Latest Drugwonks' Blog
Sorry if I caused any marcomms gyrations.
(But it's still a good idea to replace ambiguity with some clarity in the social media space.)
FOR IMMEDIATE RELEASE
April 1, 2009
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New FDA Draft Guidance Aims to Improve Health Information Obtained via “Social Media” Websites
The Food and Drug Administration today issued a draft guidance document designed to improve communications to consumers and health care practitioners about health conditions and medical products that they obtain on “social media” Websites such as Facebook, YouTube, Twitter and online bulletin boards. The guidance is the result of FDA research and policy development, and was influenced by the success of the recent social media based peanut recall program.
"We intend to do all we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible," said acting FDA Commissioner, Dr. Joshua M. Sharfstein. "Our new regulatory guidance provides new direction to sponsors on how to provide higher-quality health information to the public via social media sites, based on recent evidence on what works and what doesn't. The evidence shows that social media promotions directed to consumers can play an especially important role in helping patients start a discussion about conditions that are often unrecognized and therefore undertreated, such as diabetes, high blood pressure, high cholesterol, depression, and obesity. And we think those discussions should reflect a better understanding of the key risks and benefits of a product. Without participation by pharmaceutical companies in those discussions, there is increased likelihood of false or dangerous information being promulgated throughout the Internet."
According to an FDA study, a majority of interactive agencies surveyed feel that social media product messages increase patient awareness and involvement, and improve compliance. That study also shows that social media-stimulated visits to a physician can help identify a previously undiagnosed condition. Importantly, of patients who visited their doctors because of an online discussion they participated in, 95% actually had the condition the drug treats. That percentage was even greater than that reported among patients who viewed DTC ads on TV.
The draft guidance provides (1) a simple method by which sponsors can insert a notice about reporting adverse events in their posts to social media sites, (2) “safe harbor” conditions that relieve manufacturers of responsibility for reporting adverse events they may hear about on social media sites, and (3) advice for manufacturers on the types of branded and unbranded communications that fall under the rules set forth in the guidance.
"Clear, evidence-based regulatory guidance will help FDA use its limited resources to police the marketplace as effectively as possible," said Sharfstein. "FDA will take action against sponsors whose ads violate the law by presenting false or misleading information to the public via social media sites. Our new draft guidance is intended to help responsible companies comply, for the benefit of the public health. If they don't, we now have an even stronger basis for pursuing enforcement actions."
More on this to be sure.
As you have surely seen, a group of the usual suspects, often referred to in the media as “a group of leading doctors and researchers” (WSJ) is calling on medical associations to forego funding from drug and device companies.
At the just-completed
And healthcare in
Maybe not.
According to ACC’s chief executive Jack Lewin, drug and device companies, “have zero impact on the content of any program here” He also said banning industry support could force a spike in registration fees, discouraging doctors from attending.
You can look it up under “Pyrrhic Victory.”
If you work for a pharmaceutical company, ask yourself this question: What business are you in? To the average American, you are in the business of selling. To survive and thrive you must be in the business of advancing the public health. And to do that you must be seen as both teacher and expert.
By: Marilynn Marchione, Ap Medical Writer – 2 hrs 38 mins ago
ORLANDO, Fla. – A single daily pill that combines aspirin and four blood pressure and cholesterol medicines has passed its first big test, potentially offering a cheap, simple way to prevent both heart disease and stroke.
The experimental "polypill" proved as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a person's risk of heart disease and stroke roughly in half, the study concludes.
This "one-size-fits-most" approach could make heart disease prevention much more common and effective, doctors say.
"Widely applied, this could have profound implications," said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke University's heart research institute. "President Obama is trying to offer the greatest care to the greatest number. This very much fits in with that."
The polypill also has big psychological advantages, said Dr. James Stein of the University of Wisconsin-Madison.
"If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden," and respond by skipping doses, he said.
The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John's Medical College, Bangalore, India. Results were presented Monday at the cardiology college's conference in Florida and published online by the British medical journal Lancet.
The study tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the "water pill" thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).
Participants were about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease — high blood pressure, high cholesterol, obesity, diabetes or smoking.
Four hundred were given the polypill. The rest were placed in eight groups of 200 and given individual components of the pill or various combinations. Treatment lasted 12 weeks.
Compared to groups given no blood pressure medicines, the polypill lowered systolic blood pressure (the top number) by more than 7 units and diastolic (bottom number) by about 6 — comparable to levels for people given the three drugs without aspirin and the cholesterol drug.
LDL, or bad cholesterol, dropped 23 percent on the polypill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10 percent on the combo pill versus 20 percent with individual statin use. Neither pill affected levels of HDL, or good cholesterol.
Anti-clotting effects seemed the same with the polypill as with aspirin alone.
Side effect rates also were the same for the polypill as for the five separate medicines.
"That was a big surprise. I would have expected five times the number of people to have side effects," said Dr. Christopher Cannon, a cardiologist at Harvard-affiliated Brigham and Women's Hospital in Boston who had no role in the study.
Collectively, the results show the polypill could cut the risk of heart disease by 62 percent and the risk of stroke by 48 percent, based on what previous studies show from lowering risk factors by these amounts, the study concludes.
Polycap's maker sponsored the study, and Yusuf has been a paid speaker for several makers of heart drugs. No price for the polypill is available, but its generic components cost only $17 a month, Cannon said.
A bigger study is now needed to see whether the polypill actually does cut heart attacks and strokes, he wrote in a commentary in the medical journal.
"It won't be for everybody," he said. Some people would be overtreated by getting medicines for conditions they don't yet have, such as high cholesterol. Others may be undertreated by too-low doses in the combo pill. Several polypills of different strengths may be needed, Cannon said.
"We have to be cautious about assuming that one size fits all," Stein said. "Treating risk factors is a lot like cooking — the ingredients count."
A polypill also would need federal Food and Drug Administration approval, even though all of its components have long been sold separately. The dosing issue could become a regulatory nightmare, Cannon warned.
"A final challenge: would the availability of a single magic bullet for the prevention of heart disease lead people to abandon exercise and appropriate diet?" he wrote in the medical journal.
That could make the risk of heart disease worse, and undo the good of the drug, Cannon said.
My mother didn't like to cook -- but she wanted her family to have "balanced" meals. (Remember "balanced" meals?) The results were predictable and adequate. (Sorry Mom.)
Similarly today, our comparative effectiveness nabobs want to field "comparative effectiveness" studies that don't make them think too hard. These studies (outlined here) will result in predictable findings based on "adequate" 20th century science that don't challenge any conventional wisdom. If we want real healthcare form -- is adequate acceptable?
No! No! No!
Literature reviews do not replace robust 21st century science.
“Comparing Drug Treatment Effectiveness in Ethnic Minority Populations. Research suggests that treatment response can vary among different minority populations due to genetic, environmental and cultural factors. Still, it is unknown which treatments work best for which ethnicities. Comparative effectiveness studies in ethnic minorities would test pharmacotherapies and behavioral treatments for substance abuse that have already shown efficacy in some populations. Results could reveal optimal treatment types for various populations, many of which are currently under-studied or under-served in terms of treatment need, including African Americans, Native Americans, and Hispanics. “
Comparative Effectiveness Research on Cancer Screening. The effectiveness of cancer screening has been established through randomized trials and other evidence for breast, colorectal and cervical cancer. However since screening for these cancers were initially introduced, there has been rapid and substantial innovation in new early detection technologies. Many of these technologies have disseminated into the practice of screening but without sufficient evidence as to their comparative effectiveness relative to earlier established technologies. In addition newer technologies may influence how the earlier technologies are most effectively used. Comparative effectiveness research in this area would augment evidence from controlled screening trials with: data from observational studies in defined populations of screening, intermediate and final outcomes; head-to-head studies of the technical performance characteristics, physician and patient acceptability and cost of alternative screening technologies, and decision models designed to project the costs and benefits of different screening technologies and strategies over the long-term at the individual, program and policy level
Comparative Effectiveness Studies of Non-Pharmacological Treatments for Chronic Low Back Pain. Observational studies or secondary data analyses to compare the effectiveness of: non-pharmacological treatments or integrative health care approaches for chronic low back pain when used in addition to and/or as an alternative to standard conventional care.
Comparative Effectiveness Research in Cancer Primary Prevention. A number of chemoprevention agents have been shown to be potentially effectiveness for the prevention of common cancers. But dissemination of chemoprevention remains low and controversy remains about the side effects associated with these agents. Comparative effectiveness research in this area would have the following aims: to document the level of dissemination of chemoprevention agents and the examine the physician, patient and health system factors that either facilitate or retard this dissemination; to conduct head to head studies of alternative chemoprevention agents and or approaches (e.g. risk stratification) to determine the relative clinical risk and benefits and economic cost of these alternatives. These studies could be conducted as adjuncts to existing controlled trials, as retrospective analysis of health system data or as prospective studies of cohorts of patients and physicians within the context of various healthcare delivery systems.
Selecting the Optimal Initial Treatment Regimen for Patients With Newly Discovered Type 2 Diabetes. The natural history of type 2 diabetes, treated by widely used current regimens, is marked by gradual increases in glucose levels, loss of insulin secretion, progressive increases in drug therapy, and frequent development of chronic complications. Clinical trial data suggests that aggressive early therapy attempting to keep glucose levels near normal is associated with a more benign long-term course. The optimal treatment regimen (effectiveness and avoidance of hypoglycemia) is not known, but current drugs provide options for multiple treatment approaches. In view of the numerous options, pilot studies are needed to assess the short-term effectiveness of common treatment strategies.
Personalized drug response and toxicity. Application of pharmacogenetics and pharmacogenomics, quantitative and systems pharmacology (this could be part of a larger grouping to include systems biology and systems genetics), ADMET pharmacology, preclinical models, and new technologies and approaches to complement pharmacogenomic studies to enhance signal-to-noise ratios and aid mechanistic studies, and consensus standards for normal and altered phenotypes in drug response and toxicity.
Imaging and Fluid Biomarkers for Early Diagnosis and Progression of Aging-related Diseases and Conditions including Neurodegenerative Diseases. Diseases and conditions of aging have a huge public health burden, and the ability to diagnose these early and follow their course would greatly help in treating and managing them.
To witness, check “The black book on hospitals” (Livre noir des hôpitaux, Calmann-Lévy 2009) which enumerates an awful range of black spots, mishaps and tragic deaths of patients who nevertheless had full faith in the French model and universal care.
That figures; what about statistics? Try this one for size: on average 40 deaths every day, in terms of “undesirable events”. Obviously this figure covers more than people dying from medical errors, negligence and other mistakes in the hospital environment. The ballpark ranges from 350,000 to 460,000 deaths annually for hospital stays, of which some 120,000 to 190,000 might have been avoided, according to the authors.
Anecdotal evidence attests that astonishing number of physicians in the (public) hospital environment are either alcoholics, drug addicts or afflicted by some mental disorder. For obvious reasons, no statistics on this scandal are readily available; but how come these people, albeit hopefully a minority, are still allowed to practice? (Just imagine having surgery by a psychotic doctor!)
The primary reason is simple: hospital doctors (or nurses) are government employees and thus enjoy life-time employment. Any private company would try (with difficulty but still) to fire such people, especially in view of their life-or-death responsibilities.
France retains the advantage of a relatively dynamic private sector; but although private clinics are a lot more efficient and benefit from a much lower budget, they are under constant political assault. The budget divide is roughly 80/20 in favour of state-run hospitals. Nevertheless, France is world champion of hospitals/clinics per head: one institution per 20,000 people compared to one for 40,000 people on average in Europe.
The private sector has an obligation to perform; this is where most of restructuring has taken place for economic reasons. The public sector has an obligation to ask for greater budgets despite decreasing results.
Cherchez l’erreur.
Or profit.
Because follow on biologics are no more copycats than my two children are copycats because they came from the same combinnation of DNA. You can't even say that about twins.
Needless to say, just by ignoring all the science and safety concerns and searing them into law doesn't make follow on biologics similar in structure, treatment or safety. It's just saying they do. Hell, in the Waxman bill you can even take the innovator's name. Why not just take over the company?
The propnents of a short cut to follow on products want to do testing...it's just that they want the testing to be unsuspecting doctors and patients who will not be told they are being put on an imitation until after the fact. Post market safety commitments? Why, that's just for start up biotech companies with no cash flow and only five years of market or data exclusivity... And by they way, forget about tracking safety if the killer takes on YOUR name.
Okay – so just what exactly is a Quality Adjusted Life Year (QALY)?
“A QALY scores your health on a scale from zero to one: zero if you're dead and one if you're in perfect health. You find out as a result of a treatment where a patient would move up the scale. If you do a hip replacement, the patient might start at .5 and go up to .7, improving by .2. You can assume patients live for an average of 15 years following hip replacements. And .2 times 15 equals three quality-adjusted life years. If the hip replacement costs 10,000 GBP to do [about $15,000], it's 10,000 divided by three, which equals 3,333 GBP [about $5,000]. That figure is the cost per QALY."
So, how much is a year of life worth?
"The most controversial area is where you place the dividing line between what is cost effective and what is cost ineffective. That is the "how much is life worth?" question. And there is no real empirical research to guide you. We have looked at what other government departments do. Our Department of Transport, for instance, has a cost-per-life-saved threshold for new road schemes of about about 1.5 million-pounds-per-life, or around 30,000 GBP per life year gained. The judgment of our health economists is that somewhere in the region of 20,000-30,000 GBP per Quality-Adjusted Life Year (QALY) is the [threshold], but it's not a strict limit."
That's a tough decision to make for bureaucrats, is it not?
"For many difficult questions, we capture public preferences by our citizens council, a representative sample drawn from the general public. For example we asked if should we give greater priority to children than the elderly. The group decided that a year of life was worth just as much when you are a grandparent as when you are a child. That is very culturally specific and might not apply to other countries in the world."
Thanks Sir Michael.
But, according to Dr. Frank Lichtenberg of Columbia University, for a healthcare technology assessment (HTA) scheme (such as the NICE model) to yield valid decisions in practice, it is necessary to have reliable estimates of:
ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)
And his main point is that the devil is in the details.
Lichtenberg believes that incorrect estimates of some or all of these key inputs are often used:
ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated
And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.
Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?” and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing” -- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.
Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:
Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States
Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,” The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.
and
Murphy and Topel: The value of a life year is $373,000.
Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,” Journal of Political Economy, 2006.
Attention must be paid. Hello NICE. Hello IQWiG. Hello Senators Baucus and Conrad.
If the devil is in the details (and it is) -- it's time for a deep dive beyond simplistic and self-serving "comparative effectiveness."
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.
