Latest Drugwonks' Blog
To watch our interview with Congressman Cassidy, click here:
blog.nj.com/njv_guest_blog/2011/03/losst_innovation_may_mean_lost.html
For those with life-threatening diseases or painful chronic conditions, time is not on their side. When promising treatments languish waiting for approval in a bog of bureaucracy, the cost must be reckoned in lost lives and diminished quality of life.
That’s why it’s so alarming that only 21 new drugs gained FDA approval last year. This was a significant decrease from the previous two years— there were 25 approvals in 2009 and 24 in 2008.
Not only are approvals down, so are applications for approval. This portends even further declines in annual approvals down the road. With science more cutting edge today and grants for new research — in areas from pediatrics to Alzheimer’s — at all-time highs, how is it possible that approvals and applications are both dropping?
The FDA’s review process, in the view of many in the medical and biopharmaceutical communities, has become increasingly turgid. The FDA now frequently calls for extra clinical trials, requiring detailed safety plans that necessitate additional doctor and patient education, and an extended review period.
Of the 21 drugs approved in 2010, there were 21 drug makers to take credit. Not a single company earned more than one approval. From Pfizer to Bristol-Myers Squibb to Eli Lilly to Merck — all of which were shut-out for approvals in 2010 — the FDA was an equal opportunity rejecter.
And the problem is not limited to medicines. The development of tools that tailor treatments to our individual needs are drowning in a sea of endless confusion. Tests and medical efforts that can help detect and prevent disease, and eliminate useless or even harmful care are being held up in the name of patient safety.
Government policy writ large has now begun to stifle innovation in pharmaceuticals. Obama’s health care plan levies tens of billions in taxes on new medical products through 2019. Comparative effectiveness studies, required even after FDA approval as a condition for being added to benefits, will delay progress, too.
Even worse is that FDA regulators are beginning to consider the comparative effectiveness of products and as a result are raising the bar for approval.
Sound far-fetched? It isn’t. Consider the case of $8,000-per-month Avastin, an anti-cancer wonder drug that blocks blood flow to tumors. In 2007, the FDA granted accelerated approval for the use of Avastin for treatment of metastatic breast cancer. It was clear from the Avastin studies then that while many women would not benefit from the drug, a significant minority could live longer and with less pain. The FDA asked Avastin researchers to evaluate the drug’s risks and benefits on a larger group of patients with the same standards used to approve the drug in the first place. The study confirmed the 2007 results showing benefit to specific groups of women. But the FDA revoked Avastin’s approval for breast cancer treatment because it didn’t extend life on average.
Innovation is the result, not of a top-down decision, but by learning from actually using an invention. Taking products off the market therefore undermines medical progress in many cases.
As a result of the FDA’s slow-to-act review process, the Obama health care plan’s disproportionate taxation of pharmaceutical firms and this recent Avastin decision, innovation is in a very precarious position. Most medical innovations come from start-ups with limited capital. For all the happy talk about supporting innovation and small businesses, the trifecta of government tactics is doing just the opposite. Just this month, Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, registered his concern: “The question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable.”
Meanwhile, China, India and Singapore are inviting America’s innovators to set up shop overseas. As the world’s leader — by far — in scientific research investment, the United States must change course and must do so immediately. Not only are we losing innovation, we are losing lives as well.
IMI Shelter
Europe's Innovative Medicines Initiative (IMI) launched eight new projects with a total budget of EUR 172 million ($240.7 million) under a five-year, EUR 2 billion program to relieve bottlenecks in drug discovery and development. The projects are focused on cancer, rheumatoid arthritis (RA) and infectious disease.
In 2009, IMI awarded EUR 246 million to 15 projects involved in improving safety prediction and pharmacovigilance; improving prediction of efficacy in diabetes and brain and respiratory disorders; and education and training in support of medicines development.
A third call for project proposals is under way and will focus on developing treatments for autism, tuberculosis and diabetes, as well as drug and vaccine safety. IMI is a joint undertaking by the EC and the European Federation of Pharmaceutical Industries and Associations (EFPIA) that is similar to FDA's Critical Path initiative.
NICE News
While we do not always agree with him, we are pleased to share the news that our friend and colleague Sir Michael Rawlins has been reappointed Chairman of NICE for an additional one-year term. Rawlins, whose new term runs through March 31, 2012, has served as chairman since the agency was established in 1999.
What Standards Will Apply To Federal Drug ‘Unsales’ Force?
Posted by Cory L. Andrews
Proponents of health care “reform” have invested an enormous amount of time and effort proclaiming how pharmaceutical company sales representatives (colloquially known as “detailers”) and their visits to medical professionals increase the cost of patient treatments and, in turn, health care in general.
For this reason, state and federal regulators have piled on laws and rules dictating what these detailers can and cannot say and do to educate physicians about their products. Some states, most prominently Pennsylvania, have programs where purportedly independent clinicians, pharmacists, and others pay visits to doctors to essentially counter what they hear from drug detailers.
This counter-detailing, or academic detailing, is now poised to move forward at the federal level as a way to circulate government-manufactured “comparative effectiveness” research funded by the 2010 Recovery Act and advanced in ObamaCare. The aim of comparative effectiveness is to reduce health care costs, an especially compelling goal for our government, the number one purchaser of medical treatments in America.
This fact begs the question: can academic detailers, paid by federal taxpayers and distributing federally-funded research be considered unbiased or neutral? And, if that is the case, what safeguards exist to ensure that this federal “unsales” force isn’t sacrificing the highest quality patient care in favor of saving money?
In fact, at this point, no such safeguards exist. Peter Pitts, a former FDA Associate Commissioner who is currently President of the Center for Medicine in the Public Interest, explores this question and puts forward many more important queries in a Washington Examiner op-ed, “What a Difference Two Words Can Make in Health Care.” Those questions include:
* “Will these studies be peer-reviewed before release?”
* “Who will decide what these detailers can say or not say? Will these government “reps” have to play by the same rules as their pharmaceutical counterparts?”
* “If academic detailers stray into off-label conversations, to whom does Food and Drug Administration send a letter?”
* “Who will determine the difference between “communicating” these findings and “promoting” them?”
These are all issues worthy of consideration by those who oversee federal implementation of the health care reform law.
In our interview with the Congressman, we focus on the health care law's impact on the practice of medicine in the long-term and plans by the House of Representatives this year to delay implementation of the law.
Watch the interview here:
As Disraeli said, “The most dangerous way to cross a chasm is in two leaps.”
Lengthy article in today’s edition of the Wall Street Journal (In Health Law, Rx for Trouble) focusing on the many (and immediate) unintended consequences of ObamaCare.
The article’s focus is on the law’s treatment of OTC medicines vis-à-vis flexible spending accounts.
It’s a very lengthy article. What follows are some pieces thereof that relate to the negative impact on physicians.
Sandy Chung is grappling with a new kind of request at her pediatrics office in Fairfax, Va.: prescriptions for aspirin and diaper-rash cream.
Patients are demanding doctors' orders for over-the-counter products because of a provision in the health-care overhaul that slipped past nearly everyone's radar. It says people who want a tax break to buy such items with what's known as flexible-spending accounts need to get a prescription first.
The result is that Americans are visiting their doctors before making a trip to the drugstore, hoping their physician will help them out by writing the prescription. The new requirements create not only an added burden for doctors, but also new complications for retailers and pharmacies.
"It drives up the cost of health care as opposed to reducing it," says Dr. Chung, who rejected much of a 10-item request from a mother of four that included pain relievers and children's cold medicine.
Though the new rules on over-the-counter drugs amount to a small part of the massive overhaul of the health-care system, the unintended side effects show how difficult it can be to predict how such game-changing legislation will play out in the real world.
Some doctors, irked by the paperwork and worried about lawsuits, are balking at writing the new prescriptions. Pharmacists and retailers say the changes mean they have to apply a personalized label on some 15,000 different everyday products for customers paying with certain debit cards.
Health-policy experts predicted that new insurance pools for high-risk patients would attract so many expensive enrollees that funding would be quickly exhausted. In fact, enrollment is running at just 6% of expectations, partly because of high premiums.
A provision preventing insurers from denying coverage to children with pre-existing health conditions prompted insurers in dozens of states to stop selling child-only policies altogether.
Only after the president's signature was dry did the American Medical Association realize what had happened and send a letter to the government warning of unintended consequences, including more office visits and extra paperwork.
Sure enough, when the change took effect Jan. 1, patients began bringing lists of over-the-counter drugs to office visits and also requesting over-the-counter prescriptions by phone, doctors says.
Among those most upset by the changes are pediatricians, who say that small sizes of children's medicines and multiple children per family make the requests particularly burdensome.
"It's an amazingly disruptive policy," says Jesse Hackell, a Pomona, N.Y., pediatrician who is charging $5 to fill such requests via phone. "I am now doing the IRS's work, and that's what I resent most."
After writing two over-the-counter prescriptions free of charge in January, pediatrician Richard Schwartz of Vienna, Va., says he began imposing a $10 surcharge for each prescription, on top of the office co-payment. That is likely to discourage some patients from asking for a prescription, as the surcharge could outweigh the tax savings from using a flexible-spending account.
Doctors are also concerned about malpractice lawsuits, since a prescription potentially puts them on the hook for any problems a patient suffers from over-the-counter drugs.
In the Nielsen survey, 37% of flexible-spending account users said they would ask their doctor about prescription drugs that could replace their over-the-counter medicines.
This is what happens when you look before you leap (translation – when you vote for a bill you have not read).
Watch the interview here:
In recent weeks many pundits and think tank types have raised questions about whether Governor Mitch Daniels is a 'real' conservative. Or more transparently put: there are many conservatives who don't agree with Daniels on specific issues and therefore categorize him as not conservative enough.
I won't go into pre-positioning around his so-call called for a truce on social issues. (He didn't say surrender or truce but a timeout and he suggested that the most immediate threat to our nation's future is the rocketing debt.)
And I will only note in passing that playing to most ideological elements of a party is par for the course of running for president.
My concern is the allegation that Daniels health care programs in Indiana is either creeping socialism or warmed over Medicaid. This argument is advanced by Michael Cannon’s article: “ Mitch Daniels’s Obamacare Problem: His state’s health-care plan promotes dependence on government.” www.nationalreview.com/articles/261285/mitch-daniels-s-obamacare-problem-michael-f-cannon
Cannon’s major claim is that under Daniels the number of people on Medicaid have increased and the creation of a program to provide health savings accounts for Hoosiers that cant afford insurance (and have not had it for 60 days) and do not qualify for Medicaid. The Healthy Indiana Plan is funded by a combination of Medicaid dollars and an increase in the state tobacco tax.
Cannon’s complaint is “Like Obama, Daniels increased cigarette taxes to expand government-run health care. Whereas Obamacare requires states to open their Medicaid programs to families of four earning $31,000 (138 percent of the federal poverty level), Daniels expanded Indiana’s Medicaid program to families of four earning $44,000 (200 percent of poverty). From 2008 to 2010, Indiana’s Medicaid enrollment spiked: Adult enrollments grew 21 percent, a rate nearly double the national average. By 2010, Daniels had enrolled another 62,000 Hoosiers in government-run health care. “
First, Cannon should get his facts straight. Indiana’s adult Medicaid enrollment increased 17 percent from 2008-2010, slightly higher than the national average of 14. 6 percent. And between 2009-2010 the rate of increase in Indiana's adult Medicaid enrollment declined (as it did in only 16 other states) and did so more dramatically than most. Second, Cannon cites Indiana’s income eligibility levels for families when he should have cited the income levels for adults. But that would undermine his argument since Indiana caps eligibility at 50 percent of poverty.
Cannon believes Daniels ultimate sin is that he “made Medicaid more attractive: Under his plan, the government hands out coverage plus something a lot like cash.”
Do Cannon and other Daniels denialists regard the governor’s proposal to convert public education funding into a statewide school voucher program an example of making “public education” more attractive by handing out coverage and cash. Cannon dismisses the shift in personal responsibility, the creation of competition, the cost savings and the qualitative differences that vouchers and health savings accounts bring.
Daniels can push such a change because he has control over state funding of schools. As of now, Daniels and other governors that would want to turn Medicaid into a voucher program must wait years and face a hostile Obama administration.
I know Cannon works for the Cato Institute and is therefore more likely to object to any expansion in government. But governing is not ideology. And policy disagreements should be based on facts.
And facts matter. And the facts show that Indiana's Medicaid population did not double compared to the national average. Healthy Indiana has enrolled the most chronically ill and chronically un-insured Hoosiers since 2006. Over that time costs have stabilized and not exploded. Those who have found jobs don’t forfeit the coverage they have. They can keep it, along with the health savings accounts they have created. Which might be one reason that Indiana has more business startups than other states and its workforce and population has increased.
CMPI believes in and supports patient-centered, portable and affordable health care coverage. We don't accept the status quo. We believe we can do better but that Obamacare is an obstacle to innovations in medicine, technology and funding that are essential to improving the healthcare system. That doesn't mean some features of the law shouldn't be preserved. It means that to preserve them will likely mean repeal takes the form of substantial reform.
That's an honest difference of opinion that we are welcome to debate and discuss anytime.
So when MM responds to our interview with Michele Bachmann (See the Media Matters response and the video at politicalcorrection.org/blog/201103040003 ) by first accusing us of being paid to be part of a "front" to kill healthcare reform it suggests that Media Matters is more interested in silencing CMPI rather than engaging in debate. It would be easy to respond by pointing out that MM's funding is from George Soros, whose non-profit empire could be considered a "front" of sorts.
Conflict of interest is a canard that cuts both ways. It scores points and generates heat but little light.
It's fine for MM to take issue with Congresswoman Bachmann and CMPI's interest in her views. However it seems that Media Matters is more interested in repeating talking points than in substantive discussion.
I will debate or discuss Obamacare with anyone from Media Matters or ThinkProgress any time or any place. But I don't think they will take up the challenge. They seem too obsessed with reassuring themselves that the rejection of Obamacare is the result of a well-financed campaign to lie about how wonderful the new healthcare law is.
If and when Media Matters and ThinkProgress snaps out of that disassociative state, I will be happy to engage them.
The proposition of the FDA’s “Safe Use” initiative is that the way to make a drug “safer” is to better educate prescriber, dispenser, and user about the product.
At a meeting of the FDA’s Risk Communications Advisory Committee (February 26-27, 2009), there was open public comment on the issue of how to improve the written information currently provided to patients about the medicines they receive (aka “consumer medical information” or “CMI).
(PS/ per full disclosure, while I did not participate in this meeting I am a Special Government Employee consultant to this advisory committee.)
The meetings complete comments can be found here.
I found the remarks of Pam Budny, a regulatory affairs manager at Eli Lilly of particular interest.
Some extracts from her comments:
Patients should be able to locate, interpret, and act upon information in written patient labeling. It should facilitate or reinforce the communication between the patient and the prescribing and/or dispensing healthcare professional.
Patient labeling should be prepared by the sponsor just as is the case for physician labeling. Physician and patient labeling are inextricably linked in terms of the information they contain on benefits and risks.Sponsor-prepared patient labeling ensures consistency of information provided to patients in multiple venues.
For example, patient labeling received at the time the medication is dispensed would have the same content as the “full disclosure” accompanying promotional materials for patients.
Testing with patients and or caregivers prior to submission is a critical way to determine the usefulness of patient labeling prior to patient use.
Patient labeling should be developed by sponsors, tested with patients, approved by FDA, and delivered in ways that are compatible with pharmacy dispensing workflows. This information should be made available to patients each time they receive their medication.
These comments reinforce the concept of a sponsor-developed, FDA approved, “label detailing guide.” Assuming that healthcare providers both read and understand the PI is, well – wrong.
Consider the report out of the University of Chicago (a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008) indicates there is confusion among physicans about what is or is not “on-label.”
According to the abstract, the average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA-approved and greater evidence supporting efficacy for that use.
The study’s senior author, Dr. G. Caleb Alexander (assistant professor of medicine at the University of Chicago) said a concern was that off-label uses often did not have the same level of scientific scrutiny as FDA-approved uses.
All the more reason for the FDA and the pharmaceutical industry to jointly develop (as part of the agency's Safe Use initiative) better ways to make the PI more user-friendly.
The time for sponsor-created and FDA-approved label “detailing aids” is now.
“Sometimes the questions are complicated and the answers are simple.
Dr. Seuss
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.
