Latest Drugwonks' Blog
Peggy Hamburg:
“The user fee model has seen many major successes … including innovator prescription drugs, medical devices, animal drugs, and generic animal drugs, to name a few. Without a fair system of user fees, we simply cannot achieve for the public what we otherwise could.”
Bring your own bier.
Consider this new announcement from the good folks at Turkish Airlines:
TURKISH AIRLINES MEDICAL TOURISM SUPPORT PACKAGE
In order to increase share of Turkish Health Care establishments in the market and support national economy, Turkish Airlines has prepared a support package for Health Care Establishments who invest in Medical Tourism.
The airline’s package includes (among other incentives), “No rebooking penalty will be charged if the rebooking is required for medical complications.”
And that’s a good thing considering that, once in the land of Atatürk, the accidental tourist will discover a nation where access to the latest medicines is 4-5 years behind the US, Canada, Australia, Japan or any nation in the EU. From pain relievers to antibiotics, Turkey is the last country in Europe in terms of medical technology.
Medical tourist travelers on Turkish Airways should be reminded to bring their own prescription medicines.
I am very sad to report that our good friend and colleague Jack Calfee passed away last night, the victim of a heart attack.
Jack’s intelligence, honesty, wit and warmth were appreciated by those who knew him. His professional reputation speaks for itself.
Jack was always kind and helpful to me and was an indispensible guide along the shoals of healthcare policy.
And his eyes always had that wonderful twinkle.
Farewell Jack. Too soon.
Toronto Globe and Mail
It's time to stem the global flow of counterfeit medicines
Much is said and written about the global trade in illegal drugs such as cocaine and heroin: We know about the cartels and the drug wars, and we see the devastation wrought by drugs in the eyes of addicts and in crime statistics.
But rarely do we hear about an equally shady activity that almost rivals "recreational" drugs in size, scope and impact - the counterfeiting of medicines.
The U.S. Center for Medicine in the Public Interest estimates that the counterfeit drug market is worth about $75-billion a year.
About 15 per cent of all medicines sold worldwide are fakes. In developing nations of Africa, Asia and Latin America, it's about 30 per cent.
It's a deadly business, one that kills an estimated 700,000 people a year. That's because a lot of medicines for treating life-threatening diseases such as malaria and tuberculosis are fakes. So, too, are many antibiotics, painkillers, hormones, cancer meds and drugs for hypertension, high cholesterol and diabetes.
"Yet there is strangely little outrage at this globalized evil," according to the authors of a paper about counterfeit medicines published in the Journal of International Criminal Justice this week.
Consider that if you are caught smuggling a kilo of heroin across a border, you will likely go to jail for a long time. But if you're caught with a kilo of counterfeit medicines, you will likely be treated the same as someone smuggling a box of T-shirts - with a fine and a slap on the wrist.
The authors of the paper - Amir Attaran and Megan Kendall of the University of Ottawa and Roger Bate of the American Enterprise Institute in Washington - want that incongruous situation to change, and quickly.
The paper, Why and How to Make an International Crime of Medicine Counterfeiting, points out that counterfeiting of currency became an international crime in 1929: If you decide to print up some fake U.S. money, you are liable to prosecution in any country in the world, not just in the country where the activity took place.
"Humanity and the defence of public health requires doing likewise for counterfeit medicines," Dr. Attaran and his team wrote.
It's true that counterfeit medicine is a peripheral issue in Canada, though some of our infamous Internet pharmacies have been known to sell phony meds transited through other countries.
But Canada is - or should be - a good global citizen and look beyond its borders. It should be tackling the problem of counterfeit medicines with the same vigour as terrorism. And, according to Interpol, there is a link - al-Qaeda generates a significant portion of its revenues from counterfeit drugs.
For the most part, medicine counterfeiting is organized crime. The guy selling phony malaria pills at a roadside stand in rural Kenya is just the last cog in a criminal machine that turns ersatz ingredients into pills, prints plausible packaging, forges trademarks, distributes the products by tricking, bribing and evading customs and health officials and police, then launders the revenues from the illegal sales.
A criminal enterprise of this sort is not haphazard, and the response to it shouldn't be either.
But the World Health Organization, in a study of the impact of counterfeit drugs, said the trade is flourishing because laws are so weak.
The WHO highlighted myriad problems with the current legal regime, including insufficient regulation of drug manufacturing in many countries, poor enforcement of existing legislation, weak penal sanctions for violations and, above all, a lack of co-operation between countries.
"Knowingly making fake medicines that do not help people, or that harm and kill them, ought to be considered a more serious transnational crime than it is," Dr. Attaran said.
But there is a right way and a wrong way to fashion international law.
The Council of Europe is currently promoting the Medicrime Convention, a treaty to criminalize the manufacturing and trading of counterfeit drugs. The approach is inadequate because a) it applies only to Europe and b) it focuses too narrowly on protecting intellectual property.
This treaty seeks to criminalize a lot of what generic drug companies do - test the limits of patent law - but it does nothing to protect the poor Nigerian who is buying crushed chalk that he thinks is lifesaving malaria medication. It's a cynical attempt to shore up market share for brand-name companies. If that is what governments want to do, they should do so, but they shouldn't allow the victims of counterfeit drugs to become collateral damage.
A much better model for a treaty, Dr. Attaran said, is the Framework Convention on Tobacco Control, which tackles an international health problem in both developed and developing worlds by promoting measures and laws that cut across borders and attack the problem at its root.
In their paper, Dr. Attaran and his colleagues note that what they are proposing is nothing radical, and such a treaty is easily achievable, just as it was for counterfeit money. The sole impediment is a lack of political will.
"Meanwhile, counterfeit medicines go on killing. ... Absolutely no country is immune," Dr. Attaran said. "A more dismal commentary on the contemporary state of public health diplomacy is scarcely imaginable."
A new directive to protect patients from counterfeit drugs has been approved by the European Parliament.
New safeguards include extra safety features on drug packaging and new measures for internet pharmacies.
According to a recent report on the BBC, an estimated 1% of medicines sold to the public in Europe through legal channels are fake.
The 27 EU governments - the Council - will now study the directive and they can still make amendments before it becomes law. The final text will then be incorporated into national laws EU-wide within two years.
The legislation introduces a product authentication system and new safety features on packaging. The key to the system is a two-dimensional barcode added to prescription medicines that can be read by a new scanner.
More on this as it develops.
A new study from BIO and BioMedTracker reports that the success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.
The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.
Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.
Well – nobody said innovation was easy. But wait – it gets worse.
After saying that he wanted America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.
The President’s proposed 2012 budget blueprint seeks to hasten availability of biosimilars by cutting the market exclusivity of innovators from 12 years to seven.
Bad idea since a longer period of exclusivity funds an innovator company’s research and development efforts.
12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.
If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”
I know the answer! The answer lies within the heart of all mankind! The answer is twelve? I think I’m in the wrong building.
-- Charles Schulz
The Right Prescription
Obamacare's Sales Force
House Republicans plan to cut $360 million in Obamacare funding in this year's budget. That's a good start, enough to slow implementation of the health care law but not stop it. But not good enough to stop the administration from spending $100 million to run an ad campaign and hire a sales team to push Obamacare to thousands of doctors. That's right. Obamacare will use a sales force (with cars and expense accounts) to convince doctors that government health guidelines are the way to go.
The home of this marketing machine is Agency for Healthcare Research and Quality (AHRQ). Its budget of nearly $1 billion a year (starting in 2014 it will be more) is scheduled to be cut by only $25 million this fiscal year. Perhaps Republicans don't know that AHRQ is the operating system for Obamacare as well as its campaign manager.
AHRQ is mentioned in the Obamacare law 12 times. The agency and its consultants -- most of them true Obamacare believers -- are responsible for determining what preventive services we get, what health care "quality" is, what should be cut from Medicare and what new technologies should be paid for.
AHRQ was behind the decision to restrict breast exams to women over 50. It supplied the "evidence" for annual end of life counseling for the same seniors it decided shouldn't get screened for depression or hip fractures. Meanwhile, it's funding radical organizations pushing for sex change operations and the autism-vaccine link.
And it has big plans for the rest of that money. The Obama administration is not content to control what doctors do. It wants to control what they know as well. Carolyn Clancy, AHRQ's director, talks about "embedding" directives, guidelines, and reminders into the electronic health records of every American. AHRQ is spending millions to insert clinical decision support tools for a variety of purposes. One of the most prominently mentioned: end of life care counseling.
But AHRQ is not just content to "embed" Obamacontent into the lives of every American. It is also spending $50 million to "build a marketing campaign around comparative effectiveness research. (CER)." CER is promoted as information about what are the most medically and cost-effective treatments, drugs, and medical devices. But what works and what doesn't can change almost daily and varies by individual. Simple blood tests and iPad-equipped sensors will be able to monitor many illnesses before they spread as well as individualize treatment of a disease.
AHRQ is not only spending hundreds of millions of dollars on studies claiming there's insufficient evidence to either use or pay for such technologies.
AHRQ is spending millions to insure that its information is found more quickly and more often on the Internet. Over 70 percent of all Americans use the Web to seek out medical information. AHRQ plans to crowd out other sources of advice by making sure Obamacontent is embedded in as many websites as possible and using search engine tools to drive doctors and patients to government friendly or supported sites.
AHRQ is spending $34 million for an ad campaign to get doctors to adopt comparative effectiveness research. Here too, the campaign is heavy on Web-based tools with the goal of trying to get AHRQ and its consultants positioned as "experts" on Twitter, Facebook, YouTube, and search engines. It is buying up ad space in medical journals, which AHRQ is also flooding with its studies claiming most new technologies are more effective than old ones.
In case doctors don't get the message "embedded" in health records and the Internet, AHRQ is hiring hundreds of Obamacare sales reps to convince physicians that Obamacare medicine is the way to go. AHRQ's Obamareps will be paid $20 million to sell doctors AHRQ prescriptions. For instance, AHRQ reps will tell doctors that that all diabetes, hypertension, and prostate cancer treatments are more or less the same, often using data a decade old.
Medical science is way ahead of AHRQ. Doctors are able to tailor treatments to the race, gender, age, family history of a patient, as well as the pathways many forms of cancer takes. Today new imaging technologies and genetic tests can help predict cancer risk. But AHRQ's sales reps will tell doctors there's no evidence they save lives.
Obamacare 's overlords want to monopolize medical decisions and medical information while marginalizing everything else. That goal is central to setting up the health exchanges and limiting choice. AHRQ's multi-million marketing campaign is critical to both. Unless Congress cuts it budget to nearly nothing, it will be impossible to repeal the law and replace it with something better.
Yesterday the FDA held a “stakeholders” call to discuss the agency’s FY 2012 budget. Specific information will be shortly posted on the FDA website.
After a brief intro by Commissioner Hamburg, the heavy lifting was done by Patrick McGarey, Director, Office of the Budget.
Two items of particular note:
1- Within the 2012 budget is an allocation for $25 million for “advancing regulatory science.” (In fact, the Commissioner made specific note of the need for this in her opening remarks.) During the Q&A session, I asked what non-user fee monies were being allocated to the Reagan/Udall Center (RUC). The answer was, “none.”
That’s both disappointing and surprising since the (still not approved) fiscal 2011 FDA budget included $25 million for “scientific modernization under the Advancing Regulatory Science Initiative (ARSI). ARSI, as it was described at the time (February 2010), is a cross-center program whose ultimate objective is to provide FDA scientists with the skills to evaluate the safety, effectiveness and quality of products developed with new and emerging technologies, as well as give industry the standards by which such products will be judged.
Included in the 2011 budget for ARSI was $4.45 million in funding for the Critical Path Initiative. Why was that allocation zeroed-out? And all of this assuming the President gets full funding for his budgetary requests – which is not likely.
2- Mr. McGarey mentioned that the agency was working to develop a pathway for biosimilars that would be used “after the innovator’s patent had expired.” I asked if that meant that the agency had decided that the legislation that created a framework for such a pathway was based on patent life or data exclusivity. His answer, “I can answer with 100% certainty that that isn’t a budget question.” I hope that means he misspoke.
Lack of money is the root of all evil.
-- George Bernard Shaw
It was “give ‘em hell” Harry Truman who said, “Give me a one-handed economist. All my economists say on the other hand …”
Alas, when it comes to healthcare economics, it seems that “the other hand” is a focus (or rather a lack thereof) on patient care.
Consider this new press release:
DestinationRx Tools Yield $1 Billion in Savings on Prescription Drugs in 2010
Utilization of low-cost alternative reports leads to significant annual savings
LOS ANGELES--(BUSINESS WIRE)--DestinationRx, Inc., a leading provider of health plan and drug comparison tools, technology and data, today released data showing the substantial savings offered by the Company’s Drug Compare suite of online prescription drug comparison tools. An analysis of user activity in 2010 shows that the DestinationRx tools yielded an estimated $1 billion in savings for users, with a total of $13 billion in potential savings had all users acted on Drug Compare information.
According to a company spokesperson, “We hope to see even more success in 2011 as we expand and improve our tools to better serve Drug Compare users.”
Now that depends on who your "users" are, doesn't it?
On the one hand, by switching patients to less costly medicines that may not be as effective, money is indeed saved by payers – at least in the short term. But, on the other hand, what about the many metrics that demonstrate how switching patients for cost rather than therapeutic reasons results in poorer outcomes and increased costs in non-pharmaceutical interventions?
And isn’t the best patient outcome the desired … destination?
Ignorant men don’t know what good they hold in their hands until after they’ve flung it away.
-- Sophocles
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.
