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...
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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?
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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.
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.CMPI President Peter Pitts interviews Former Governor George Pataki
No Refills - Magazine - The Atlantic
"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."
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.
