Latest Drugwonks' Blog
Counterfeit medicines are growing at such an alarming rate that it finally made it onto the recent Camp David G8 agenda. Counterfeit Avastin has found its way into America’s legitimate supply chain. It’s not just a theoretical problem any more. Now’s the time to close a major loophole that allows the purveyors of false profits to prey on an unsuspecting American public.
Now’s the time for a national standard for pharmaceutical track-and-trace that would enable manufacturers, wholesalers and distributors to provide documentation or a “pedigree” on the chain of custody of drug products, including identification of each prior sale, purchase or trade of a drug, along with the associated dates and parties involved
Earlier this month, 11 people were charged with the March 2010 record-breaking $75 million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010. Fortunately, all of the stolen drugs from the Lilly warehouse were recovered before they could be re-introduced into the legitimate supply chain. But we won’t always be so lucky.
Criminals are going to continue to attack our drug supply because they are always going to be attracted by the high value of drugs in the U.S. market. You can’t prevent criminals from making attempts, but you can make it whole lot more difficult.
Now, while the iron is hot, is the perfect time to strike a blow for drug safety. There’s a general placeholder in the Senate version of PDUFA bill that requires more specifics. Now’s the time for the FDA to roll up its sleeves and work with Congress to come up with a national standard instead of leaving it up to each state to come up with it’s own standard (as in California). In many respects, the only thing worse than no standard is to have 50 different standards that would create 50 different ways for counterfeiters to game the system.
This isn’t a new problem. The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President in 1988. PDMA was enacted to (1) ensure that drug products purchased by consumers are safe and effective, and (2) avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs. Both Congress and the FDA recognized that such legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs.
In 2004 (during my service as an FDA Associate Commissioner), I served on the agency’s first Counterfeit Drug Taskforce. Our report outlined a framework for public and private sector actions that could further protect Americans from counterfeit drugs, including implementation of new track and trace technologies to meet and surpass goals of the Prescription Drug Marketing Act (PDMA). Our framework called for a multi-layer approach to address the problem and included the following measures:
- Secure the product and packaging
- Secure the movement of drugs through the supply chain
- Secure business transactions
- Ensure appropriate regulatory oversight and enforcement
- Increase penalties
- Heighten vigilance and awareness
- International cooperation
But the devil is in the details and there’s always the danger of allowing the perfect to get in the way of the (public) good. Implementing PDMA has been a nightmare for 1000 reasons – not the least of which is a single, FDA-mandated track-and-trace technology. But time marches on. Technological advances since 1988 provide a plethora of possibilities. It’s time for the FDA to work with all stakeholders and put a national standard in place.
And the FDA won’t be acting alone. In a May 22nd colloquy, Senators Enzi and Harkin support moving forward with a more permanent and robust solution. Senator Enzi: “The language in the Manager’s Amendment is a placeholder to show our intent to continue working on this critical, but complex, policy.” Senator Harkin: “The logical next step in this policy is to work to improve the safety of the drug distribution system that gets drugs from manufacturers to the pharmacists and other providers who dispense them to patients. The FDA currently lacks the authority to establish a uniform, comprehensive national system to secure the pharmaceutical distribution supply chain.”
The complete colloquy can be found here.
It’s time to give the FDA the authority it needs to put 21st century track and trace into commission on behalf of the public health.
Compulsory what?
Drug regulation in India-the time is ripe for change
The Lancet
To say that India's drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO)-whose remit includes new drug approval, licensing of manufacturing facilities, and regulation of drug trials-is not fit for purpose seems a gross understatement.
A damning 118-page report from the Indian Parliamentary Standing Committee on Health and Family Welfare documents its successive failings. It describes a vast, geographically disseminated organisation that is dangerously understaffed: nine officers at headquarters deal with 20 000 applications, more than 200 meetings, 700 parliamentary questions, and 150 court cases per year. There is also a dearth of medically qualified staff, poor support infrastructure, a seeming lack of coordination between departments, and a scarcity of decent computer systems.
It is therefore not surprising that, of 42 approved drugs randomly chosen for investigation by the Committee, some had not passed through the correct regulatory channels. But the fact that 11 had no phase 3 studies done, 13 "did not have permission for sale in any of the major developed countries", and there was "no scientific evidence to show that...33 drugs are really effective and safe in Indian patients" points to problems at the very foundations of CDSCO. Its mission of meeting the aspirations ... demands and requirements of the pharmaceutical industry", rather than the protection of patients, is a very shaky foundation indeed.
The Committee's report has several suggestions for improvement. However, rather than trying to overhaul an organisation that is failing so catastrophically, India should seize this opportunity to wipe the slate clean and form a new drug regulatory body.
A smoothly running, professional drug regulatory body is essential to ensure, first, that high-quality, adequately assessed drugs are available to India's population and, second, that India's drug industry is regulated well enough to contribute successfully to India's domestic and export sectors. It should go without saying that whatever action India takes, the philosophy of the drug regulatory body should be the protection of patients, wherever they are.
This week the CDC recommended that baby boomers be screened for Hepatitis C. The motivation behind this recommendation is the development of a new class of Hepatitis C treatments that are in pill form and not injected.
Simplicity of treatment makes screening more successful. Yet people who are identified with the disease may have to pay more out of pocket for more effective and convenient care than they do for less effective and time consuming infusions.
That's because most health plans, following Medicare Part D, pay 100 percent of the cost of injectble drugs while paying only 70-80 percent of new oral medications. Since these drugs are expensive -- though relative to dying, permanent disability or the cost of repeated hospitalizations, organ transplants -- they are bargain patients wind up forking over tens of thousands of dollars for treatments do less. Moreover, because you can take a pill at home the cost of infusion goes away.
Our system of health care reimbursement is out of whack with the value of new, simpler treatments. It covers what is cheapest and then only covers in part technologies that work and are less instrusive if the cheap approach fails. That, not over use of tests ot treatments, is the biggest source of waste in health care, a source that could be eliminated if we did things right the first time,
Similarly, all new cancer drugs are in pill form. They make staying alive and healthier, simpler to do. They generate value for consumers who can go back to work, eliminate costly procedures such as blood transfusions, stem cell replacements and help avoid the side effects of chemo, which are tantamount to being shoved into a microwave while seasick.
Maybe Medicare and health plans think they are saving money by forcing people to pay a penalty for better treatments that are more convenient. They are wrong. There is mounds of data demonstrating that every dollar spent on new cancer and HIV drugs offset $7 spent other services. And the combination of longer life, improved health and increased productivity is not even accounted. My colleague John Vernon and I have shown that social value of increased health and longevity runs into the trillions. Advances in cancer alone have allowed people to live longer with fewer disabilities. If I were in control of my premium dollars, that's where I would want my money to go.
Instead, people -- particularly those with life threatening illnesses that are not caused by poor health habits -- have to pay more for these advances than any other health care service. Does it make sense to subsidize massage therapy or birthing pools at a higher level than pills that prevent cancer .
We don't need lots of legislation to change the paradigm. All the employers investing millions in 'wellness programs' could tell insurance plans the game has to change. States can introduce legislation making parity a requirement. Some will say this will add to the cost of premiums. So what? Studies have shown people are willing to pay more to be protected from catastrophic costs or give up the frills that are covered but never used. I bet a health plan that covered pills to treat hepatitis C and cancer could keep premiums where they are if they stopped covering the extras like acupuncture, chiropractors, massage therapy, gym memberships.
Our way of paying for health insurance and covering benefits is still pre-industrial. As I had mentioned in a previous post, you have to bribe doctors to use health IT even as thousands of health professionals are paying for iPads and using them in practice. Simplicity empowers. Medications are a highly efficient way of treating disease. I don't mind paying a portion of the cost of these treatments out of pocket. But it makes neither clinical or economic sense to force consumers to pay a higher percentage of the cost relative to less transformational care.
If somone running for public office wants an issue to campaign on, the tax on access to innovation that these co-pays impose is a great one. In the meantime, companies have to do a better job of showing it's innovative products enhances value by increasing clinical utility for patients and reducing the complexity of care. No doubt certain interests will oppose paying for progress that could eliminate their jobs or income. But the last time I checked, the typewriter and bank teller lobbies didh't have much success. On a related matter, why are we using clincal trial methodologies from the 19th century? From recruitment to treatment to followup, we can use digital technologies, biomarkers, remote sensors to cut the time and cost of evaluating new products in more than half.
Digital and personalized health technologies will creatively destroy the existing approach to medicine. Only regulation and political inertia stand in the way.
Change can be accelerated by we the patients. As Eric Topol has written: "the change will come from the truly empowered, beyond informed, consumer who has access to all the relevant data and is now fully participatory. This transcends the era of internet access to health information that started in the late1990’s, since now each individual should be able to access all of their biologic, physiologic, and anatomical data that was largely unobtainable before. And the earlier in life the better, in order to foster the critically needed emphasis on prevention of diseases—which
has been essentially ignored until now."
It's time to stop sticking it to patients when there are more empowering and powerful pills out there.
PDUFA passes Senate 96-1. 1= Bernie Sanders, the Senator from Ben & Jerry's.
When money speaks – the truth is silent.
-- Russian Proverb
I’ve just returned from Moscow where I was proud to participate in the first ISPOR conference (co-sponsored by the Ministry of Health) on HTA ever held in the Rodina. And it was a very worthwhile experience.
The meeting featured a cast of international HTA all-stars. Some useful take-aways:
Luigi Migliorini (the WHO’s Special Representative to the Russian Federation) noted that the conference was taking place at the same time as the World Health Assembly – which he referred to as “the Duma of the WHO.” Whether he was making a somewhat forced local reference or trying to make some type of political statement is up for debate.
Hans Severens (Erasmus University) spoke about “the possibilities and the impossibilities of HTA.” His main point (which became a mantra of all of the day’s presentations) is that, when it comes to HTA, “all decision-making must be made in a local context.” He also firmly stated that economic concerns are only one of many petals on the HTA flower – another point reinforced throughout the course of the program. Countries “shouldn’t just adopt NICE findings” but should assemble all available information and put all data into a local context.
If all politics is local – so to must HTA designs and decisions.
Severens said that, “all HTA research is biased.” This reinforces the point made by NICE’s Sir Michael Rawlins that HTA “is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists. There is no known piece of work which tells you what the threshold should be. It is elusive."
Elusive indeed.
Jérôme Boehm (Health and Consumer Directorate, European Commission) discussed the EC’s work towards developing protocols to share HTA data through a common database – but that “HTA must be a national decision.” He also added that there should be “no interference between market authorization and HTA.”
Wim Goettsch (Deputy Secretary, Medicinal Products Reimbursement Committee, the Netherlands) also affirmed that HTA decisions should be taken at the local level and that it needs to be as much about relative effectiveness (what we in the US refer to as comparative clinical effectiveness). He also pointed to an EU-wide database of HTA studies (www.eunethta.eu) that is becoming the “go-to” source for existing reports and information.
EUNETHTA, describes itself as “focusing on scientific cooperation in HTA in Europe, thirty four government appointed organisations from the EU Member States, Accession Countries and EEA work together to help developing reliable, timely, transparent and transferable information to contribute to HTAs in European countries.”
(Is PCORI aware of this? If not, they should spend some of their hundreds of millions of dollars doing so – rather than reinventing the wheel.)
And speaking of PCORI, Steve Pearson (Institute for Clinical and Economic Review), reinforced (and seemed to be bemoan) the fact that it cannot use any of its time or resources to address cost issues.
The US needs to learn from the successes as well as the failures of the European HTA experience. HTA isn’t easy. It isn’t foolproof. The science is in its early days and it is imprecise and cost containment is only one of many factors (and, according to all the speakers, not the most important). There isn’t a one-size-fits-all methodology. As Mark Twain quipped, “For every complex problem there is usually one simple answer – and it is usually wrong.” That’s an adage we should keep in mind. Alas – there is no universal Michael Moore-like “SiCKO” solution.
HTA cannot make political decisions – or make them any easier. A lesson we must learn as we debate the future of IPAB here at home.
Mira Pavlovic (Deputy Director, HAS) also spoke to the growing importance of EUNETHTA as well as the issues of HTA relative to choosing the best endpoints and comparators. She also addressed one of the 800 pound HTA gorillas – pharmacovigilance. She ended her talk by asking the big question – “Can we think prospectively.”
She also said that , since l’affaire Mediator, new conflict of interest rules have forced her agency to use physicians who have “sheep grazing around their offices.” Baa humbug.
Laura Sampietro-Colom (Hospital Clinic Barcelona and immediate Past-President of Healthcare Technology Assessment International – HTAi) discussed the importance of international cooperation and data sharing and the organizations own HTA database. She mentioned that AHRQ is a member of HTAi. (Hopefully Carolyn Clancy has shared her password with Joe Selby over at PCORI.)
According to conference organizer Vitaly Omelyanovskiy (Director, Research Center for Clinical and Economic Evaluation and Pharmacoeconomics, Russian National Research Medical University), HTA is the “near abroad” meaning that, while still a foreign concept – it’s not too foreign. Russia’s initial goal, accordingly, is to begin studying international (meaning European) HTA information and experiences so that a more “Russian-style” program can de developed.
The US has much to learn from this thoughtful Russian model because, as Leslie Levin (Head, Medical Advisory Secretariat, Health Quality Ontario) so elegantly put it, “Nobody can do it alone.”
Not enough – but it’s a start.
On Saturday, May 19th, the G8 issued the 40-point Camp David Declaration. Point 9 of the declaration includes:
"To protect public health and consumer safety, we also commit to exchange information on rogue internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products."
Not enough – but it’s a start. Just having the issue of drug safety on the agenda is a victory (as is a reaffirmation of the importance of intellectual property).
It's worth noting that according to our national law, any internet pharmacy attempting to sell prescription medicines to US citizens without a state pharmacy license is an illegal internet pharmacy.
Someone should share the G8 statement with Senator McCain and the other ill-advised supporters of drug importation.
The entire Camp David Declaration can be found here.
"The challenge of ecologic data is that it is impossible to reliably separate out the relative effects of any changes in screening, diagnosis, or treatment practices (or fundamental changes in the underlying risk of developing or dying of the disease in the population due to a multiplicity of other causes) that may have been occurring simultaneously over a given time period. "
This is pure dissembling BS designed to justify rationing.
Here is a more measured -- and patient-centered -- approach by urologist William Catalona:
The past half decade has seen a striking reduction of prostate cancer mortality rates in the US and other countries. The decrease has been ascribed, at least in part, to early diagnosis combined with more effective treatment, although there is no proof of a causal relationship.
Nevertheless, to the extent that early detection and effective treatment do reduce prostate cancer mortality and morbidity rates, PSA screening is clearly beneficial to many patients.
Some argue that PSA screening is not beneficial for all men screened because not every prostate cancer patient benefits from early diagnosis and treatment. Some tumors might never be life threatening and rare ones are incurable by the time the PSA level becomes elevated.
However, all available evidence suggests that PSA screening largely detects cancers that have features of clinically important cancers that are destined to cause suffering and death if untreated while they are still curable.
Some also argue that PSA screening is not beneficial to men who are never affected with prostate cancer. PSA screening does provide a feeling of well being in men who have persistently normal results, and even though a normal value can be misleading, with serial screening, PSA eventually reveals the cancer.
Docs formulate a list of differential diagnoses. Based on the list of possible causes of a particular problem, docs order diagnostic tests and procedures.
When I started in medicine over 30 years ago, we called the process ”rule out,” meaning we ordered tests to narrow the list of possible diagnoses until we found the right one. The more complex the disorder, the more tests are ordered.
In reality, docs don’t own a crystal ball. If they did, they would know which tests were going to be positive (necessary) and which were going to be negative (unnecessary). Since docs don’t have the ability to see into the future accurately, diagnoses and test ordering boils down to an educated guess.
To make matters worse, diseases are dynamic, forever changing. An eighteen year old comes in with a severe tonsillitis. Her mono test is negative.
Obviously, the test was not necessary since the test is negative. Right? Wrong! Ten days later she is seen again by another doc. Her mother states, “I took her to Dr. X 10 days ago and he didn’t know what he was doing. He wasted my money on a negative mono and strep test. Can you help her?” After explaining that a negative mono test is meaningless (as Dr. X had previously warned her), the new doc orders a repeat test which is now strongly positive. Diseases are dynamic and our ability to diagnose them correctly often improves with time as the disease evolves and changes.
Read the full piece here.
If it ever needs a reminder of how to spend billions to accelerate it's uselessness, FB can take a look at the monumental waste of money devoted to health IT and it's various spawn -- electronic medical records, e-prescribing, clinical decsions tools, and so on. This is not the most politically of correct statements. Everyone LOVEs health IT and predicts that it can save billions in medical spending, improve patient care, accelerate drug development, make stir-fry...
Let's set aside that no one has taken a hard look at whether health IT has done any of this. All we have are small, uncontrolled, observational studies that wind up proving health IT is 'transformational.' Ironically, the same group of underachieving health policy 'experts' who push comparative effectiveness research, who claim that industry sponsored research is corrupt and that doctors who receive industry (i.e. evil drug companies) support are conflicted, have no problem with anecdote-based reports paid for by health IT firms or companies that get paid to promote health IT or using the findings to reinforce their faith in health IT. And they have no problem with doctors getting health IT money or loans. But I digress.
The big problem with all the health IT hoopla is the fact that it's being lavished on technology and tools that are useless in a mobile environment. And apps that merely ape enterprise-based systems such as health information exchanges don't count. Those are about to become as outdated as typewriters and TVs with antennas or PCs for that matter. In my opinion, they already are. A big share of the blame goes to the establishment of the government health IT gravy train. The morass of standards, accreditation criteria, meaningful criteria, silly interoperability standards (requiring everyone to share clinical data the same way everywhere) have guaranteed that anything launched in the past five years or in the future, will be (or is) obsolete. Two quick examples, government sponsored health IT never anticipated integrating genomic information and clinical data. It never anticipated that both types of information could be generated, shared and stored by consumers themseves on something called a cloud.
One health IT veteran told me in exasperation that if the government had tried to standardize the 'meaningful' use of the internet we would be stuck with Mozilla. There would be no other browsers (what a quaint term!). Imagine if every company had to buy and sell products using the same accredited criteria, methods and interface. There would be no Amazon, eBay, Netflix, you name it.
Hence, health IT has a very big Facebook problem. The good news is that most people (meaning consumers) find electronic medical records, most health apps and other mobile health devices as boring, confusing and pretty much useless. There are dozens of companies promising their health info tools will reduce medical errors, improve patient outcomes, etc. But few of them make medical care or staying healthy simpler. The fact that we have to pay doctors to use health IT should tell you about it's capacity to provide that benefit. Did we have to pay physicians to use antibiotics instead of iron lung machines to treat TB? No one is paying health professionals to use iPads. Bribing and forcing doctors to use e-prescribing tells you something about whether most systems are really making prescribing safer and easier. Morever, the vast majority of doctors block out drug interaction alerts in e-prescribing systems for one very good reason: they slow down prescribing and never take into account benefits and risks of a treatment for specific patients.
BJ Fogg, a leader in figuring out how to get people to do things (which is really 90 percent of health care) observed:
"There are two paths to increasing ability. You can train people, giving them more skills, more ability to do the target behavior. That’s the hard path. Don’t take this route unless you really must. Training people is hard work, and most people resist learning new things. That’s just how we are as humans: lazy.
The better path is to make the target behavior easier to do. I call this Simplicity. In my Behavior Model I sometimes replace Ability with Simplicity. I hope this isn’t confusing. Ability is the correct general term in the model, but in practice Simplicity is what persuasion designers should seek. By focusing on Simplicity of the target behavior you increase Ability."
Facebook is seeking to find a way to make connecting, communicating and consuming, simpler. in the main BigHealth IT, which was conceived by technologists coming off a bad acid trip, has never given a rip about simplicity or ability. It's all been about the government money, not us.
Yes, dear reader, once more into the abyss.
Byron Dorgan may be gone, but the song remains the same.
On Monday, expect Senator McCain (with the misbegotten assistance of senators Vitter, Snow, Stabenow and other “usual suspects”) to try and tack on this importation amendment to PDUFA.
For shame.
While it is likely that cooler heads will prevail (since Leader Reid and HELP Chairman Harkin are likely to vote “nay”), vigilance is required to once again squash this bad idea that is so deleterious to the public health.
As the saying goes, nothing dies harder than a bad idea.
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.
