Latest Drugwonks' Blog
This time it's soda, or as we call it in Rochester NY: pop.
Add soda to the list of other things CSPI believes are dangerous including prescription drugs, french fries, Chinese food, plastic, food coloring and transfat (the latter was something CSPI pushed to get introduced in the food supply during the 1980s.)
What CSPI does is find things that sound scary, link them to cancer and other ills in RATs. It then raises money through newsletters and lawsuits.
There is no evidence, but for the CSPI study, that any of the above cause cancer or heart disease or anything else. As one FDA official said about the soda scare study:
"A consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents," said Doug Karas, an FDA spokesman, in a statement.
http://www.reuters.com/article/2012/03/06/us-us-regulators-dispute-idUSTRE8250W620120306
Meanwhile, little infants can swallow dozens of magnets and, thankfully, survive:
PORTLAND — A 3-year-old girl was recovering Monday at Legacy Emanuel Hospital after doctors removed 37 'Buckyballs' magnets from her intestines.
Payton Bushnell complained to her parents of symptoms that resembled the flu, Legacy spokeswoman Maegan Vidal told KGW. Then, they took her in to get checked.
Doctors took an X-ray and found the balls, clustered in her stomach. She was expected to fully recover and was listed in good condition Monday morning. She has been in the hospital since Feb. 21.
The Oregon toddler was fortunate. In 2006 the government warned about risks from magnets used in toys after at least one child died and almost 19 were injured. As a result, the Consumer Product Safety Commission recalled almost 4 million Magnetix building sets and magnets were included in holiday warnings about dangerous toys. The risk occurs when a child swallows one or more small magnets, which can link together in the digestive tract and perforate the intestines.
http://today.com
Could it be that swallowing buckeyballs is less toxic than swallowing junk science from CSPI?
I wouldn't even try that experiment on rats.
BioCentury reports:
PCORI board votes on research definition
The Patient Centered Outcomes Research Institute (PCORI) board voted 17-2, with one abstention, to adopt a definition of patient-centered outcomes research that begins with a broad summary followed by a list of characteristics. According to the definition, such research "helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options." The research evaluates preventive, diagnostic, therapeutic, palliative or health delivery system interventions; focuses on outcomes such as survival, function, symptoms and quality of life; incorporates a variety of settings and diversity of participants; and "investigates optimizing outcomes while addressing burden to individuals, resource availability, and other stakeholder perspectives."
The definition does not mention "comparative effectiveness research." PCORI's methodology committee, which drafted the definition, said the research includes many components of comparative effectiveness but is intended to be "broader."
Several board members voiced concerns about the definition's focus on communication and decision-making. NIH Director Francis Collins said the definition does not emphasize research, which he called the "primary function" of patient-centered outcomes research. However, the members also expressed a desire to adopt the definition to allow PCORI to focus on other goals such as developing research priorities and launching an annual research conference. Created by the Patient Protection and Affordable Care Act, PCORI expects to have about $112 million in funding for 2012, of which $90 million will be used for grants.
Dr. Collins’ concern isn’t new. At past meetings, when the discussion of what PCORI’s “legacy should be, the NIH Director said that if the Institute was looking for a unique and non-duplicative research agenda, it would be “a null set.”
PCORI should not forget about outcomes data. Perhaps the institute should lead the way in coordinating the many large data sets of outcomes data held by both Uncle Sam and private payers. The use of outcomes data needs to go beyond (well beyond) well-intentioned (but relatively small) CMS pilot projects. The United Kingdom has such a nationwide system – but hasn’t been particularly creative or aggressive in using it. PCORI should take the lead. After all, what’s more patient-centered than real world outcomes data?
PCORI should create a program on educating patients, physicians and payers on the use and importance of molecular diagnostics. After all, what’s more patient-centric than early diagnosis and advancing the “four rights” of the right medicine in the right dose to the right patient at the right time?
PCORI should help to advance the nascent science of adaptive clinical trials. After all, what’s more patient-centric than adaptive clinical trial information?
PCORI should stay as far away as possible from discussions of CER as a method for cost controls – as this is a slippery slope to price controls. And price controls equal choice controls. Moreover, PCORI is officially tasked not to pursue comparative effectiveness but comparative clinical effectiveness. Comparative means which treatment (or healthcare technology if you prefer) is “better” (subjective) versus data on real world clinical outcomes. To put it bluntly, “comparative” is subjective. “Clinical” is outcomes-driven. It’s important to remember both the letter and the spirit of the stature.
(In fact, Francis Collins warned the board to “beware of the tension between CER and personalized medicine.)
PCORI should be careful in creating a databank of CER studies because (and particularly when you consider programs such as CATIE and ALLHAT) garbage in, garbage out.
PCORI should beware of information sharing via academic detailing. (Note: 20% of the PCORI budget is ear-marked to AHRQ for “information dissemination.) ‘Nuff said.
PCORI should (indeed must!) define “patient-centered” as care first and cost second – otherwise the “PC” in its acronym will only mean “politically correct.”
In May 2011, PCORI Chairman Eugene Washington introduced Joe Selby as the institute’s first executive director. To which Dr. Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”
Joe – It might be time for those night vision goggles.
http://www.washingtonpost.com/wp-srv/special/business/high-cost-of-medical-procedures-in-the-us/
His blog is a textbook case of how most health care policy research is a combination of liberal bias and mythic numbers that support a point of view.
Here's the reason medical procedures cost more in the US. The cost per procedure does not reflect the government subsidy that artificially reduces prices and drive up demand. Second, the cost per procedure is not the only thing that's controlled. Waiting is part of the cost per procedure in Europe, Canada and elsehwere. Ask someone who has to wait for cancer surgery if the lower cost per procedure is worth it. Would people pay more to get care faster? They do quite often. Yeah, neonatal intensive care in the UK or Canada is cheaper. So if infusion of biologics. But there's a reason people come to the US from Canada to get neonatal care. There's more of it when you need. You see Ezra, if price doesn't reflect both the true cost - and value -- of a product, people won't produce it. Unless you are Solyndra or GM's Chevy Volt. Both are -- or were heavily subsidized -- products that no one wanted.
Which is sort of like health care around the world. And medical innovation. Government controls also skew what will be produced. Innovation and its diffusion is stifled by things like price controls and comparative effectiveness reviews. Both raise the risk and cost of development and CER delays and reduces market access. So the way to make a buck is to pump out marginally better products that will get you a slightly higher launch price.
The US still leads in the number of new drug launches compared to other nations because we reward biomedical innovation, at least for now. Meanwhile, medical device adoption is faster in Europe. Cycle times matter more in medical devices and Europe is not as anal-retentive about follow on devices as is our FDA. Add a medical device tax to the equation and the decline in innovation will accelerate.
Klein rehashes the 'research' of Gerard Andersen, a hack who makes a living producing memos for congressional Democrats that confirm their belief that price controls would work just fine. Andersen pushed having Medicare 'negotiate' drug prices like the Veteran's Administration. ( Here's a link to a Frank Lichtenberg study I sponsored a few years ago. http://democrats.veterans.house.gov/hearings/Testimony.aspx?TID=59775&Newsid=470&Name=%20Frank%20R.%20Lichtenberg,%20Ph.D. ) And the association between controls on innovation and reduced health care well established. Lichtenberg has looked at access to new cancer drugs in Europe and Australia and concluded that for most types of cancer, newer drugs save lives and displace most costly care.
That's the same VA whose formulary and price controls reduce access to new drugs and reduce the life span of seniors. Which I guess saves money too.
I don't mean to single out Klein. It's just that his blog -- a blog! -- is an example of the confirmation bias that passes for policy analysis. Blogs are thought experiments, not science. And when they rely upon leftwing ideologues with tenure -- like Gerard Andersen -- to prove a point they reduce the sum of human knowledge each time they are read or written.
Generic Drugs' Effect on Health Costs Unclear, GAO Says
By Emily P. Walker, Washington Correspondent, MedPage Today
WASHINGTON -- Generic drugs were substituted for brand-name drugs 93% of the time in 2010, but whether increased use of generics is actually saving money is up for debate, according to the Government Accountability Office (GAO).
Studies looking at cost savings from use of generic drugs "had mixed results regarding the effect of using these generics, in that some found they raised healthcare costs, while others found they led to cost savings," wrote the authors of a GAO report released Thursday.
The GAO report was requested by Sen. Orrin Hatch, co-author of the 1984 Hatch-Waxman Act, which paved the way for a major increase in the number of generic drugs. In the early 1980s, there were generic versions of just 35% of the top-selling drugs with expired patents; by the late 1990s, almost all of them had generic versions.
Prescription drug spending more than tripled from 2001 and topped $307 billion in 2010, making up 12% of all healthcare spending in the country, the GAO researchers wrote.
However, the growth has slowed markedly since the early 2000s when an increasing number of generic versions of brand-name drugs hit the market. On average, the retail price of a generic drug is 75% less than the retail price of its brand-name equivalent.
The report summarized the findings of peer-reviewed articles, government reports, and studies by national organizations -- including trade and nonprofit organizations -- on the cost effects of increased utilization of generic drugs.
The report authors identified three general groups of studies. The first group estimated the cost savings from relying more on generic drugs. One group of studies in that pool -- sponsored by the generic drug lobby -- estimated the use of generics to have saved the U.S. healthcare system $1 trillion from 1999 through 2010.
Another report, by the Congressional Budget Office (CBO), found that dispensing generic drugs rather than their brand-name counterparts reduced total Part D prescription drug costs in 2007 by about $33 billion.
A second group of reports focused on the potential to save even more through greater use of generics. For instance, the CBO estimated that if generics had always been substituted for brand-name drugs in Medicare Part D, $900 million would have been saved in 2007.
A third group of studies estimated the effect on healthcare costs of using certain generic drugs in cases where questions have been raised about how medically similar they are to the brand-name version. That group of studies compared the lower cost of the drug with the higher cost of increased hospitalizations from using a potentially less effective generic drug.
One study in that group found that depressed patients on selective serotonin reuptake inhibitors (SSRIs) who started on a brand-name SSRI and switched to a generic ended up experiencing an increase of $881 in total healthcare costs because of increased hospitalization rates and emergency department visits.
However, another study found those who began treatment on generic SSRI's had significantly lower costs than patients using brand-name antidepressants.
Another study in that group, done among renal transplant patients, found that total healthcare costs one year following transplantation were about $4,000 higher for patients who started therapy with generic immunosuppressants compared with those using brand-name drugs. That difference was attributed to "the cost associated with needing higher doses of the generic drug or additional immunosuppressants needed to maintain the transplanted kidney in patients using the generic," the report said.
Overall, the studies on whether generic drugs save money were a mixed bag, the GAO said.
Generic drugs must have the same active ingredients, route of administration, strength, and intended use as their brand-name counterparts. They also must be absorbed into the bloodstream at the same rate. Generic drugs are allowed to have different inactive ingredients, such as binding materials, dyes, preservatives, or flavoring agents compared with brand-name drugs.
At the end of the GAO report to Hatch, which was dated Jan. 31, the agency mentioned that it agreed not to publish the results of the report for 30 days. In the meantime, Hatch could have publicized the results, but did not. Requests for comment from Hatch's office did not bring a response.
Dear Colleagues,
I am thrilled to announce the permanent appointment of Elizabeth Dickinson as the Chief Counsel of the Food and Drug Administration, effective Monday, March 12, 2012.
As many of you know, Liz has had a long and distinguished history at the Agency; she joined the Office of the Chief Counsel in 1994. Over the years, Liz has served as legal counsel to the Center for Drug Evaluation and Research and the Office of the Commissioner on innovator and generic drug review issues, orphan drug development, and biosimilars; has implemented pediatric exclusivity and pediatric drug development programs; has worked closely with the Department of Justice on dozens of cases addressing Waxman-Hatch issues and preemption; and has coordinated the development of the Office of the Chief Counsel’s flexible workplace program.
A graduate of the University of Massachusetts and Northeastern University School of Law, Liz is highly regarded by both her internal colleagues and those across the food and drug bar. Over the years, Liz has received numerous awards for distinguished service, leadership and her outstanding legal skills.
Liz has been serving as Acting Chief Counsel since August 2011, and we have been grateful for her hard work and dedication each day that she has been on the job. It is terrific to know that she will be serving the Agency in this role permanently as we move forward. Please join me in congratulating Liz.
Sincerely,
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Two important stories from BioCentury:
FDA to hold hearing on biosimilars guidance
FDA will hold a public hearing on May 11 to discuss three recently published draft guidance documents on biosimilars. FDA said the hearing's purpose is to obtain public comment on the drafts, as well as receive input on topics to be included in the development of future biosimilar policies. The guidance documents, released early last month, indicate the agency hasn't settled some important biosimilars policy questions, including requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics.
EC seeks to reduce duration of reimbursement decisions
The European Commission proposed a Transparency Directive that would reduce the time limits for member states to make pricing and reimbursement decisions for medicinal products. States would be required to issue a decision within 120 days of approval for an innovative drug and within 30 days for a generic. Current regulations require a decision for all drugs within 180 days. Member states that review the relative efficacy of a product via a health technology assessment would still be subject to the 180-day limit.
Under the proposal, member states would be required to designate an enforcement body with the power to award damages and impose penalties for delayed pricing decisions. Member states would also be required to regularly report to the EC on the time required for individual pricing decisions. The new directive is slated to begin implementation in 2014. EC said pricing and reimbursement decisions can take as long as 700 days for new drugs and up to 250 days for generics. The EC began public consultation on the proposed changes last year.
On March 12th, the FDA’s Arthritis Advisory Committee will meet and discuss the anti-nerve growth factor (Anti-NGF), a drug class that is currently under clinical hold because of the threat of joint damage. Clinical trials for Pfizer’s tanezumab were suspended in 2010, at the FDA’s request, when some patients’ arthritis worsened to the point of needing joint replacement – and a class-wide clinical hold followed. (Similar treatments are in early stage development at Johnson & Johnson, Regeneron, Sanofi, Abbott, and AstraZeneca.
Anti-NGF therapies are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. And if the fact that, according to Professor Thomas Schnitzer of Northwestern University, “We’ve had over a hundred years without having a major new pain drug,” isn’t enough – Anti-NGF’s are non-opioids.
FDA has tasked the adcomm to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs and whether the risk/benefit balance for these drugs favors continued development as analgesics.
Why a clinical hold? While a Phase II, 450-patient proof-of-concept study showed that tanezumab relieved knee pain when compared to a placebo, a Phase III study (published in the New England Journal of Medicine) showed 16 patients experienced progressively worsening osteoarthritis associated with a form of bone damage known as necrosis, which required total joint replacements.
In an accompanying NEJM editorial, John Wood a researcher at University College, London and a visiting professor at Baylor College of Medicine (a post funded by Pfizer), wrote the joint failure “was most likely caused by excessive wear and tear in the absence of joint pain. Pain has an important role in the avoidance of self-harm, but chronic inflammatory pain has generally been considered to be wholly undesirable.” The tanezumab study “suggests that a complete quenching of pain in patients with osteoarthritis may not necessarily be a good thing.”
In other words, according to a report in the Wall Street Journal:
“Some researchers are suggesting that an experimental Pfizer drug may have liberated arthritis sufferers to such a degree that they became more physically active — and that the subsequent wear and tear on their joints led to joint replacement surgery.”
The drug made people feel “better than [they] ever felt before, and I have a feeling they just overused their joints,” Nancy Lane, a rheumatologist and bone-health specialist at UC Davis Health System in Sacramento. She suggests the drug could still play a role as long as doctors “counsel patients not to overuse their joints.”
What happens when a drug … works too well? Lane says she has seen this pain-masking situation before, including with the nonsteroidal anti-inflammatory drug (NSAID) indomethacin. “Because this is a new chapter in controlling pain, we didn’t realize we needed to counsel our patients in using their joints that were still diseased. Now we need to figure out how to use it so the risks don’t outweigh the benefits.”
And so the issue of patient education becomes crucial. What happens when a class of drugs is so effective, patients forget they have the underlying condition and behave contrary to their best medical interests? (In plain English – what happens when a therapy is so effective patients over do it and then suffer the consequences?) Hopefully the 3/12 adcomm will spend some quality time discussing this important social science question. Perhaps this issue should be taken up, um, jointly with the agency’s Risk Communications Advisory Committee? Anti-NGF drugs require not only a discussion of benefit/risk – but also the risk of benefit.
Those are, after all, precisely the kind of thorny scientific propositions FDA advisory committees are held to address.
Welcome to 21st century medicine.
Ladies and Gentlemen, start your engines.
Statin risks and benefits: People who take statin medications to lower cholesterol might also lower their risk of depression, a study suggests. That finding might cheer up patients who just learned that the Food and Drug Administration is adding new warnings about elevated blood sugar and memory loss to statin labels.
Epidemiology of this type is to science what Sparknotes is to writing a novel.
Kudos Kim!
http://yourlife.usatoday.com/health/healthyperspective/post/2012-02-29/concussions-in-kids-and-kobe-statin-risks-and-benefits-selenium-and-health-safe-airport-scanners-condoms-that-check-in/637023/1
According to news reports, Sonia Gandhi, the leader of India’s governing Indian National Congress Party, has left the subcontinent for a medical check-up. She made a similar departure from India in August.
Where is she? Thailand? Brazil? Pakistan? Turkey? Or one of the many other nations touting their medical tourism credentials? Top of that list, of course, is India.
We wish Mrs. Gandhi well and assume she is currently being treated in a nation that has an up-to-date pharmacopeia of innovative treatments. That list of countries, it is interesting and disturbing to note, does not include the above-mentioned locations.
Why report on such a study with blaring headlines and warnings and bury all the caveats at the end of the study?
Maybe someone who reads this blog can explain why medical journals publish such garbage and why reporters can't take 5 minutes to look at previous research on the subject?
http://abcnews.go.com/Health/Sleep/sleeping-pills-linked-times-increased-death-risk/story?id=15803687#.T00wPMzu6Uo
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.
