Latest Drugwonks' Blog
Yesterday the Council on Foreign Relations held a conference on the issue of global counterfeiting of both food and drugs. Appropriately, the U.S. Commissioner of the Food & Drug Administration, Peggy Hamburg, was the keynote. And she had some interesting and important things to say.
A few pearls from Peggy:
* The new reality of food and drug regulation is that it’s global. In fact, it should be a topic for conversation at the next meeting of the G20.
* The recent crises in both food and drug safety will only repeat themselves unless regulatory agencies from around the world work in closer and more regular partnership.
* There is a responsibility on the part of the FDA and other more developed regulatory agencies around the world. (MHRA certainly comes to mind.) to help build “regulatory capacity” for those nation’s that want and need assistance. (Nigeria comes to mind.
* Part of a closer working relationship means a more regular and robust sharing of global intelligence on issues of counterfeiting. (And, for that matter – many other things too.)
* And lastly, “We can’t inspect our way out of this problem."
All good things – progressive things -- but, short of a regulatory Marshall Plan, things that will have to rely (at least initially) on personal relationships between senior officials at various regulatory agencies and a focus on what’s best for global public health writ large is convergent with what’s best for any given nation.
It’s not as easy as it sounds.
Beyond the generally difficult nature of international regulatory harmonization (yes friends, it is a lot harder than it looks) is the profoundly difficult issue of domestic economic interests and trade.
For example, every nation (from the United States to Nigeria) is concerned about counterfeit drugs and unsafe food coming across its borders. That’s obvious. But are all nations equally concerned about controlling the export of counterfeit, unsafe, and substandard products to other nations? That’s trade.
Principles aren’t principles, as my father used to say, until they hurt.
Paul Orhii, Director-General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), was on the event’s first panel and he shared a chilling story – not of children dying from imported Chinese cough syrup laced with diethylene glycol, but of the Chinese government’s view on where it’s responsibility for quality control begins and ends.
The Chinese, it seems, believe their responsibilities end when a product leaves the borders of the Middle Kingdom.
According to Orhii, when he complained to the SFDA (the Chinese drug regulatory agency) that many of the counterfeit medicines in Nigeria (where, according to the NAFDAC DG, 40% of the drug supply is counterfeit) were coming from China, he was bluntly told that Beijing was not responsible for the quality of medicines in Nigeria – that was his problem.
So much for regulatory fraternity.
And, when it comes to counterfeit medicines there’s the definitional problem – largely driven by (yep) domestic and international trade concerns. You can talk TRIPS all day long, but at the end of the day it’s about money.
If we can’t even agree on the definition of “counterfeit medicines,” how are we ever going to start, methodically and cross-nationally, measuring its size and scope? And while the war of words rages within the Byzantine confines of the WHO, people continue to die and the problem continues to grow.
As a next step, how about a coordinated international effort to measure the infiltration of counterfeit medicines into national drug supplies. After all, if you can’t measure it, then it doesn’t really count.
We cannot continue to combat counterfeit medicines through the power of horrific anecdotes.
“Man is the measure of all things.”
-- Protagoras
We should all pay attention to our nomenclature. It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.” And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.
When it comes to “transparency,” we need to weigh “interest versus benefit." Case in point: so-called “academic detailing” (AD).
According to the Big Daddy of AD, Jerry Avorn (Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology ), “Academic detailing is when healthcare professionals (usually pharmacists) meet with healthcare professionals to provide them with information and educational tools on various treatment options and optimal care, to improve provider knowledge of medical treatment effectiveness, encouraging alignment of practices with established evidence.”
(PS/ for the sake of transparency, it’s important to note that Dr. Avorn has his own for-profit academic detailing business that has a contract with the state of Pennsylvania.)
Left unsaid, but clearly implicit, is that such detailing is required to offset the devilish doings of the pharmaceutical industry. That’s why the more common appellation for academic detailing is counter detailing.
Why should anyone care? Well – not to put too fine a point on it – it’s now the law of the land. (That is to say that significant government funding has been provided to develop and roll-out academic detailing programs.)
As of October 2010, AHRQ has awarded five grants for a program on academic detailing and the “communication of CER results to physicians”. This program to disseminate CER findings is supported by $29.5 million from the American Recovery and Reinvestment Act (aka, “the stimulus package”).
Where is the money going? Good question.
* One contract, for $11.7 million, went to Total Therapeutic Management (TTM) and is specifically intended for physician outreach and education
(TTM is a company that focuses on chart abstraction, data mining, and physician and patient education for a predominantly commercial client base -- health plans, pharmacy benefit managers, employers, and pharmaceutical companies, etc.)
The goal of this contract is to integrate AHRQ’s comparative effectiveness research, products, and tools into clinical practice through 9,000 on-site, face-to-face visits with clinicians, nurses, health plan formularies, benefit managers, and other healthcare professionals.
Other recipient organizations under the overall program:
* $18 million to Ogilvy Public Relations Worldwide, Healthcare Division to create a publicity center and another contract for $8.6 to create regional dissemination centers.
* A $4 million “continuing education award” to Prime Education (an educational design and accreditation company focused on continuing medical education programs).
* $2.4 million to IMPAQ International (a social science research and consulting firm that specializes in impact evaluations for a client base of predominantly U.S. government agencies) to evaluate the impact of the other four contracts.
But there are some problems.
* Only a few small studies demonstrate that academic detailing reduces overall healthcare costs (direct and/or indirect) – and most only demonstrate reduced prescription drug expenditures.
To that point:
* Reducing the amount of money spent on drugs without improving the quality of care significantly limits the impact of detailing programs on overall healthcare costs. In fact, it just reinforces the concept of “fail first” – a strategy that’s good for payers (including our nation’s biggest payer – Uncle Sam) – but bad for patient outcomes.
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 out-of-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.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.
One study of schizophrenia drugs used in Georgia's Medicaid program showed that, while step therapy saved the state close to $20 a month on drugs for every patient, the savings were more than offset by increased costs in other services. Indeed, the program saw a monthly increase of nearly $32 per patient in outpatient care.
As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted, "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost." Access to care must be matched with quality of care.
There is little information on why so few AD programs attempt to measure overall healthcare cost reductions. This is likely due to the fact that measuring changes in prescription drug costs is a more manageable analysis than determining changes in overall healthcare spending. It also (in the calling a spade a spade department) fits into the general cognitive mapping of those who believe that pharmaceutical costs are the main driver of health care costs. (FYI – on-patent drug costs represent less than a dime on the American healthcare dollar.)
If the goal is better outcomes and lower costs – the problem isn’t the cost of pharmaceuticals, it’s the costs of non-compliance.
The New England Healthcare Institute estimates that $290 billion in healthcare expenditures could be avoided if medication adherence were improved.
A new study in Health Affairs demonstrates that people with four common chronic illnesses saved themselves – and the healthcare system – significant dollars by being medication adherent.
The CVS Caremark-funded report is based on an analysis of 135,000 patients with congestive heart failure, diabetes, hypertension and high cholesterol. The study found that people who took their meds made fewer visits to the emergency room and spent fewer days in the hospital. Specifically:
* Patients with congestive heart failure who took all their prescribed drugs saved $7,832 per year compared with those who didn’t.
* Patients with diabetes saved $3,756 by taking all of their meds.
* Patients with high blood pressure saved $3,908 when they filled all their prescriptions.
* Patients with high cholesterol saved $1,258 when they got the full benefit of pharmaceuticals.
The study concludes:
“Our findings indicate that programs to improve medication adherence are worth consideration by insurers, government payers, and patients, as long as intervention costs do not exceed the estimated health care cost savings.”And according to a report from the Center for Technology and Aging (CTA), "Medication non-adherence is responsible for up to 33 percent to 69 percent of medication-related hospital admissions and 23 percent of all nursing home admissions."
Adding new meaning to the words "penny wise, pound foolish."
The CTA recommends a robust program of medical optimization (“med-ops”) via information technology as an important element to improving medication-related errors and improving medication adherence among older adults.
The report says "widespread use" of technology aimed at this population could save thousands of lives and billions of dollars.
"More widespread use of technologies that reduce the cost and burden of medication-related illness among older adults is urgently needed," said David Lindeman, the center's director.
AHRQ funding for such programs: zero.
The worst part about rushing headlong into academic detailing is that there is no clear articulation or transparency regarding the specific rules and regulations that will govern the behavior and activities of AHRQ-funded detailers.
Some of those unanswered (and, alas, unasked) questions:
Q: What safe guards are in place to certify that physicians are being presented information that is unbiased? Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low cost therapies.
Asked another way – how can an “academic detailing” program funded by our nation’s largest payer be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent. But “academic” it ain’t.
Q: What information is worthy of being detailed by these programs? Who decides and on what basis?
Q: What can they say or not say? Who decides? Will they have to play by the same rules as pharmaceutical representatives? And, importantly, what is the oversight mechanism? If academic detailers stray into off-label conversations, to whom does DDMAC send a letter? Whom does the Department of Justice investigate? Who pays the fine?
All this to say that, if academic detailing is the answer – what’s the question?
While CBS is cancelling Two and Half Men while Charlie Sheen enters rehab, it is still sticking with Andrew Wakefield. Specifically CBS Evening News producer Sharyl Attkison – who works for Katie Couric – continues to carry on the anti-vaccine crusade of Andrew Wakefield and others who believe that Wakefield is a misunderstood martyr. Atkinson, who in the past sought to smear Paul Offit and other scientists for promoting the safety and importance of immunizations remains Wakefield’s staunchest support among the mainstream media outlets. After Wakefield’s fraud was exposed and many journalists began to acknowledge that they had provided him and anti-vaccine groups with an “evidence free pass” over the past decade, CBS News came out with this fearmongering headline:
Child Flu Vaccine Seizures?
More confusing news for parents trying to do the best, safest things for their children when it comes to vaccination.
According to a Vaccine Safety "update" issued by the FDA on Jan. 20, there's been an increase in reports of febrile seizures among infants and children following this year's flu vaccine. Febrile seizures are seizures associated with fever.
According to the FDA: "FDA and CDC have recently detected an increase in the number of reports to VAERS of febrile seizures following vaccination with Fluzone (trivalent inactivated influenza vaccine or TIV, manufactured by Sanofi Pasteur, Inc.). Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age."
The FDA says 42 more seizures than usual were reported through Dec. 13; most within a day of the child receiving the flu vaccine. The FDA recommends parents take no action based on this information. They should, the FDA says, continue getting their children vaccinated against flu, as usual. (It should be noted that non-government medical experts differ on the issue of whether flu shots should be given to children.
The FDA points out that data from VAERS, the Vaccine Adverse Event Reporting System, is preliminary and serves as a sign that further investigation is warranted. The maker of the flu vaccine in question, Sanofi Pasteur, has issued a statement saying that no clear link has been established between the flu shot and the seizures, and the cases may be nothing more than coincidence.
And CBS concludes:
Even with "no clear link established," the mere suggestion of a link may be troubling to parents.
Not content to stop there, CBS adds a link to another study that has nothing to do with flu shots:
http://www.cbsnews.com/htdocs/pdf/Molecula.pdf
But the study says nothing about kids, vaccines, seizures, autism.. The study merely points out that in animals early life seizures can result in cellular and molecular changes that could contribute to learning and behavioral disabilit
As the LeftBrainRightBrain blog (points out): “Attkisson has either not read the study she cites, does not understand it, or has a very dark agenda. The paper discusses patients with early life seizures and epilepsy. Attkisson gloms on to the findings and applies them, with no credible reason, to the general population.
The 42 extra cases of febrile seizure reported in the VAERS database do not come close to establishing causality. Instead of telling readers the FDA report is no cause for alarm, Attkisson does the exact opposite.
And Attkisson has been a stalwart in using CBS News to flack for and support anti-vaccine causes:
http://lizditz.typepad.com/i_speak_of_dreams/2008/07/sharyl-attkisso.html
Where are the health care journalists and watchdog types when it comes to CBS News as a platform for anti-vaccine rhetoric? It’s time to demand that CBS both explain this troubling pattern and seek to ensure it’s coverage of vaccine safety issues – as well as other medical news – is science-based.
It should worry about the lives of kids more than it does the future of one of it’s sit-coms.
As the saying goes, the plural of “anecdote” isn’t “data” -- that is unless the anecdote supports your theory. Here’s a personal anecdote -- a story of how the system works.
Being adopted, I have no family history, so when I suffered through some late night chest pains I figured I’d better act on the warning signals. I called my GP and got a same-day consultation, resulting in a next-day referral to a cardiologist and a stress test. Diagnosis – arterial blockage and an immediate referral to NYU Medical Center for an angiogram. 48 hours later I had two stents and was home – writing this report.
My situation is not unique but, being in the business of healthcare policy, some of the things that happened to me are indicative of some broader themes.
1. Facts vs. Fear
After being admitted into the cardiac unit, getting my wrist ID and giving some blood, my first visit was with a nurse practitioner who began her explanation of stents as follows, “You might have read some newspaper articles about how stents are over-used and dangerous. That’s crap. They save lives, they’re safe and it’s a lot more pleasant than open-heart surgery.”
This before she asked me what I did for a living.
2. The Evils of Pharmaceuticals
After the obligatory (and important!) lecture about the need to eat more healthfully and exercise more regularly, one of the resident’s said to me, “And we’re big believers in pharmaceutical intervention – don’t believe everything you read in the newspaper.”
This before he asked me what I did for a living.
3. Problems with the FDA
When I told the interventional cardiologist that I was a former FDA associate commissioner and was at the agency when the first drug eluting stent was approved, his comment was, “That’s something you should be proud of.”
That, despite all the middle-of-the-night poking and prodding (and my roommate’s bed-rattling basso profundo snoring) made my visit a more meaningful and memorable experience.
4. The Cost of Innovation
As I walked in my own front door a mere 26 hours after surgery, full of piss and vinegar and ready for action, I remembered my father. His first heart attack (at an age only slightly older than mine today) landed him in the hospital where his sternum was split open and a bypass performed. A dangerous operation followed by a lengthy hospital stay and a prolonged, home-bound period of recovery. That was then. The best there was at the time. Top-notch 20th century surgical technique and pharmaceutical therapy. It was very expensive and left him with a scar the size and shape of a Sonoran Gopher Snake.
Over 20 years later, all I have to remember my surgery by is a small catheter incision and a handful of booklets on heart-healthy nutrition.
Which I plan to read and act on.
Tennis anyone?
And yet, this is the same argument.
CMPI's Robert M. Goldberg, PhD Advocates for Reliable and Trustworthy Medical Information on the Internet from Zemoga on Vimeo.
AP’s Matt Perrone did a great job reporting the real risk-benefit bottom line but the Huffington Post managed to turn his account inside out with this headline:
Blogs were not much better for the most part:
Actually WebMD the FDA used the term “a possible association”
FDA Reports on Association of Breast Implants and a Rare Form of Lymphoma
Didn’t take long for mainstream outlets to go back to their unhealthy habits…
The Senator from SNL, Al Franken, has introduced legislation that would allow the federal government to negotiate lower drug prices for Medicare beneficiaries.
In other words, legislation that would abolish the Non-Interference Clause.
Franken says that his Prescription Drug and Health Improvement Act would cut prescription drug costs for seniors in Minnesota and across the country.
“When I travel around Minnesota, I always hear from seniors that they’re still paying far too much for prescription drugs,” Franken said.
That’s Franken nonsense.
Some things to consider:
"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
Stanford Business School's Alain Enthoven and Kyna Fong
"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause. Consider:
* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition.
* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
We shouldn’t interfere with success.
By revoking the Non-Interference clause, Uncle Sam will be able to "negotiate" prices for Part D drugs. That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head. There's also the potential for Uncle to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.
“Direct negotiations” means price controls. And price controls = choice controls.
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.
