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In California, failure is not an option -- almost.
Pending legislation AB 1826, which prohibits “fail first” practices by insurers, has been steadily moving through the California Assembly and will go for a vote in the Health Committee on Wednesday, June 30.
According to the legislative language, “This bill would require a health care service plan or contracts and health insurer covering insurance policies that cover outpatient
CMS has already issued a 2010 Call Letter to limit step therapy in health plans for Medicare patients.
AB 1826 will help physicians do what they do best practice the art and science of medicine.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.
As
In California -- indeed across the entire United States -- access to care must be matched with quality of care.
Update on AHA Scientific Sessions Regarding ACCME Discussions
DALLAS, June 23, 2010 –The AHA has long believed in the integrity of science that is rigorously peer reviewed by content experts, and is absolutely independent in the positioning and delivery of its content. As noted in the ACCME statement of 6/23/10, in which they stated their belief in the value of constructive debate and input about their policies and all issues related to managing conflict of interest in accredited CME, the ACCME is committed to setting fair and reasonable standards that support education about scientific research and developments, while ensuring that accredited CME is independent and free of commercial influence. During in-depth discussions with the AHA, and after thoughtful deliberation, the ACCME agreed that AHA’s extensive internal controls assure independence, and are appropriate for CME accreditation for a scientific meeting.
Thus, there will be no variance from past Scientific Sessions and CME will be available for all presentations within the scientific program. This will insure that the flow of science will remain unfettered as it always has been and as would be in keeping with the mission of the AHA.
For those submissions that were withheld, we will reopen abstract submissions shortly and enter the newly submitted material into our ongoing peer review process.
Read More & Comment...There’s an article in today’s edition of the New York Times headlined “Debate Over Industry Role in Educating Doctors.”
Yes – there is a debate. And it’s an important one. But the article doesn’t report on the debate – it takes a stance. Consider the first 17 words of the reportage:
“In the latest effort to break up the often cozy relationship between doctors and the medical industry …”
That’s not an article – that’s an editorial.
The article throws around a lot of big numbers. For example;
“Continuing medical education has become a big business in the United States, with more than 700 accredited providers. Total spending on such courses peaked at $2.5 billion in 2007, including a record $1.2 billion paid by companies, according to the Accreditation Council for Continuing Medical Education, a nonprofit regulatory group.”
But these are numbers out of context. Statistics, as the saying goes, is like a bikini – what it shows you is interesting but what it conceals is essential. Here’s a statistic mysteriously absent from the Times story: 42 percent of CME activities have no industry support at all. Two-thirds of providers get less than 10 percent of their total revenue from drug and device companies.
Citation for that last bit of information – ACCME.
Selective reporting of the facts is unworthy of our national newspaper of record. As my grandmother used to say, “A half-truth is a whole lie.”
The complete New York Times article can be found here.
Commonwealth comes to it's usually conclusion...
U.S. scores dead last again in healthcare study
Wed Jun 23, 2010
WASHINGTON (Reuters) - Americans spend twice as much as residents of other developed countries on healthcare, but get lower quality, less efficiency and have the least equitable system, according to a report released on Wednesday.
How could the media allow the bogus, made to order, results of the Commonwealth Funds survey of health systems remain unexamined? Laziness, bias and just too busy? Here is the gist of the study:
The report looks at five measures of healthcare -- quality, efficiency, access to care, equity and the ability to lead long, healthy, productive lives. Britain, whose nationalized healthcare system was widely derided by opponents of U.S. healthcare reform, ranks first in quality while the Netherlands ranked first overall on all scores, the Commonwealth team found.
U.S. patients with chronic conditions were the most likely to say they gotten the wrong drug or had to wait to learn of abnormal test results.
"The findings demonstrate the need to quickly implement provisions in the new health reform law," the report reads.
Critics of reports that show Europeans or Australians are healthier than Americans point to the U.S. lifestyle as a bigger factor than healthcare. Americans have higher rates of obesity than other developed countries, for instance.
"On the other hand, the other countries have higher rates of smoking," Davis countered. And Germany, for instance, has a much older population more prone to chronic disease.
Some thoughts:
It is easy in any health system to find people who are happy with their health care, in Europe particularly. That permits Commonwealth from avoiding the real analytical work or confronting the reality that Britain’s NHS has severe structural problems or, that despite the market-based reforms Netherlands has instituted (oops, Commonwealth ignores that) significant health disparities between urban and rural, rich and poor, immigrants and citizens persist. The British medical journals and media are awash with studies showing that disparities are widening. Sir Michael Rawlins of NICE told me as much last year. Somehow, somewhere Commonwealth Foundation the 200 people in Britain who think the NHS is great. Maybe Karen Davis just interview Donald Berwick 200 times.
Of course the findings lead to the conclusion that Obamacare should be adopted. This is the same organization that claimed comparative effectiveness research based on the Dartmouth Atlas would save over a trillion dollars between 2010-2020. It’s easy if you use survey data instead of carefully designed studies that rely on data sets, including biomarkers, that permit reliable international comparisons over a period of time. Such as five year survival rates for various forms of cancer by stage, treatment for asthma, access to psychiatric care (mental illness is the fastest growing disease), ability for people over 65 to live without disabilities, etc. access to new treatments. If you don’t do serious research and the media just laps up your claims and findings uncritically you can say anything you want.
Read More & Comment...Pursuant to yesterday's discussion of the HHS IG's report on FDA's oversight of non-US based clinical trials, some commentary from Leslie Ball, director, division of scientific investigations, Office of Compliance, FDA Center for Drug Evaluation and Research:
"As a consequence of that report, I think we will be looking, internally, at the quality of data a little bit more critically that's conducted outside the U.S. ...That might result in some additional analysis and soul-searching about whether or not requirements need to be put in place."
A new site-selection model already is under development that will move the agency to a more risk-based approach to determine which sponsors will be inspected, Ball said.
The factors that could trigger an inspection include the drug application and trial design, or site-specific risk attributes like enrollment and drop-out rate. FDA Principal Deputy Commissioner Joshua Sharfstein said in his response to the report geography also is a risk parameter in the formula.
"We are expecting that to be a little more complex," she said. "We also want to say that just when the regulated community figures out what our risk algorithm is, we will change it. So don't get too comfortable."
FDA also already is looking to expand its partnerships with other regulators, as was recommended in the report to maximize its resources. A pilot program with the European Medicines Agency to conduct joint inspections and share other information, if successful, could lead to more collaborations with other foreign regulators.
Read More & Comment...
When it's a medguide ... maybe.
FDA is searching for a way out of imposing a REMS when only a medication guide is required.
According to John Jenikns, director of the Office of New Drugs (and the best dressed man at the FDA), having to develop and then assess the impact of medication guides as part of the REMS program is a burdensome administrative task for the agency, as well as for sponsors and pharmacies and society at large.
"We are looking to try and be creative in how we interpret that part of the statute, so stay tuned to see if we're able to find some creative ways around this," he said.
In the meantime, medguides remain a component of a REMS and "until we work through this further, there are a lot of medication guide-only REMS - a lot of burden on us, a lot of burden on you - that we'd like to try to get out of."
As of June 3, FDA had listed 123 REMS on its website. Eighty-four consist only of a MedGuide, while another 25 involve a medguide and communication plan. The other 14 REMS require sponsors to adopt elements to ensure safe use. Five of those also involve a MedGuide; three also have a communication plan; and the other six also require both a MedGuide and a communication plan.
If FDA does not find a solution it can implement itself, the next reauthorization of the Prescription Drug User Fee Act in 2012 offers an opportunity for legislative change. Industry and other stakeholders already have cited REMS as an area for focus during PDUFA V.
(And, hopefully, that's "V" like in "victory.")
The NY Times rejoinder to Elliot Fisher is devastating and could have been even more complete if Reed Abelson and Gardiner Harris had not pulled their punches on such aspects of the Dartmouth empire as it's deep involvement in and financial dependency on Health Dialog...
It also raises the stakes on the Berwick nomination since Berwick's love and faith in Dartmouth is well known and has been reciprocated. From an earlier NPR report"
ROVNER: So at first glance, the person President Obama has chosen, Donald Berwick, seems an unlikely candidate. He's a mild-mannered pediatrician and Harvard Medical School professor. But Dartmouth health policy researcher Elliot Fisher, who's worked with Berwick for years, says he's the perfect choice to implement some of the most sweeping changes to the nation's health care system in generations.
Dr. ELLIOT FISHER (Researcher, Dartmouth Health Policy): Don Berwick is a visionary leader who not only understands health care, but also understands and has shown that he can help physicians, nurses and hospital leaders work together to improve the care that patients receive.
www.npr.org/templates/story/story.php
I smell hypocrisy and an unwillingess to respond to this important question.
Read More & Comment...
Senator John Barrasso (R,WY) on Health Care Reform from CMPI on Vimeo.
Read More & Comment...
Once you get past the wonk talk about Markov estimates and parametric projection models the key considerations were the following:
"no data for the stable disease subgroup were provided to allow separate consideration of the use of erlotinib in squamous and non-squamous disease. Furthermore, no evidence was provided comparing erlotinib with pemetrexed in patients with non-squamous disease who have stable disease after first-line treatment."
And,
"The Committee discussed whether the SATURN study could be generalised to UK clinical practice and noted that there were few UK patients and a high proportion of patients from Southeast Asia in the study. The Committee noted a comment from the ERG that Asian people are known to respond better to lung cancer treatments than other races. The Committee heard from the clinical specialists that there are no significant reasons why the relative benefit of erlotinib in the SATURN trial would not also be seen in the UK population."
And
"It also heard from clinical specialists that patients with EGFR mutations have a longer natural history of disease and a better prognosis than other patients with non-small-cell lung cancer. The clinical specialists also commented that the small proportion of patients with EGFR mutations in the SATURN trial would be similar to the UK population. The Committee noted that no one in the SATURN trial had received first-line treatment with pemetrexed and cisplatin, which is now becoming a commonly used combination chemotherapy regimen for patients with non-squamous disease. It therefore concluded that there was uncertainty about the clinical benefit of erlotinib in patients who had previously received pemetrexed and cisplatin."
Do I think Tarceva should not have been approved. No. Because it would make more sense to allow reimbursement, encourage biomarker development and contribute to personalized medicine.
But the NICE consultation process reveals a deeper appreciation of the role of biomarkers in evaluating treatment effectiveness than the current bone headed approach being funded by AHRQ.
www.nice.org.uk/guidance/index.jsp
effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/
Read More & Comment...
Once more into the abyss.
But transparency is no longer good enough for the ACCME – now they want purity – whatever that means.
When is a conflict not a conflict? The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.
In the February 7th edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.
The new dictate by the ACCME is the COI polloi out of control. Consider the comments of healthcare icon and NIH director Francis Collins:
"It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector.”
Big Pharma hires the best. And now America’s physicians are being denied their counsel.
Do we really want to build the foundation of 21st century CME on the second best and the almost brightest?
Interesting story in yesterday’s edition of the St. Louis Post-Dispatch about Express Scripts and its president, George Paz (who is referred to in the article as a “former accountant").
Mr. Paz -- “The cheapest drugs is (sic) where we make our profits.” To that end, the article points out that in 2008, “Express Scripts agreed to pay $9.3 million to 28 states and $200,000 in reimbursement to consumers to settle lawsuits that accused the company of deceptive business practices in allegedly overstating the economic benefits to consumers of switching to certain drugs.”
And yet:
“Express Scripts would like to extend its influence further. Plans are in the works to put information kiosks in doctor's offices to advise patients about cheaper alternatives to brand-name drugs.”
Not “better.” Not “more effective.” Not “safer.” “Cheaper.” Can you imagine what would happen if a pharmaceutical company wanted to try something like this? Can you say “congressional investigation?”
And just who is “cheaper” better for?
"Our whole model is switching people to lower-cost drugs," Paz said. "The more money my shareholders make, the more money I make."
(According to the Post-Dispatch article, Mr. Paz’s compensation, including bonuses and other incentives, totaled $10.6 million in 2009.)
This is sadly reminiscent of the Blue Care Network of Michigan program (now discontinued) that sent letters out to their participating primary care physicians offering a $100 payment “for each member in their panel with a BCN pharmacy benefit who fills a prescription for a generic lipid lowering agent.”
Per an ABC News investigative report, “Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.” In other words, we’ll pay you $100 to switch your patient to a generic statin that isn’t even a generic version of what they are currently taking.
When asked by the ABC reporter if patients knew their doctors were receiving payments from the insurance company in return for a service that helps to increase the profits of the insurance company, the response from BCN was “not specifically.”
A study fielded by the National Consumers League demonstrated that switching a patient to a generic medicine doesn’t always result in positive outcomes:
- 15% of general Rx users saying that they or a family member experienced therapeutic substitution
– Nearly half of Rx users (47%) were dissatisfied (or their family was) with how the process occurred and report that this substitution did not result in lower pocket costs.
– More than a third (40%) said that the new medication was not as effective as the original one, and nearly a third (30%) experienced more side-effects following the substitution.
– Large majorities of Rx users think that the potential side effects of the new medication, the patient’s medical history, how well the drug works and the prescribing physician's opinion are factors that are absolutely essential when decisions are made about therapeutic substitution.
Just as no two patients have the same biochemistry, no two medicines are exactly equivalent. But if your primary goal is to reduce short-term costs, that's an inconvenient truth.
The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.
Read More & Comment...http://content.nejm.org/cgi/content/full/NEJMp1006304?query=OF
The key paragraph is:
"The challenge is to deliver the benefits of this work to patients. As the leaders of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), we have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time."
Sadly not everyone shares their commitment. There are those in the agencies both of them lead who oppose their vision. I know since I have met and heard them speak. One of them -- from the NIH -- called the ALLHAT study the "gold standard" of evidence-based medicine. Must have received his MD from the Rosa Delauro School of Biomarker Science (Merrill Goozner, Dean of Academic Research).
At the same time, personalized medicine does not automatically translate into faster approvals. It would be easy to chalk this up to agency risk aversion across the board. Rather, I think it is more a matter of over time that the regulatory system has been able to become bloated and expensive because the way health care technologies have been paid for allowed both industry and government to pass the cost of oversight on to consumers, inefficiencies and all. Is the process of developing new medicines risky and expensive? You bet it is. But could it be less so and could industry made or demanded more efficiencies in product cycles and manufacturing? Absolutely. And will more of the fate and future of a produce be determined in the market rather than in the clinical period. That will be true as well. Especially when in comes to finding new uses based on the same pathways in different diseases or disease sites.
So faster approvals will still matter, but faster adoption or approvals for new uses will likely matter more. Which means getting to "no" faster in the early stages of development and finding multiple uses in the real world. And both will depend on personalized medicine as defined by Drs. Hamburg and Collins.
The recent 500-page IOM/National Research Council report on the state of FDA’s food regulatory shortcomings is 500 pages of stating the obvious. To conclude that the FDA needs to do more more efficiently does not, shall we say, provide a memorable “aha!” moment.
In July 2003 the FDA issued its Task Force on Consumer Health Information for Better Nutrition Initiative report.
According to the Task Force (on which I was honored to serve), “A better-informed public, supported by effective, science-based regulation of health information, would be expected to make better nutritional choices.”
A sound hypothesis and a noble mission. Unfortunately, the road to better health through better nutrition remains paved with only good intentions. That needs to change. Unfortunately, the IOM/NRC report doesn’t even give passing lip service to this important agenda. Instead, it goes off into the political nether Never Never Land of a “single food agency.” A docket item almost guaranteed to mire any action in political and bureaucratic in-fighting for the foreseeable future.
In 1990 Congress passed the Nutrition Labeling and Education Act, which established the FDA-regulated Nutrition Facts Panel (what most civilians refer to as “the food label) “to assist consumers with healthy dietary practices.” The fact that the “E” in NLEA remains silent continues to go sadly unrecognized, unreported -- and unaddressed. And that’s a real disservice to the public health.
The federal government is trying some humorous scare tactics in a new ad campaign to persuade men to get recommended checkups, today’s WSJ reports.
Experts warn that men’s reticence about going to the doctor — men are 24% less likely than women to have made a routine care visit in the last year — could translate into higher costs of care for a flood of aging Baby Boomers. “In the next 20 to 30 years we are going to see an increase in the population of men who have had virtually no preventive care,” says John Morley, an endocrinologist and geriatrics specialist at Saint Louis University School of Medicine in Missouri. “Men have to be much more aggressive about getting involved in their own health.”
The list of tests men should consider is based on recommendations from the U.S. Preventive Services Task Force, and is limited to screenings that evidence shows are effective for routine use. Those include blood pressure and cholesterol screening, as well as screening for depression and sexually transmitted diseases.
But experts say men also need to talk to their doctors about the risk of developing diseases that aren’t screened for using the recommended tests. For example, the death rate for skin cancers is steadily rising among middle-aged and older men, with white males over 50 making up nearly 50% of all melanoma deaths in the U.S. The USPSTF says there is insufficient evidence to recommend routine body checks for skin cancer, but a study last year in the Archives of Dermatology found that by delaying seeking care for melanoma, men more often present to doctors at a later stage when it is no longer treatable. Cancer groups and dermatologists have stepped up efforts to target men — especially less-educated, middle-aged and older men — to encourage self-exams of the skin to look for changes in moles, since early detection can improve survival.
Prostate cancer, meanwhile, is the second leading cause of cancer death in men after lung cancer, but the task force doesn’t recommend routine screening; for men younger than 75, it says, the benefits are uncertain and the balance of benefits and harms can’t be determined; for men over 75, there is moderate certainty that the harms of screening outweigh the benefits, according to the task force. The USPSTF recommends that doctors discuss the harms and benefits of prostate cancer screening with their patients before performing screening procedures.
The recommendations don’t necessarily affect coverage decisions. For example, for beneficiaries aged 50 or older, Medicare covers one test each year for the two most common tests to detect prostate cancer: the prostate specific antigen (PSA) blood test, and the digital rectal examination (DRE).
In addition to print and broadcast ads that portray Dad as doomed if he doesn’t get his preventive screening tests, the Agency for Healthcare Research and Quality has developed an “e-card” for people to send to their fathers to remind them to go get preventive care. It’s available on the AHRQ’s website by clicking on the button that says: “Get Dad to the Doc.Read More & Comment...
No Refills - Magazine - The Atlantic
Megan McArdle's article on why there are fewer drugs approved is well taken and is actually not new, just lost in the stupid way the media reports on the FDA. I also take strong exception to the claim that conservatives blame the FDA. Five years ago I chaired a task force, established by the late Joshua Lederberg, to look at how the FDA was using regulatory science based on new genetic and clinical insights used to discover new targets to change medical product development. The Critical Path initiative was established to create a new set of tools for this purpose, tools that would help individualize risk and benefits. Those who use Big Pharma to attack commercialization have sought to undermine the Critical Path because it eliminates unexpected fear as a political weapon. Those who attack "biomarkers" as another way companies can market new, ineffective drugs willfully fail to grasp the fact that the principal barrier to approval is the absence of well validated markers. And the attack comes from the right and the left.
The report can be found here: www.manhattan-institute.org/pdf/CMP_FDA_Task_Fo...
Read More & Comment...
"India may send health officials to China to inspect manufacturing units of bulk drug suppliers to the South Asian nation to prevent cheap imports, the Press Trust of India reported, citing a government official it didn’t identify. Health officials want to verify drugs supplied to India are made at units certified by government agencies, the news agency said." Read More & Comment...
Much chatter about David Graham and his leaked Avandia report. It’s turning into a real whodunit. And it’s more complicated than it looks.
First, it’s important to understand that the FDA had already approved Dr. Graham’s request to submit his manuscript to JAMA. So the report (in the Wall Street Journal) that, “… Dr. Graham complained that senior FDA officials were holding up his efforts to publish his work,” is just completely wrong.
So why would Graham leak the report and torpedo his chances of getting it peer-reviewed and published? A few theories are being floated:
(1) The manuscript had been submitted and rejected by JAMA. So spurned, Dr. Graham took the next most expedient step and leaked his report.
(2) Same as above, except the leak came from a supporter inside JAMA either with or without the knowledge of Dr. Graham.
(3) JAMA accepted the paper but determined that it would also offer the FDA or GSK or both a chance for rebuttal. Dr. Graham or a JAMA editor felt this wasn’t fair and leaked the document.
(4) The report was leaked by some else inside the FDA.
Or, in the words of Sherlock Holmes, “When you have eliminated the impossible, whatever remains, however improbable, must be the truth.”...
Whatever the truth, “leaking” a confidential FDA report is not the act of a whistle-blower. Whistle-blowers have the courage of their convictions and are (appropriately) protected. Leakers, on the other hand, are just cowards with an agenda.
At the end of the day, the only thing that counts is that the FDA reach its conclusions based on sound science and not on media leaks – or politics.
Read More & Comment...It should be in a loose leaf folder.
The most recent example is the article in today's WSJ:
FDA Scientist Attacks Avandia Safety
By JEANNE WHALEN And ALICIA MUNDY
Medicare patients in the U.S. who took GlaxoSmithKline PLC's diabetes drug Avandia may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009 that could have been averted had they taken a different drug, a Food and Drug Administration scientist contends in a new study.
The unpublished study by outspoken Avandia critic David Graham, an FDA drug-safety official, echoes his earlier assertions and another study led by the Cleveland Clinic's Steven Nissen that linked Avandia to additional heart attacks and strokes.
The FDA is scheduled to review the drug's safety in a meeting next month. Dr. Graham and others have argued that Avandia should be withdrawn from the market. An FDA official said Thursday that Dr. Graham's study would be included in safety data to be reviewed for that mid-July meeting.
Why should it be included? Or rather, why, since it is just another example of assuming the worst based upon questionable data, is it being included at all.
Because the media and pols pressure the FDA to include it, whether it is crap or not.
Oh, but wait, this isn't just ANY study. This one was
"first published by the Pharmalot blog, which also posted a May 28 email from Dr. Graham to the FDA's senior leaders. In it, Dr. Graham said he wanted to submit the study to the Journal of the American Medical Association for publication. The Pharmalot blog is a respected blog covering the pharmaceutical industry written by Ed Silverman, an editor at large for the industry publication Med Ad News.
In the email, Dr. Graham complained that senior FDA officials were holding up his efforts to publish his work. However, an FDA official, who confirmed the email, said Thursday that the agency isn't suppressing the study and that it was subsequently submitted to the journal.
A JAMA spokeswoman said the journal doesn't ever confirm or deny receipt or acceptance of any manuscript until publication. Dr. Graham couldn't immediately be reached for comment."
We all know that respected peer-reviewed medical journal Pharmalot, which of course does not accept any advertising.
(Drugwonks is respected too but if we were part of such a stunt the Tabloid Medicine machine would rise up in anger and call us tools or something,)
In any event, the preceding is just fancy footwork around having to undergo peer-review (which for an article like this should not be a hard sell at JAMA) and to make all sorts of claims without having to answer serious questions. One of them being, if Nissen showed 43 percent increase risk cherry picking data even as he consults for Takeda, a company making a competitor product, how do you explain the 25 percent figure Graham came up with. Confidence intervals anyone? A second one, is this claims data (yes) and was it adjusted for severity of illness (no) and how many people were on multiple medications (many). Is there a dose effect. Perhaps and in my next blog I will take this on. Third, and the one the FDA will seek to address in adult fashion, do the risks of any of these medications (which all drugs carry) outweigh benefits with respect to controlling progression? The answer is likely no.
So here's the difference, traditional science is rapidly moving towards the personalization of medicine using biomarkers and real-time clinical data. In this new world, risks and benefits can be adjusted more precisely.
Meanwhile the Tabloid Medicine machine -- which includes Nissen, Graham, Mundy, Silverman, Grassley -- see risk everywhere and insist upon a system that seeks to anticipate every risk before it happens.
As Cass Sunstein has noted, the precautionary principle, with it's standard of not allowing any technology absent evidence of zero harm, carries it's own risks. One of them is that people will stop taking medicines that help, including Avandia. The other is that medical innovation will slow to a crawl and that personalized medicine in particular will be crushed by those who, because of cultural and ideological biases, will spread rumors about risk in a unscientific and unbalance fashion. More people will be harmed by adopting the slant of this most recent article in the WSJ.
Where you stand often depends on where you sit. Former Governor George Pataki supports repeal and reform. Some are for, others against. Judge for yourself via this recent interview with the former Empire State Chief Executive.
One thing he points out that we can all agree on is that this shouldn’t be a debate about politics – but rather about policy.
Read More & Comment...
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