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However rumor has it that Rosa DeLauro, who has been stonewalling on the funding for the Reagan Udall Critical Path Institute, has been asked to write the transition plan for the Department of HHS by the Obama camp. I can only imagine what that has in store for FDA given her Stone Age view of "Industry involvement = biomarkers = unsafe drugs".
As for names floating around to replace Andy von Eschenbach....How does FDA Commissioner David Graham sound? When I heard this from a contact who told me that Graham was mentioned not once but three times, I nearly choked on my supply of Vioxx. A Graham nomination would trigger mass resignations and protests at FDA and would send a signal that Obama or whoever he appointed at HHS was clearly in the pocket of the trial attorneys and drug safety nuts....
And speaking of suck-ups in pursuit of power...
Airdate: 10/1 - Health care policies
11AM Case Western University Cardiovascular Medicine Chair Dr. Steven Nissen, M.D. for Obama-Biden
Nissen has also given Obama about $3300 in campaign contributions in 2008
From Factcheck.org
In a TV ad and in speeches, Obama is making bogus claims that McCain plans to cut $880 billion from Medicare spending and to reduce benefits.
- A TV spot says McCain's plan requires "cuts in benefits, eligibility or both."
- Obama said in a speech that McCain plans "cuts" that would force seniors to "pay more for your drugs, receive fewer services, and get lower quality care."
- Update, Oct. 21: A second Obama ad claims that McCain’s plan would bring about a 22 percent cut in benefits, “higher premiums and co-pays," and more expensive prescription drugs.
http://www.factcheck.org/elections-2008/obamas_false_medicare_claim.html
The media continues -- with help from "watchdog" groups -- continues to characterize drugs as dangerous by confusing association with cause:
Prescription drug injuries and deaths reach record levels
Those numbers represent a nearly threefold increase in deaths from the previous quarter and a 38% increase in injuries from last year's quarterly average, according to the Horsham, Pa.-based Institute for Safe Medication Practices.
http://www.latimes.com/news/nationworld/nation/la-sci-drugs23-2008oct23,0,3729962.story
Are drugs three times more dangerous? Are we picking up more danger and death that is being attributed to other causes?
None of the above.
Here's a more likely answer provided by the authors of the ISMP study who happen to be well known industry and FDA critics.
"Most drugs in medical use produced only a small number of reports of serious
injury or death. One-half the 773 identifiable drugs tracked in the most recent
quarter had six or fewer serious adverse events reported. Only 50 drugs accounted
for 100 or more reported serious injuries."
http://www.ismp.org/
The newest drugs, the one's that are most likely reported in the media in other words or to be likely targets of lawsuits.
At the same it would appear prudent for companies who are launching new products or new uses to proactively seek out the response of consumers and integrate those responses into other pharmacovigilance activities as soon as possible. Studies show that doing so allow companies to identify and test signals earlier than would otherwise be the case.
- Expert Opin Drug Saf. 2007 Nov;6(6):705-12.Effect of consumer reporting on signal detection: using disproportionality analysis
One such consumer-centered source of information is http://iguard.org/
Better to go right to the source rather than to be "sourced" by sources that don't have your interest or the consumer's real interest in mind. That goes for health care policy and drug safety.
Here's a link to the agenda.
A few thoughts in advance.
Many have looked at the FDAAA language on REMS and seen it as an ill-advised green light for the FDA to inject itself into the practice of medicine.
While I agree that REMS does indeed represent an expansion of the FDA's mission, I do not agree that it is ill advised. REMS is the responsible extension of the FDA's mission of safety and efficacy into the new realm of safe use. As previously discussed in this space ("A Potent FDA Double Feature") the FDA's role in educating both patients and providers on the safe use of approved therapies is a logical and approprite third leg of the agency's mission.
The first real move into this space was the FDA's change in the warfarin label. As Dr. Caroline Wright (Foundation for Genomics and Population Health) wrote:
“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug, the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.
Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.
The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.
FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicine."
It's important to note that when the FDA announced the warfarin label change the agency (and Larry Lesko in particular) came under attack from critics who asserted that this was the FDA, inappropriately, telling doctors how to practice medicine.
What some see as mission creep, others see as responsibility in our new age of more precise diagnostics.
The concept of "safe use" as an integral part of the FDA's 21st century mission and the REMS concept (as refined via FDAAA) as one of many tactics to achieve better patient care is contentious.
And crucial.
But what do the numbers really say?
"However, the Rochester team found that kids from families with annual incomes at 200 percent to 400 percent of the poverty level ($38,000 to $76,000) are now just as likely to be uninsured as children from poorer families. "
76K and you can't or won't add your kid to your health plan? In NJ, the cost of adding two kids to your individual HMO health plan (and this is the most expensive place in the nation to do so) is $400 a month. Not cheap but still....
Moreover, why can't we provide middle class Americans, single parents, kids starting out, with less expensive health care coverage. Am I missing something? Why not a monthly fee of $100 to cover primary care, prescription drugs and catastrophic health care costs?
Read article here
At least that was the point I made at a debate I participated in at Columbia University Medical Center on which health care proposal was better for America: McCain's or Obama's?
According to a report by the Lewin Group, the Obama plan -- which seeks to preserve employer based insurance -- does so by shoving about 52 million Americans into publicly funded health plans. It pays for that transition by cutting the reimbursement of doctors by at least 25 percent compared to what they get from private insurers, raising about $300 billion in taxes and cutting insurance premiums through price controls. I ignore the estimated savings from health IT and disease management because it's all based on articles published by people like me.
In essence, the Obama plan is preserving the tax exclusion for employer based insurance, which favors the rich. As the Center for Health Transformation's Jim Frogue noted several years ago: "Under the current tax code, workers whose employers contribute to their health coverage have that amount excluded from income and payroll taxes. Most employees are not aware of this (which is why Obama is able to portray the McCain health plan as a tax increase). Yet it amounts to a significant and, incidentally, highly regressive tax break--the higher one's tax bracket, the bigger the subsidy. According to the Lewin Group, a leading econometrics consulting firm, families earning $100,000 per year average $2,638 in tax subsides, but those under $15,000 get an average subsidy of only $79."
http://www.heritage.org/research/healthcare/EM740.cfm
26 million Americans will get private coverage under the McCain plan and 12 million of those will be able to shop for health insurance that is cheaper than the $12000 a year policy Obama and Biden believes is the "right" amount of coverage. And that coverage will be available with guaranteed issue conditions but shorn of expensive mandates that many people who are indifferent to risk but price sensitive do not want.
Under the McCain plan, as I noted, the amount employers contribute will be counted as wages and will be taxed at the marginal tax rate as Obama notes. But it will also, as the Lewin study notes, lead to an increase in wages and overall greater tax subsidies overall at every tax bracket with most of the tax subsidies going to Americans in the lowest income brackets. Of course, those in the higher brackets will be able to bank increased wages in tax free HSAs, IRAs ,etc. to offset tax liability.
And under the Obama plan Dan the Doctor will get paid less, pay more taxes and get sued more often and more successfully. Under McCain, doctors will be able to compete and serve patients directly outside of government controls.
I think there is considerable openness to other approaches to making health care convenient and affordable in both camps. At least I hope so. Because the effort to herd people into a glorified version of SCHIP or Medicaid -- or simply giving everyone an HSA -- will fail.
http://www.cbo.gov/doc.cfm?index=9887
Let's take a step back.
In his powerpoint presentation Orszag has a slide stating:
"As we seek to improve the efficiency of the health sector, let’s learn some lessons from economics."
He shows some slides that automatic enrollment in 401Ks leads to higher participation in 401k plans than when it's voluntary. As if that's an earth shattering discovery.
Then a slide purporting to show that the placebo effect is almost as strong as antidepressants, angina pectoris treatment, knee surgery and exercise.
Then a slide showing that once a day dosing and frequent doctor-patient interventions increase compliance with medication regimens
What are we to derive from this?
I think Orszag is trying to underscore the importance of psychological and behavioral differences in determining responses to treatment, not that placebos are better.
That is, individual responses have to be taken into account to maximize value and improve outcomes. Establishing who is risk averse and why is part of this process. So too is genetic response to medicine. All are important.
That is, measuring the personal is critical to comparative effectiveness. Finding ways to promote patient-centered care is crucial. More to the point, perhaps Orszag is seeking to drive comparative effectiveness towards value-based medicine based on personalized health care information which in turn is generated by a critical path for comparative effectiveness.
Thank you Dr. Orszag.
The always savvy Jim Edwards has a thoughtful and important article in this week’s edition of BrandWeek. Its title, “Why Pharma Fears Social Networking,” says it all.
Jim continues, “Marketers fear that user-generated content will include complaints about injuries caused by their drugs’ side effects. The law requires these “adverse events” to be reported to the FDA. The FDA’s adverse-event databases are regularly combed by lawyers looking for potential class-action suits. Thus, drug marketers have stuck with a decidedly Web 1.0 model, in which customer interaction is kept to an absolute minimum.”
But Edwards believes that, “This head-in-the-sand approach may be about to change. A debate is raging in the drug business as to whether companies should adopt a Web 2.0 strategy. On one side are digital agencies telling companies that online customers generate far fewer adverse event reports than drug companies might expect. On the other side are brand managers, whose every published word must survive a thicket of in-house lawyers, some of whom aren’t Internet savvy. The pressure for drug companies to evolve is growing.”
There are legal issues – and they’re important. There are marketing opportunities – and they’re exciting. But what really matters is that social media is a terrific opportunity to help educate the various constituencies of American healthcare about all sorts of important issues. Safety? Sure. But also safe use, compliance/adherence, and a host of others.
If safety is important (and it is very important), then pharmaceutical companies should seek out (rather than side-step) ways to uncover legitimate adverse events. By not engaging in 21st century digital expiscatoriation, industry leaves the FDA with little choice but to pursue its own well meaning (if questionably designed) communications vis-à-vis early safety signals. Silence is leaden. The obvious lines between social media and traditional DTC are obvious and will be used by legislators and pundits intent on hoisting the industry with its own petard. Pharma must lead, follow, or get out of the way. Complaining is not an option.
And neither is avoidance.
According to Dr. Janet Woodcock, “FDA does not control the health care system, so our improving the use of marketed drugs, to a great extent, is going to involve influence rather than control,” by partnering with the growing patient safety movement, she said. “The vast majority of harm from approved drugs comes from misuse, inappropriate use … failure to use, abuse and medical mix-ups. There is just carnage out there, and we know that.”
“Influence rather than control” is a savvy and sophisticated concept -- one that many of our elected members of Congress could learn from.
This new "Safe Use" initiative is the patient-facing sibling of the agency’s “Safety First” pharmacovigilance progam. But it's more than that -- it's the FDA reasserting ownership of safety from those who would use it only as a malllet of fear.
And it’s a potent double feature.
EDITORIAL: The FDA and junk science
Monday, October 20, 2008
There are many good reasons for the Supreme Court to uphold the authority of the Food and Drug Administration in determining what information should be included on the label describing the risks and benefits of a drug. A current case would challenge that authority, known as pre-emption, and hand it over to trial attorneys suing drug companies that, as part of any financial settlement, would be able to demand changes to the information a company would have to provide doctors and consumers.
Today's Op-Ed by Tomas Philipson notes that vaccine investment dried up after litigation costs in the wake of a successful lawsuit. But higher prices are not the only result of overturning pre-emption. Nor are they the most costly. The litigation that found pertussis vaccines "caused" Sudden Infant Death Syndrome was conducted without any scientific basis for such a link. This has spurred a whole industry of trial attorneys and doctors on the take who have been willing to concoct the conspiracy that vaccines or their ingredients "cause" autism or other brain damage. That in turn has allowed science to be hijacked in favor of what one observer has called "judgments based on anecdotes and speculation."
That observer was Marcia Angell, who, more than a decade ago, saw how fearmongering fed by courtroom antics and junk science shoved aside the FDA and caused a panic among women regarding silicon breast implants. It was a panic, as Dr. Angell noted back then, that had "no good scientific evidence for or against a link between breast implants and systemic disease of any kind."
Today, it is even easier to supplant science and replace it with a state of fear. Fake blogs, journalists working closely with trial attorneys, and doctors and scientists on tort-lawyer payrolls create and spread specious theories and crank out statistical associations without any real evidence of cause and effect. Panic spreads and is reinforced in court-proceedings. As one theory is knocked down, such as the measles vaccine causing autism, another one - thimerosal - springs up.
And you only need one "study" to cause panic and launch a class-action lawsuit. (That and the visceral hatred of corporations Dr. Angell once found to be flimsy basis for silicon-breast-implant litigation.) But now Dr. Angell claims that the courts are the only avenue to establish the real risks of a drug because the FDA is merely a rubber stamp for drug companies. Forget the fact that the number of drug approvals have declined in the past few years and the number of late-stage drug flops has increased. So much for evidence.
Dr. Angell and the current editors of leading medical journals are willing to allow the trial bar to displace the FDA. This group is willing to forfeit the ability to target risk and benefit - where science is heading - and permit opinion and emotion to hold sway. As Dr. Angell noted, in the courtroom, the experts' opinions are the evidence. It would seem now that Dr. Angell and others have drug companies in their sights, their opinion (and overturning pre-emption) is all that matters.
I hope and pray it works for his sake and everyone else's suffering with the disease including my boyhood friend's mom who has gone through every other drug for the disease but who has now relapsed.
"Biogen Idec is running an early-stage trial of the drug in multiple myeloma, but Baron doesn’t meet the criteria to participate.
Baron’s a prominent donor to the Democratic party, and many of his powerful friends, including Lance Armstrong and Bill Clinton, made appeals on his behalf. And the family agreed not to sue if anything goes wrong."
Gee, why didn't he think of that when it came to Celebrex which generated billions for Pfizer and also had anti-cancer properties that were being studied until Baron's tactics were deployed in lawsuits against the the product: Ironically, Tysabri was yanked from the market in the wake of the Vioxx withdrawal...
Pfizer, the world's biggest drugmaker, has reached a settlement in thousands of cases involving two prescription painkillers." The company announced Friday that "it had agreed to set aside $894 million to settle virtually all the lawsuits related to its withdrawn painkiller Bextra (valdecoxib) as well as a similar drug that remains on the market, Celebrex (celecoxib)," the New York Times (10/18, B2, Saul) added. The agreement "comes approximately one year after Merck announced a $4.85 billion reserve to settle litigation involving the similar painkiller Vioxx (rofecoxib)."
In 2004, Celebrex and Vioxx, "part of a class of drugs called Cox-2 inhibitors," were found "to increase the risk of heart attacks and strokes, especially in patients who took them steadily over long periods of time," the Los Angeles Times (10/20, Healy) notes. And, despite several trials that have shown that Celebrex may "offer a real prospect of preventing cancer," Pfizer "called off a number of clinical trials...and abandoned efforts to have the drug's cancer-prevention qualities recognized by the Food and Drug Administration" after "Vioxx was withdrawn from the market."
Note the amount of cash Pfizer had to fork over to various special interests in a decision that had nothing to do with with real risks of the drug, including the Prescription Access Litigation Project which is a limited liability corporation that funds and reports directly to Community Catalyst which also runs The Prescription Project.
"The Pfizer agreements...came after several pre-trial court rulings in the company's favor," according to Amy Schulman, Pfizer's general counsel. In one case, a district judge "who oversaw the federal cases in San Francisco" ruled that "there was insufficient scientific evidence that Celebrex caused heart attacks or strokes at the 200-milligram dose."
There is a certain degree of chutzpah requried to push for the off-label use of a drug to save your life when you have made millions perfecting a strategy employed by an organization that launches lawsuits based on the principle that off-label prescribing is inherently deceptive. I have to say I admire it and would do anything to keep living as well. As I said at the outset, I hope Baron responds and lives a long and healthy life. As for the Prescription Shakedown Project...that's another matter entirely...
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.
