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The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study found that metformin and Avandia were superior to other treatments in controlling the disease in kids.
I have two questions: Will Steve Nissen admit he was wrong, again? Also, will doctors start to use existing diagnostics that identify those who do not respond to metformin, at least in kids. Isn't that choosing wisely?
Patient, diagnose thyself -- and then reach a little deeper into your wallet.
Physician, step aside.
Pharmacist, step up to the plate.
Maybe.
The FDA may soon permit Americans to obtain some drugs used to treat conditions such as high blood pressure and diabetes without obtaining a prescription.
The FDA says over-the-counter distribution would let patients get drugs for many common conditions without the time and expense of visiting a doctor, but medical providers call the change medically unsound and note that it also may mean that
Under the changes that the agency is considering, patients could diagnose their ailments by answering questions online or at a pharmacy kiosk in order to buy current prescription-only drugs for conditions such as high cholesterol, certain infections, migraine headaches, asthma or allergies.
By removing the prescription requirement from popular drugs, the Obama administration could ease financial pressures on the overburdened Medicare system by paying for fewer doctor visits and possibly opening the door to make seniors pay a larger share of the cost of their medications.
The change could have mixed results for non-Medicare patients. Although they may not have to visit a doctor as often, they could have to pay out more money for medications because most insurance companies don't cover over-the-counter drugs.
How will this impact patient compliance? How will this effect one condition masking another, more serious one?
How will this change the role of the pharmacist?
Comments on the FDA proposal are due by May 7.
“Cozy Deal” (New York Times, April, 29, 2012) argues,
“The best approach would be for the government to fully finance the F.D.A. That is unlikely to happen. So before it ratifies any new deal on user fees, Congress must ensure that patient safety is the first priority.”
Sure, but unlike the Gray Lady we must all live in the real world. User fees are the cost of predictability -- not just for innovators who wants to know if and when they can commence marking new products but also for patients and physicians who want to know if and when these new treatments will be available. Predictability is also an issue of how. And this rests on the ability of the FDA to create and communicate a thoughtful and patient-centered model of risk/benefit analysis. Thankfully this is a central part of the current reauthorization debate.
Talk about positive outcomes!
It pays to have friends on PCORI’s Methodology Committee. Five of the seven grantees selected for PCORI funding are directly affiliated with members of that panel. In dollar terms its even more lopsided. Of the $799,524 awarded, $721,940 went to institutions with direct representation on the conclave.
If those committee seats are pro bono somebody should ask -- Cui bono?
Today is Yom Haatzmaut (Israel Independence Day) and Peter Beinart will be celebrating it by giving a lecture at a synagogue about his anti-Israel book, “The Crisis of Zionism.” In doing so, Beinart joins Gunter Grass and the producers of the 60 Minutes segment (blaming Israel for the withering away of the Palestinian Christian community) in proposing that Israel can only be purified if it ceases to exist as a Jewish state.
Victor Davis Hanson points out that the new anti-Semitism regards the creation of the Jewish state as a manifestation of the Western hegemonic impulse. It barely concedes that Israel is democratic and protects human rights in a way unlike its autocratic neighbors. It’s proponents ignore the systematic persecution of Christians in Arab countries, the torture and extortion of Hamas, the ongoing slaughter in Syria, the resurgence of the Islamic Brotherhood.
Rather, they are focused on forcing Israel to give up what the Economist calls the “Auschwitz Complex.” accrued from the Holocaust, a pathology which they say its unwillingness to “to give up its empire” (by crawling back into the 1949 borders of the state and absorbing millions of Palestinians).
The remembrance of the Holocaust is a searing reminder of the necessity of Israel. Yom Hashoah is recalled by a two minute siren -- invoking the shofar – that turns all moving things and people into standing monuments.. The moment stretches on, the wail growing tighter and thinner, like a taut thread, binding all together, until it unwinds.
But Yom Ha-Shoah is only the tragic beginning of the story, not the end. Seven days after, Yom Ha’atzmuat (Israel Independence Day) is celebrated. The day preceding that holiday, Israel observes Yom Ha-Zikaron ( Memorial Day) to reaffirm (as written in the Israel Defense Force manual) “that establishing the State of Israel was intended to provide an answer to the problem of the existence of the Jewish people, in view of the fact that all other solutions had failed. The Holocaust proved, in all its horror, that in the twentieth century, the survival of Jews is not assured as long as they are not masters of their fate and as long as they do not have the power to defend their survival.”
The movement from Yom Hashoah, to Yom Ha-Zikaron to Yom Ha'atzmaut reminds people, as Rabbi Irving Greenberg notes, that the “ State of Israel is not a reward or a product or an exchange for the Holocaust; it is a response. The Jewish people responded to the total assault of death by an incredible outpouring of life.”
And with an enduring sense of purpose. When my son immigrated to Israel in 2007 and joined the IDF he was repeatedly asked why he did so. He could never fully explain to others or to himself until his unit was called into battle during 2008 Operation Cast Lead against Hamas.
He was in an APC with his brothers in arms. He looked around at his comrades with who he shared the cramped space.
Zach writes:
“To my right was the sharpshooter, an Ethiopian by the name of Redit Mullah. His parents were thrown onto Israeli chartered planes and saved from political instability and war in the 1991 Solomon Operation, when Israel rescued and integrated thousands of Ethiopian Jews into its growing populace.
To my left was my friend Avichai Galilee, of Yemenite descent, whose grandparents were similarly rescued from persecution and vehement Arab violence by a massive and unprecedented Air-Evac operation known as ‘Operation Magic Carpet’ in 1950.
In back of me were two soldiers, of Russian and Iraqi descent. They both shared the same legacy of being rescued and welcomed by the Jewish state when they had no place else to live as Jews. It did not matter that the Israeli economy was anemic at the time and that we had few resources to spare. We did it anyways.
It then finally made sense to me: The state of Israel is there for us, and so should we be there for the state of Israel. Riding away in our APC’s it was us who was thanking Israel and paying a debt of gratitude for all it had done for us. “
Tomorrow Israel celebrates this spirit. So do most Americans, who know that a democracy can achieve great things only if the citizens believe it is worth defending. Only people like Beinart want to strip the Jewish state of this eternal essence.
The study group, METABRIC (Molecular Taxonomy of Breast Cancer International Consortium), reports its findings in the 18 April online issue of Nature. The Cancer Research UK-funded study is the largest global gene study of breast cancer tissue ever conducted, involving a large team of researchers, primarily in the UK and Canada.
Led by Professor Carlos Caldas from Cancer Research UK's Cambridge Research Institute and Professor Sam Aparicio from the British Columbia Cancer Centre in Canada, the team uncovered crucial new information about breast cancer. The researchers analyzed the DNA and RNA of breast tumor samples from nearly 2,000 women who had been diagnosed between five and 10 years ago, and for whom information about the tumor characteristics had been meticulously recorded. They compared this with the women's survival, and other information, like their age at diagnosis. Because the study was able to look at many tumors with rich data on each, it identified new patterns and "clusters" in the data not spotted before. In the study, the team classified breast cancer into at least 10 different subtypes: each characterized by common genetic features that link to survival. This suggests we need to rethink what we call breast cancer and start looking at it as at least 10 different diseases, each with its own molecular fingerprint and pattern of weak spots.
Dr Harpal Kumar, chief executive of Cancer Research UK, told the press the study will completely change the way we look at breast cancer. Caldas, who is also Professor of Cancer Medicine at Cambridge's Department of Oncology, said "breast cancer" should be regarded as an umbrella term for a range of diseases. The findings could change the way drugs are tailored to treat individual women with breast cancer. The team also discovered several previously unknown genes that drive breast cancer. Each of these is a potential target for new drugs, and should boost worldwide efforts to discover and develop new treatments. The study also reveals the relationship between these breast cancer genes and known signalling pathways, the networks that control cell growth and division. This invaluable knowledge will help identify how variants of these genes cause cancer by interfering with cell processes.
Over decades, the METABRIC project has produced a "goldmine" of data, says Caldas. The process is not unlike that of cartography. At first, intrepid explorers discover new continents, defined by outlines and some rough impressions of terrains and landscapes. Then gradually, as mapping techniques improve, the data becomes more detailed and more precise. The METABRIC team now has a detailed "map" of thousands of individual tumors that have been analyzed and re-analyzed in many different ways and linked to detailed information about the fate of the women they came from.
Not only has the team performed all kinds of analysis on the DNA of the tumors (for instance the map is now annotated with copy number changes and single letter variations or SNPs, for each tumor), it has also conducted a detailed analysis of their RNA so they can tell which genes were active in each sample. Altogether they did this for more than 30,000 types of RNA, each corresponding to the activity of a single gene. "We've drilled down into the fundamental detail of the biological causes of breast cancer," said Caldas, "we've moved from knowing what a breast tumour looks like under a microscope to pinpointing its molecular anatomy". "Our results will pave the way for doctors in the future to diagnose the type of breast cancer a woman has, the types of drugs that will work, and those that won't, in a much more precise way than is currently possible," he added.
Aparicio said: "The new molecular map of breast cancer points us to new drug targets for treating breast cancer and also defines the groups of patients who would benefit most." Caldas said these results will not affect women diagnosed with breast cancer today, but he envisages future breast cancer patients will receive treatments tailored specifically to the genetic fingerprints of their tumors. From this huge leap forward, the next step is to find out how the tumors in each of subgroup behave.
Caldas had this to say to the patients behind the study: "I want to stress, this study wouldn't have been possible without the breast cancer patients who donated their samples and agreed to take part in the study. None of this would have happened without them, and I'm so grateful for their participation." For an excellent account of how we have increased our understanding of breast cancer, plus a table showing the 10 disease subtypes, see Henry Scowcroft's post in the Cancer Research UK Science Update blog.
Transparency (via social media) is leading to erosion in trust of once sacrosanct gurus such as physicians, corporations, their avatars and other “experts” (not the least of which is the mainstream media).
It’s been a painful and swift denuding of influence. Rather than being slowly disrobed, yesterday’s unquestioned experts have been roughly stripped of their gravitas and authority. Some have behaved badly, the majority has ignored it. Too few have gotten the message – adapt or die. You can’t airbrush social media.
Perhaps (and hopefully) this isn’t so much a downward spiral as it is (in the words of Schumpeter) “creative destruction.”
As Schumpeter writes in Capitalism, Socialism and Democracy, “The fundamental impulse that sets and keeps the capitalist engine in motion comes from the new consumers, goods, the new methods of production or transportation, the new markets, the new forms of industrial organization that capitalist enterprise creates.”
He would have loved social media.
While various “emperors” are being exposed as having no clothes, the void is being filled with robust and real-time peer-to-peer communications. Alas, there are also many ascendant false prophets. The Internet is full of them. Some are well-meaning (but still dangerous) idiots (such as the anti-vaccine crowd), others pure charlatans ("Cure your cancer in Mexico!").
As Don Draper once said, “I'm enjoying the story so far, but I have a feeling it’s not going to end well.”
Social media is a wonderful “green field of opportunity.” But to maximize the opportunity, we must accommodate the reality of a messier world. Social media, almost by definition, is messy – and the regulatory framework (or lack thereof) is equally so. And it’s not likely to get much better. Get used to it.
All this doesn’t mean that social media is a bad thing. Nobody said it was going to be easy. If we want to change the healthcare paradigm (and for some that’s a big “if”), then changing the way people learn, discuss and address healthcare issues is a crucial element. And, unlike other aspects of healthcare change – it is happening with great rapidity.
Impact and influence happen when what you have to share is to the benefit of the seeker — not to you. And that requires a level of focus, acumen and honesty that is always hard and often lacking – especially when it comes to healthcare marketing. As the saying goes in our nation’s capital, “if you’re not at the table, you’re on the menu.”
In the words of Winston Churchill, “Ease is relative to the experience of the doer.”
We’re still looking to healthcare professionals for technical solutions (physicians are no longer the first and last word, but the first among equals). When it comes to practical advice, it’s an increasingly peer-to-peer proposition. Today (for better or worse) we are all “learned intermediaries.” (But some as more learned than others – a fact we need to recognize and advocate.)
Welcome to the new world of P2P Healthcare where social media holds the keys to the portals of power. And as Dr. James Fowler of the University of California at San Diego, opined, “Pharma must realize their own network power.”
Social media is communications at the speed of life. As Marshall McLuhan wrote, “At electric speed, all forms are pushed to the limits of their potential."
(Still think you can wait for more precise and directive FDA regulations?)
The PDUFA "primary season" is almost over
Today, BioCentury reports, the Senate HELP Committee will deliberate on a PDUFA reauthorization bill that would relax conflict-of-interest restrictions on advisory committee members, and enact new provisions intended to improve risk-benefit decision-making, facilitate global harmonization of clinical trials and promote regulatory science.
The PDUFA reauthorization manager's amendment would eliminate limits on the numbers of conflict-of-interest waivers FDA can issue for advisory committee members. It would require FDA to "implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decision-making, and the communication of the benefits and risks of new drugs." It also would instruct FDA to work with international regulators and industry to "encourage uniform, scientifically-driven clinical trial standards" that would facilitate simultaneous global development of new medical products. Another new provision would require FDA to identify regulatory and scientific gaps that impede product reviews and approvals and draft plans with specific milestones for addressing the gaps.
The House Energy and Commerce Subcommittee on Health will mark up its version of the FDA user fee reauthorization legislation on Thursday.
Is the final vote a sure thing? Probably.
But is any election ever a sure thing?
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
