masked data be most useful to advance public health?
Moscicki stressed that FDA’s approach has been under development for several years and
* It is not linked to EMA proposal;
* FDA is not contemplating routine preparation and release of de-identified and masked clinical and non-clinical study data;
* The agency is encouraging independently organized efforts to create, curate and share clinical trial datasets from all sources.
Dr. Moscicki’s complete PowerPoint presentation can be found here.
Next up on the agenda was Sir Alasdair Breckenridge, former Chairman of the MHRA and currently the Chair of United Kingdom’s Department of Health Emerging Science and Bioethics Advisory Committee.
Sir A. challenged the assemblage with the statement that transparency is “a process without a beginning or an end. It is a continuum.” And, “Transparency is like feeding a hungry dog – you more you give it, the more it wants.”
Cry havoc – and let slip the dogs of data transparency.
His presentation focused on four key questions:
(1) Should the public have access to data on which regulatory decisions are taken?
(2) What are the advantages and disadvantages of increased transparency?
(3) What are the key distinctions between transparency and communication (specifically the issue of public health literacy and numeracy – and the “road testing” of released information)?
(4) Will increased transparency lead to increased trust in regulators and industry?
On that last point, Dr. Breckenridge pointed out at increased transparency does not lead to increased trust. Trust depends on perceptions of honesty and competence, and transparency may expose inherent inefficiencies in a system. And that’s a good thing – if we really mean to make the most of transparency.
Transparency cannot be “for thee but not for me.”
He offered five keystones for moving forward:
(1) Agreement on timing of release of information
(2) Agreement on nature of information to be released
(3) Standards of protection of personalized data
(4) Standards for meta-analyses
(5) Rules of engagement for observational studies
He also discussed the EMA’s mad dash towards data transparency and the severe blow it was dealt by the legal victory of AbbVie and Intermune. A lesson that should be noted by the Ben Goldacres's of the world -- and the British Medical Journal.
Sir Alasdair’s PowerPoint presentation can be found here.
Maybe the FDA’s incremental and collaborative approach is best after all. Slow and steady ain’t sexy – but it generally works best -- and is in the best interest of the public health.
Read More & Comment...According to a report in the Pink Sheet, “Spurred by increasing stakeholder requests for clarity, FDA may be moving toward developing guidance on how and when drug firms can provide health care economic data to formulary managers.”
Per an FDA spokesperson “This is one of the areas that is of interest to FDA and we are discussing possible guidance development.”
The guidance could help clarify the regulatory parameters around the provision in the FDA Modernization Act of 1997 that allows drug companies to proactively disseminate health care economic information to formulary committees within certain limitations. Sec. 114 requires that such information be supported by “competent and reliable scientific evidence” and that any health economic information disseminated must “directly relate” to a drug’s approved indication.
As payers push for more information on the cost effectiveness of drug treatment, manufacturers are taking a closer look at Sec. 114 and are seeking direction from the agency on how it could be used. FDA Office of Prescription Drug Promotion Director Tom Abrams recently acknowledged heightened stakeholder interest in guidance on appropriate communications under FDAMA Sec. 114. “We know that’s a hot topic – what goes to formulary committees and similar bodies,” he said on June 25at the DIA annual meeting in Boston.
Abrams identified dissemination of health care economic information as one of four topics the agency is “exploring for future guidance development.” The other three are medical practice guidelines, comparative claims and “scientific exchange.”
Abrams’ DIA remarks are the first inkling of Agency movement since late 2011 when, according to a notice in the Federal Register:
The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange. FDA is interested in obtaining comments and information regarding scientific exchange about both unapproved new uses of products already legally marketed (“off-label” use) and use of products not yet legally marketed for any use.
And the issue of “scientific exchange” comes front and center. According to the FR notice, To assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange.
The FR notice puts this request into perspective:
On July 5, 2011, a citizen petition was submitted by Ropes & Gray and Sidley Austin LLP on behalf of seven product manufacturers (Petitioners): Allergan, Inc.; Eli Lilly and Co.; Johnson & Johnson; Novartis Pharmaceuticals Corp.; Novo Nordisk, Inc.; Pfizer, Inc.; and sanofi-aventis U.S. LLC under 21 CFR 10.30. The citizen petition requested that FDA clarify its policies for drug products and devices governing certain communications and activities related to off-label uses of marketed products and use of products that are not yet legally marketed for any use. Specifically, the petition requests clarification in the following areas:
1. Manufacturer responses to unsolicited requests;
2. Scientific exchange;
3. Interactions with formulary committees, payers, and similar entities; and
4. Dissemination of third-party clinical practice guidelines.
For some time, FDA has been considering these issues and is currently evaluating our policies on sponsor or investigator communications and activities related to off-label uses of marketed products and use of products that are not yet legally marketed for any use. We have been considering what actions to take in the areas specified by the petitioners with respect to manufacturer responses to unsolicited requests; interactions with formulary committees, payors, and similar entities; and the dissemination of third-party clinical practice guidelines.
Specifically, the FDA asks:
• How should FDA define scientific exchange?
• What types of activities fall under scientific exchange?
• What types of activities do not fall under scientific exchange?
• Are there particular types and quality of data that may indicate that an activity is, or is not, scientific exchange?
• In what types of forums does scientific exchange typically occur? Should the use of certain forums be given particular significance in determining whether an activity is scientific exchange or an activity that promotes the drug or device? If so, which forums?
• What are the distinctions between scientific exchange and promotion? What are the boundaries between scientific exchange and promotion?
• Generally, who are the speakers involved in scientific exchange, and who is the audience for their communications?
• Should the identity of the participants (either speakers or audience) be given particular significance in determining whether an activity is scientific exchange or an activity that promotes the drug or device? If so, which participants would be indicative of scientific exchange and which would be indicative of promotion?
• How do companies generally separate scientific roles and promotional roles within their corporate structures?
• How should the Agency treat scientific exchange concerning off-label uses of already approved drugs and new uses of legally marketed devices? Please address whether there should be any distinctions between communications regarding uses under FDA-regulated investigation (to support potential approval) and communications regarding uses that are not under express FDA-regulated investigation.
• How should the Agency treat scientific exchange concerning use of products that are not yet legally marketed (that is, products that cannot be legally distributed for any use outside of an FDA- or institutional review board (IRB)-approved clinical trial)?
• Should investigational new drugs and investigational devices be treated the same with respect to scientific exchange? Why or why not?
• Under 21 CFR 812.7(b), an investigational device is considered to be “commercialized” if the price charged for it is more than is necessary to recover the costs of manufacture, research, development, and handling. Similarly, FDA considers charging a price for an investigational drug that exceeds that permitted under its regulations (generally limited to cost recovery) to constitute “commercialization” of the drug (see 74 FR 40872 at 40890, August 13, 2009; 52 FR 19466 at 19467). What other actions indicate the commercialization of drug and/or device products? If there are differences in the steps taken to commercialize drug products and the steps taken to commercialize device products, either before or after approval, please explain these differences.
A lot of questions and, it seems, a lot of potential regulatory mission creep.
Relative to, “Interactions with formulary committees, payors, and similar entities,” the door is now also open for debate on FDAMA Section 114 and health economic data.
There is no on-the-books draft or final guidance on Section 114. It’s been 14 years since the initial language. Health-related quality of life claims are considered under the established "adequate and well-controlled trials" standard.
Some background to put this into perspective:
To address concerns that FDA regulations were limiting the dissemination of outcomes research, Congress added Section 114 to set a new, less stringent standard applicable to promotional dissemination of health care economic information to MCO formulary committees: "competent and reliable scientific evidence."
Even though there is no FDA guidance to explain the agency's understanding "competent and reliable scientific evidence,” PhRMA developed a draft guidance, which was submitted to the FDA in June 1998. In its draft, PhRMA sought input from the International Society for Pharmacoeconomics and Outcomes Research, the Society for Medical Decision Making, the Academy of Managed Care Pharmacy, the American Pharmaceutical Association, and other groups.
In its submission to the FDA, PhRMA explained the history behind Section 114 and proposed guidance on the following terms used in the new law:
- Health care economic information.
- Managed care or other similar organizations.
- Formulary committee or other similar entity.
- Directly related to an approved indication.
- Competent and reliable scientific evidence.
The PhRMA proposal took an approach to interpretation consistent with Congress's intent that Section 114 would increase the dissemination of outcomes research information by product manufacturers to MCOs. PhRMA concluded that the term "health care economic information" should include all forms of economic analysis so the guidance could adapt to new and evolving outcomes research methods.
One of the phrases in Section 114 that is difficult to interpret is that promotion must involve a claim that "directly relates to an indication approved [by the FDA]." In the draft guidance, PhRMA proposed that extrapolation from data included on labeling would be appropriate at least under the following circumstances: from duration of use in labeling to actual duration of use found in pharmacy databases, from dosages included in labeling to actual dosages found in pharmacy databases, and from controlled trial settings to actual practice settings.
The standard set by Section 114, "competent and reliable scientific evidence," is the same standard used by the Federal Trade Commission (FTC) when assessing the adequacy of substantiation for manufacturer claims involving OTC drugs and products affecting environmental health. That standard requires transparency of methods and use of methods accepted by experts in the field. In its proposal, PhRMA recommended that the FDA follow long-established FTC interpretation of the competent and reliable scientific evidence standard.
The full FR Notice on "Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments" can be found here.
In October 2012, PhRMA issued a white paper, asking the FDA for guidance on the supporting evidence drug companies need for the health care economic data they send to formulary managers should specifically allow for use of a range of data sources, not limited to adequate and well-controlled clinical trials.
The white paper urges the agency to develop formal regulatory guidance on Sec. 114 of the FDA Modernization Act of 1997, which allows drug companies to proactively disseminate health care economic information to formulary committees within certain limitations.
The white paper outlines a number of data elements that should satisfy the competent and reliable scientific evidence standard. They include: methods for establishing economic costs and consequences that are widely accepted by experts in the field using a clear, pre-defined study protocol; an “accurate and balanced assessment of the economic consequences of a drug therapy, consistent with the current weight of credible evidence”; a representative study population; and information that allows the reader to determine how the research was conducted.
PhRMA recommends that FDA allow the competent and reliable standard to be satisfied with data obtained through a number of different methods, including observational study designs, database reviews and other economic modeling techniques. “There should be no pre-specified number or type of study required to substantiate a claim."
For example, “a claim that a drug is more cost-effective than a competing drug may be made where the cost savings are due to reduced resource utilization resulting from improved efficacy outcomes, decreased administration or monitoring costs, or where the difference in cost is due to the drug causing fewer adverse events, as long as these differences are supported by competent and reliable evidence.”
PhRMA argues that FDA should not consider such a statement a comparative clinical claim, which would trigger the “substantial evidence” requirement involving clinical trials.
Companies should be permitted to disseminate data on the “real world” economic implications of a therapy on health outcomes, according to the white paper. For example, “if a manufacturer conducts a competent and reliable study investigating the impact of a drug indicated for the treatment of diabetes mellitus on costs associated with cardiovascular care, the manufacturer should be permitted to proactively disseminate such data to appropriate audiences.”
Tom Abrams’ comments should act as more than a passing notice. Folks – it’s time to step up to the plate – the implications for payers and academic detailing are both timely and significant.
From that well-know Tea Party mouthpiece – the Associated Press …
FACT CHECK: Obama spins health insurance rebates
WASHINGTON (AP) - Another year, another round of exaggeration from President Barack Obama and his administration about health insurance rebates.
In his speech defending his health care law Thursday, Obama said rebates averaging $100 are coming from insurance companies to 8.5 million Americans. In fact, most of the money is going straight to employers who provide health insurance, not to their workers, who benefit indirectly.
Obama danced around that reality in remarks that also blamed problems in establishing affordable insurance markets on political opponents, glossing over complex obstacles also faced in states that support the law.
A look at some of his claims and how they compare with the facts:
-"Last year, millions of Americans opened letters from their insurance companies. But instead of the usual dread that comes from getting a bill, they were pleasantly surprised with a check. In 2012, 13 million rebates went out, in all 50 states. Another 8.5 (million) rebates are being sent out this summer, averaging around 100 bucks each."
- After introducing several people who got rebate checks last year: "And this is happening all across the country. And it's happening because of the Affordable Care Act. Hasn't been reported on a lot. I bet if you took a poll, most folks wouldn't know when that check comes in that this was because of Obamacare that they got this extra money in their pockets. But that's what's happening."
-" If they're (insurers) not spending your premium dollars on your health care - at least 80 percent of it - they've got to give you some money back."
THE FACTS: Just as he did a year ago, Obama made a splashy announcement about rebates that incorporates misleading advertising.
The health care law requires insurance companies that spend too much on administrative expenses to issue rebates to customers. But those customers are often employers that in turn offer insurance to workers and bear the bulk of the costs. In workplace plans, the rebate goes to the employer, which must use it for the company health plan but does not have to pass all or part of it on to the worker. People who buy their own insurance and qualify for a rebate get it directly.
Obama was on solid ground in saying "millions of Americans" got rebate checks last year, but the number was not close to 13 million as he implied.
Of the 12.8 million rebates announced last year, health policy experts estimated 3 million would go directly to the insured. The government didn't know how many.
Nearly two-thirds of the 12.8 million were only entitled to pro-rated and decidedly modest rebates, because they were covered by employers that pay most of their premiums. Workers typically pay about 20 percent of the premium for single coverage, 30 percent for a family plan. Employers pay the rest.
And employers can use all the rebate money, including the workers' share, to benefit the company health plan, perhaps restraining premiums a bit or otherwise improving the bottom line. The law requires insurers to spend at least 80 percent of premiums they collect on medical care and quality improvement, or return the difference to consumers and employers.
Altogether, this year's rebates are worth $500 million, down from $1.1 billion returned last year. The government says the lower rebates mean insurance companies are becoming more efficient.
-"I'm curious, what do opponents of this law think the folks here today should do with the money they were reimbursed? Should they send it back to the insurance companies?"
THE FACTS: Even in that unlikely event, most people could not send it back to insurance companies because the money doesn't go "in their pockets" and they have no control over what their employers do with it.
-"In states that are working hard to make sure this law delivers for their people, what we're seeing is that consumers are getting a hint of how much money they're potentially going to save because of this law. In states like California, Oregon, Washington, new competition, new choices, market forces are pushing costs down."
THE FACTS: It is simply not known whether health insurance will become less expensive in those states - or nationally than it is now, or than it would have been absent the law. And hitches in setting up the new insurance marketplaces called exchanges are not limited to Republican-led states where leaders object to the law, although that political pushback is certainly part of what's going on.
In California, for example, where there is plenty of competition by health insurers wanting to get into the exchange, an actuarial report commissioned by Covered California, the state agency running the insurance marketplace, found that middle-income residents could see individual health premiums increase by an average of 30 percent while costs go down for lower income people.
In West Virginia, Democratic Gov. Earl Ray Tomblin - also a cooperative partner in expanding Medicaid and setting up an exchange - complained to federal officials this week about delays in rules and guidelines from Washington as the state struggles to meet deadlines under the law.
"Many West Virginia families have expressed frustration" trying to find out how much policies from the exchange will cost them and whether they will get a subsidy, he said, and the state is "dangerously close" to falling short of requirements under the law.
Read More & Comment...In case you had any doubt that Indian policy on pharmaceuticals isn’t predicated on domestic manufacturing policy …
A day after a high-level panel headed by Prime Minister Manmohan Singh relaxed foreign direct investment (FDI) norms in sectors ranging from telecom to single brand retail, he’ll be holding a separate meeting to review the policy in the pharmaceutical sector.
According to a senior official, "The main concern of the Ministry of Commerce and Industry is that a stage might come when India might not have a company ready to manufacture drugs on behalf of the government, even if the provision of compulsory license is invoked.”
Shouldn’t the fact that acquiring companies are paying huge valuations -- many time the cost of setting up new projects -- raise a question as to their motivation – and that of the Indian government?
Read More & Comment...Another example of domestic manufacturing policy trumping the public health?
It took only two months after patent expiry in China for two generic versions of Novartis AG’s blockbuster chronic myeloid leukemia drug Glivec (imatinib) (marketed as Gleevec in the U.S.) to gain China FDA approval, and many more are expected to follow suit. But Novartis plans to fight back by highlighting the quality and efficacy of its brand and its long-running patient assistance program.
Two companies received CFDA approval June 26, Jiangsu Hansoh Pharmaceutical Co. Ltd. and Jiangsu Chia-tai Tianqing Pharmaceutical Co. Ltd., or CTTQ, 60% of which is held by Hong Kong-listed Sino Biopharmaceutical Ltd. CTTQ holds the first capsule generic approval, while Hansoh received CFDA approval for a tablet formulation of imatinib. Generic imatinib for chronic myeloid leukemia will launch in August, Sino Biopharmaceutical said during a July 4 event.
Although the Glivec compound patent expired in China in April, Novartis still holds a beta crystalline patent in the country until 2018 and a patent for a gastrointestinal stromal tumors indication until 2021, Novartis China said. According to Novartis, the two China generics are likely alpha crystalline forms of imatinib.
“The generic has a different crystal type, so the product quality and treatment result will be totally different,” said Wendy Wang, head of communications for Novartis Oncology China.
The imatinib generics race is just warming up. According to CFDA’s database, as of July 16, there were 16 new applications for imatinib generics in 2013, including an imported drug application.
Read More & Comment...For those of you following the recent CMS decision to deny coverage for contrast-enhanced PET scans ("Taking CMS to the Wood CED"), BioCentury’s Steve Usdin offers a timely and granular peek into the related world of laboratory-developed molecular diagnostics, detailing the cost, time and risk required to get these basic tools of personalized medicine onto the market -- and the decreasing the certainty that they will be covered.
Some snippets:
The cost of demonstrating clinical utility, along with the lack of clear or consistent standards, is killing a business model that had made it possible for small companies to commercialize molecular diagnostics quickly and cheaply.
The fate of these laboratory-developed molecular diagnostics companies, and especially the conclusions investors draw about the viability of the space, could shape the future of personalized medicine.
Labs have been sparring with FDA for at least a decade over the agency’s attempts to regulate LDTs, and so far they’ve kept the regulators at bay. FDA Commissioner Margaret Hamburg opened the latest front at the American
Society of Clinical Oncology meeting in June, when she announced the agency plans to eliminate the regulatory distinction between LDTs and in vitro diagnostics marketed to multiple labs or physicians that have long been subject to premarket review.
The agency has developed a draft guidance that would “regulate all in vitro diagnostic tests in the same risk-based framework the agency currently uses, whether or not they are performed by a single laboratory.”
While FDA will find it difficult to use guidance documents or rules to impose clinical utility requirements on LDTs, payers have found a more prosaic tool for achieving the same goal: billing codes.
The full BioCentury article, “Coding for Utility,” can be found here.
Read More & Comment...
Why is it that, when the pharma industry does things right, the story goes unreported in the mainstream media?
That’s a rhetorical question.
Here’s the good news:
Per a new study by Johns Hopkins University (and supported by AHRQ), FDA requirements for postmarket data on new prescription drug approvals have raised the number of postmarket studies completed and reduced the number of uninitiated studies by manufacturers.
Following the passage of the Food and Drug Administration Amendments Act (FDAAA) in 2007, the number of completed studies that fulfilled postmarket obligations nearly doubled from 6.6% in 2007 to 12.6% in 2011.
Among studies not yet initiated by the manufacturer, there was an opposite trend over the study time period, with 56.7% studies not started in 2007 and 43.5% not yet started in 2011, they wrote in a research letter online in the Journal of the American Medical Association.
"Our analysis found the number of studies not yet started declined during this 5-year period, and the number of studies fulfilling obligations nearly doubled," the authors pointed out.
Prior to 2007, drug manufacturers completed postmarket safety trials on a voluntary basis. The passage of the FDAAA authorized the agency to require manufacturers to submit postmarket data as part of the prescription drug approvals process, as well as holding manufacturers to deadlines.
Many rare, but potentially serious adverse events are only found after a drug receives FDA approval, the authors noted.
The study reviewed changes in fulfillment of postmarket studies following the passage of the FDAAA from 2007 to 2011 through a review of all postmarket study status data for both biological and new drug applications.
Studies were categorized as pending, ongoing, delayed, terminated, submitted, released, and fulfilled.
The total number of postmarketing studies in each year in the study period was greater than the number required under the act:
- 1,841 versus 0 required in 2007
- 1,901 versus 46 in 2008
- 2,227 versus 153 in 2009
- 1,774 versus 279 in 2010
- 1,781 versus 387 in 2011
The authors noted three trends over that time: the number of studies not yet started decreased, completed studies that met postmarket requirements increased, and delayed studies also increased. The number of studies not yet started fell from 1,044 (56.7% of all studies) in 2007 to 775 (43.5%) in 2011. Completed studies rose from 122 (6.6%) in 2007 to 224 (12.6%) in 2011. Delayed studies rose from 125 (6.8%) in 2007 to 241 (13.5%) in 2011.
Over the study period, the number of ongoing studies, studies submitted for FDA evaluation, and terminated studies remained relatively constant.
"These trends help address concerns expressed by the Institute of Medicine that many postmarketing studies before the FDAAA were not implemented or fulfilled," they wrote, cautioning that in spite of improvements, "more than 40% of studies had not yet been started in 2011," while the number of studies that were delayed doubled over the study period to "approximately one in eight."
The authors also noted that their research was limited by a design that did not statistically isolate the legislation's effect on fulfillment rates, and a lack of examination of content and outcomes of postmarketing studies.
Read More & Comment...From the pages of Drug Industry Daily …
China Investigating Drug Pricing At Domestic, Multinational Firms
The Chinese government is conducting a review of drug pricing and manufacturing costs at selected domestic and international companies, with an eye on making healthcare more accessible to its people.
The review, by the National Development and Reform Commission (NDRC), will look at drugmakers’ data from 2010 through 2012, including corporate audit reports, sales agreements and shipping records. Importers will also be asked to provide information about border control costs such as customs clearance, quarantine fees and storage fees, a July 2 NDRC notice says.
According to Citi Investment Research analyst Richard Yeh, the inquiry will target about 60 drugmakers — including GlaxoSmithKline, Boehringer Ingelheim, Fresenius Kabi and Sandoz — and focus on prices of drugs recently added to the 2013 essential medicines list and preferentially priced branded generics from multinationals.
“Our checks also suggest that the survey may not necessarily lead to price cuts on the surveyed drugs or imply another round of price cuts, but likely reflects the NDRC’s intention to build a more optimized drug pricing regulation system and to provide a basis for future price cuts” on exorbitantly priced drugs, Yeh writes in a research note.
Helen Chen, head of L.E.K. Consulting’s China life sciences practice, said the exercise could be useful if the NDRC’s aim is to educate itself about the cost of providing quality drugs.
“The key issue here, though, is whether they understand the cost of drug quality goes beyond the simple manufacturing [cost of goods sold],” Chen said. “I hope NDRC’s intention is not just tallying ex-factory price and mandate [sic] a small allowable markup as they had proposed for device manufacturers.”
Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, also sounded a note of skepticism. “It’s important for Beijing to understand and appreciate that lower cost does not necessarily lead to broader patient access,” he told DID Wednesday. “For example, the 100 top drugs on the World Health Organization’s essential drug list are all off-patent and yet there is still little or no access to them in China.”
Also of concern, Pitts added, is that the national government’s control over manufacturing issues in the provinces has proven to be spotty, despite recent regulatory advances at the ministry level.
The survey comes amid an ongoing effort by China to “establish a healthcare system covering urban and rural residents, and to provide safe, effective, convenient and affordable medical service,” as explained by then-President Hu Jintao in 2007.
Chen noted that, in the early 2000s, the government had to force 10 large drugmakers to produce a list of basic medicines that companies had stopped making because the prices were too low to be profitable. According to Yeh, the NDRC released a guideline for drug ex-factory price surveys in November 2011 and began creating a mandatory ex-factory drug price reporting system in September of last year.
Pfizer has received European approval to expand the use of its pneumococcal conjugate vaccine Prevenar 13 to adults aged 18 to 49 years for the prevention of invasive pneumococcal disease, according to a company statement.
The vaccine, which protects against 13 strains of Streptococcus pneumoniae, is approved in the European Union (EU), the United States, and elsewhere for use in infants, young children, and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older.
"Prevenar 13 is now the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood." the company said in the statement.
The European Commission's decision to expand use of the vaccine to 18- to 49-year-olds followed the submission and review of data from an open-label phase 3 trial of the vaccine in healthy adults in this age group, the company said.
The study, which met all primary and secondary objectives, showed that the vaccine is at least as immunogenic in this age group as it is in adults aged 60 to 64 years, as measured 1 month after vaccination. Prevenar 13 showed a favorable safety profile and was generally well-tolerated.
"Adults aged 18 to 49 years with certain underlying medical conditions may benefit in particular from vaccination with Prevenar 13 because of an increased risk of pneumococcal disease," said Luis Jodar, PhD, vice president of the Vaccines Global Medicines Development Group at Pfizer.
Prevenar 13 (known as Prevnar 13 in the United States, Canada, and Taiwan) is now approved in more than 120 countries worldwide for use in infants and young children, as well as in more than 80 countries for use in adults 50 years of age and older.
But not approved for scheduling in the United States (beyond patients who are immunocompromised or over age 65). What’s wrong with this picture?
On the last working day of the year (December 30, 2011), the FDA approved Prevnar 13 (a pneumococcal 13-valent conjugate vaccine) for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. In fact, the new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.
(The Centers for Disease Control and Prevention reports that 5,000 adults die from pneumonia every year.)
And to drive home the importance of this action, the FDA issued a press statement on the approval before heading home for the long weekend:
“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Not so fast.
Although it’s quite a high hurdle to have a vaccine approved by the FDA (and appropriately so), it’s not the final hurdle in getting it to patients. That final hurdle resides with the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).
ACIP’s charge is to “provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population.”
The ACIP meets three times a year, and during these meetings newly licensed vaccines are discussed and a vote is taken to include (or not include) the new vaccine on the adult immunization schedule. ACIP’s recommendations become a basis for reimbursement by public and private payers who will pay for vaccinations that are part of the committee’s recommendation -- but generally not otherwise. The CDC schedule plays an important gatekeeper role for vaccines that goes well beyond the scope of FDA approval. Vaccines approved by the FDA but not appearing on the CDC routine vaccination schedule are likely to gain little traction because of a lack of guidance to providers on how to use the vaccine -- and lack of payer coverage.
In other words, minus a positive ACIP recommendation, a disease that is responsible for approximately 200,000 emergency room visits a year will continue to harass patients and haunt our healthcare system. Minus a positive ACIP vote, new and potentially life-saving vaccines are redlined and another nail is hammered into the coffin of innovation.
The need for this patient population exists. The vaccine is safe and effective. Without a recommendation the vaccine will not be available to a large swath of Americans. It’s time for ACIP to call the question.
The battle against the “dangerous idiots” of vaccine denial is dangerous enough, we must avoid the equally daunting danger of … inertia Read More & Comment...
"It is not from the benevolence of the butcher, the brewer, or the baker that we expect our dinner, but from their regard to their own interest." - Adam Smith
Good reporting from MedPage Today – demonstrating once again that, when it comes to lowering healthcare costs and improving healthcare outcomes, the free market trumps Big Government.
More Choice More Common in Medicaid Plans
States are increasingly moving to privatized managed care programs for their Medicaid recipients as state lawmakers look to change the safety-net system despite objections from naysayers, members of Congress were told Monday.
Kansas, Louisiana, and, most recently, Florida have received federal OKs to offer expanded managed care programs that allow patients to choose from a list of plans with varying benefits.
"The states set the floor of the benefits on those plans, but then the plans can add additional benefits on top of that using the savings they create by better coordinating care," Tarren Bragdon, chief executive of Foundation for Government Accountability, a conservative think tank in Naples, Fla, said after a House Energy and Commerce Health Subcommittee hearing Monday examining Medicaid.
Privatized plans include traditional Medicaid managed care programs and provider-driven plans. Florida, which had its federal waiver approved last month, offered 13 plans and 31 benefit packages in its five-county pilot program, Bragdon said.
"Patients like this choice, with 70% to 80% of Medicaid patients proactively choosing the plan rather than being automatically assigned to one," Bragdon told lawmakers.
States spend between a quarter and a third of their budgets on Medicaid, surpassing the amount spent on education, and they can expect that amount to grow under the Affordable Care Act's expansion program, which opens the program up to all those making up to 138% of the federal poverty level.
States like Florida, Louisiana, and Kansas can expect to save money, Bragdon said, making states like North Carolina, Texas, and Utah consider similar moves. The states believe they can generate greater savings through managed care for more expensive patient groups like the elderly and disabled.
The plans have risk-adjusted capitated rates so they earn more money to enroll sicker patients and have incentives to improve patients' health, Bragdon said. Competing for enrollment, plans are forced to improve benefit packages and improve access to specialists. Plans must publicly report outcomes and conduct consumer-satisfaction surveys annually.
In Louisiana, patients have the choice to opt back to traditional Medicaid. But of 900,000 Medicaid patients, only 3,000 took that option.
"The Florida reform pilot outperformed on health outcomes in 64% of the cases," Bragdon said.
But opponents of privatizing Medicaid cite a lack of accountability over the plans.
"The pilot program for Medicaid privatization [in Florida] was known as a real disaster," Rep. Kathy Castor (D-Fla.) said during Monday's hearing. "The state's own study condemned the results."
Several plans dropped out of the pilot citing an inability to make money, and patients complained of bouncing from plan to plan creating lapses in care.
She called the final waiver approved for the state-wide program "night and day" different from the pilot. The statewide program has new consumer protections, penalties for providers who back out, and medical loss ratios, Castor said.
"While these programs have been controversial in some instances, they reflect a desire by states to utilize care coordination and care management methods and move away from Medicaid's fee-for-service history," Alan Weil, executive director of the National Academy for State Health Policy in Portland, Maine, told lawmakers.
All but three states have at least some Medicaid managed care in their state, and Weil said two-thirds of Medicaid patients receive most or all of their benefits through managed care.
"States are increasingly relying on mandatory managed care programs in Medicaid for more complex populations such as children with special healthcare needs and people of all ages with a variety of healthcare needs," Weil said.
Read More & Comment...The lack of clinically useful diagnostics is hindering the growth of personalized medicine.
According to research by the Tufts Center for the Study of Drug Development, without clinically useful diagnostics, personalized medicine growth will occur at a relatively slow pace.
And personalized medicine represents the future of healthcare around the world.
That’s why the recent CMS decision to deny coverage for contrast-enhanced PET scans is a disturbing harbinger of the continued battle between short-term cost concerns on the one side and long-term patient care and medical innovation on the other.
CMS released a draft decision memo indicating that Medicare would pay for contrast-enhanced PET scans aimed at visualizing beta-amyloid protein plaques in patients brains only in the context of rigorous clinical trials, under the agency's "coverage with evidence development" (CED) policy.
The Alzheimer's Association said it was "disappointed" by the government's tentative decision last week not to allow broad Medicare coverage for brain amyloid imaging.
"With 5 million Americans living with Alzheimer's and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical," the group said in a statement.
The Alzheimer's Association noted that, in the past, it has taken as long as 7 years for CMS to move from a CED designation for new medical technologies to full coverage.
"The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer's field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer's epidemic," the group's statement said.
Eli Lilly & Co., which sells the only currently approved PET contrast agent (AmyVid), said it was disappointed in the CMS's draft decision memo, as did the Medical Imaging and Technology Alliance.
All three organizations pointed to "appropriate use criteria" published earlier this year by an expert panel that backed clinical use of the technology in select patient groups.
The panel, convened by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging, said PET amyloid scans would be appropriate for patients with unexplained cognitive impairments, those with tentative Alzheimer's disease diagnoses who show unusual clinical presentations, and those with progressive dementia occurring before age 65.
The Alzheimer Association and Lilly noted that the memo is currently open for public comment (through August 2) and that CMS could still decide to allow broader coverage.
Let’s cut to the chase, if we are going to take meaningful strides both in addressing Alzheimer’s Disease specifically and in personalized medicine more broadly, we should not rely on Coverage with Evidence Development (CED) criteria in cases where the FDA’s approval process has expressly evaluated and endorsed the use of a drug or biologic in a specific patient population.
Fact: The evidence on amyloid imaging supports coverage for the population as identified by the Amyloid Imaging Task Force through Appropriate Use Criteria (AUC). A task force, convened by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, recommends coverage in this population based on a comprehensive review of the literature and expert consensus.
Fact: CMS currently covers similar PET technologies to aid in the diagnosis of Alzheimer’s Disease and other forms of cognitive decline. The agency has not previously required evidence of health outcome improvement as a condition of such coverage.
Fact: Using CED alone will deny Medicare beneficiaries adequate and rapid access to this technology, as the path to implementation is unclear. Such uncertainty in the reimbursement process strongly dis-incentivizes future investments in research and development. And without innovation there will not be advances in personalized medicine.
Wither “sustainable innovation?”
Why even bother with expedited review and similar FDA pathways? Clearly closer FDA/CMS coordination is required to address both the will of Congress – and the future of American healthcare.
What's on your list of FDA spending priorities? According to report in the Pink Sheet, the Wizards of White Oak are currently spending just south of $10,000,000 on 11 research projects -- including a $2 million study of online prescription drug promotion.
According to OPDP panjandrum Tom Abrams, “Our objective as an agency is to increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions.”
First let’s look at the record.
OPDP receives 6,000 to 8,000 advertising and promotional submissions each month, which are assigned to one of OPDP’s 32 reviewers. Per Tom Abrams, the office gets about 120 complaints about promotional materials each year from physicians, consumers and pharmaceutical companies, and of these about 45 concern DTC ads. In 2012, OPDP issued 10 untitled and warning letters for DTC promotions.
Are 10 letters worth $10,000,000 in sparse agency resources? Well, where you stand depends on where you sit.
In the view of Jeff Francer, PhRMA’s assistant general counsel, research activity is taking place “when many stakeholders are asking for regulatory guidance.” There is a “question as to how OPDP is spending its resources.”
As for the value of FDA’s DTC ad research, Francer said it is unclear to him what benefit it provides.
That’s a fair question. If, as Tom Abrams said, the objective of the studies (and hence the justification for the spending) is to “increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions,” then why isn’t the agency working with industry (where the expertise and experience resides) rather than going it alone? If the goal is to increase compliance, then why research rather than better guidance (per Francer)?
Tom Abrams equates “increased quality” with accurate, non-misleading information. And that’s important. But it’s the second part of his definition that should provide a pause for reflection. Consider, “ … instead provide patients with good information about prescription drugs and medical conditions.” Many (if not all) companies that advertise prescription drugs would (and should) argue that their advertisements do precisely that.
Can industry do better? Yes. Should they do better? Yes. Will these OPDP studies help them do better? That’s the question on the table – and it’s an open one.
At the end of the day, “in compliance” and “in the best interests of the public health” must not be mutually exclusive – indeed they should me mutually supportive.
Where will the FDA’s 10,000,000 take us? Will they be a turning point, resulting in pharmaceutical companies’ embracing an educational public health imperative and allotting more media dollars for help-seeking advertising? Or will they be a tipping point, with politicians and the public zeroing in on aggressively targeted DTC in print, on TV … and online?
Working together with industry, FDA can make a difference. Together, industry and FDA can evolve DTC communications into a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality—because “an educated consumer is our best customer.”
FDA DTC Advertising Research Projects Underway |
||
Project |
Cost |
Objective |
Quantitative Effectiveness Information in Television and Print Advertisements |
$1,026,555 |
Examine whether adding placebo information and whether changing the framing of the information helps consumers understand risk information. Also examine how physicians use the prescribing information documents and assess efficacy information. |
Composite Scores |
$356,082 |
Determine whether consumers understand composite scores (overall score of drug’s affect on multiple symptoms) as currently communicated and how best to communicate these scores to lay audiences.
|
Disease Information in Branded Promotional Material |
$1,500,000 |
Investigate the effects of adding disease information to promotional materials on consumer perceptions and understanding. |
Effect of Promotional Offers in Print Advertisements on Consumer Product Perceptions |
$924,365 |
Examine what impact, if any, the presence of coupons in DTC ads may have on consumers’ recall and perceptions of product risks and benefits, and the overall impression of the product in full-product and reminder ads. |
Comparative Advertising |
$1,482,034 |
Determine how consumers interpret and react to DTC comparative drug ads. |
Corrective Television Advertising |
$386,286 |
Evaluate how corrective DTC Rx drug advertisements impact consumer perceptions |
Online Promotion |
$2,019,620 |
Test different ways of presenting Rx drug risk and benefit information on branded drug websites. |
Brief Summary Format Variations in Print Advertisements |
$296,509 |
Determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary. |
Healthcare Professional Survey |
$364,588 |
Follow-up to 2002 physician survey, it is designed to explore the opinions and perceptions of physicians, physician assistants and nurse practitioners regarding promotion of Rx drugs to consumers and health care providers. |
Patient Information Prototypes |
$1,613,294 |
Test two different formats for presenting patient medication information to patients when they retrieve their prescriptions. |
Risk and Benefit Perception Scale Development Focus Groups |
Not Available |
Develop and validate risk and benefit perception scales and explore various methods for measuring recall and comprehension. |
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