Latest Drugwonks' Blog
Comparative Effectiveness Research and Alternative Medicine: Bring it On
"..Isn’t it at least possible that CER will focus on determining whether other commonly used therapies meet even that baseline standard?So rather than thinking of CER as a threat to big pharmaceutical brands, maybe there is an alternative vision for how it might work. Literally: as a tool to test the value of so-called “alternative” medicine."
Wow. As if that is the primary purpose of the $600 million a year the Agency for Healthcare Research and Quality will be receiving.
The In Vivo folks note: "Sebelius diplomatically avoided taking a stand on the value of alternative medicine, and stressed that private plans—not the feds—will decide what to cover."
I have a suggestion for In Vivo: Less sucking up to Sebelius and more reporting. Here is what the legislation actually has the feds deciding and using CER in making these decisions on behalf of consumers, doctors and private plans:
1. Development of a national health quality strategic plan that will be used for improving Federal payment policy with an emphasis on " quality and efficiency" (as in payments to health exchanges)
2. Establishment of annual benchmarks for each relevant agency to achieve national priorities. (see number 1)
3. Establishment of a " process for regular reporting by the agencies to the Secretary on the implementation of the strategic plan.
4. Strategies to align public and private payers with regard to quality and patient safety efforts.
5. Incorporating quality improvement and measurement (using CER) in the strategic plan for health information technology required by the American Recovery and Reinvestment Act
Just to make it clear (and maybe the In Vivo folks might want to break away from their fawning to check this out), the legislation requires: ‘quality
measure’ means a standard for measuring the performance and improvement of population health or of health plans, providers of services, and other clinicians in the delivery of health care services.
Then too, the legislation requires" A group health plan and a health insurance issuer offering group or individual health insurance coverage shall, at a minimum provide coverage for and shall not impose any cost sharing requirements for— ‘‘(1) evidence-based items or services that have in effect a rating of ‘A’ or ‘B’ in the current recommendations of the United States Preventive Services Task Force; ‘‘(2) immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved; and ‘‘(3) with respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration. "
How is this evidence developed? Through the application of comparative effectiveness research within the context of development of the quality strategic plan.
But of course " private plans—not the feds—will decide what to cover."
Which is why CER is required to be used to determine the the effect of new technologies on " national expenditures associated with a health care treatment, strategy, or health conditions....priorities in the National Strategy for quality care established under section 399H of the Public Health Service Act that are consistent with this section. "
But of course " private plans—not the feds—will decide what to cover."
In Vivo makes fun of those who worry about CER being used for rationing when it is obvious to them that all the CER dough will be allocated comparing flu shots to massages from chiropractors or aromatherapy. Of course it will. So we should ignore the fact that the legislation gives AHRQ significant authority in setting CER and quality agenda, control over dissemination of CER findings and preference in conducting and controlling CER research, especially as it pertains to coverage decisions for health plans, Medicaid and the Independent Medicare Advisory Board. And we should ignorestatutory language stating:
The Secretary may only use evidence and findings from research conducted under section 1181 to make a determination regarding coverage under title XVIII if such use is through an iterative and transparent process which includes public comment and considers the effect on subpopulations.
Paragraph (1) shall not be construed as preventing the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under title XVIII based upon a comparison of the difference in the effectiveness of alternative treatments in extending an individual’s life due to the individual’s age, disability, or terminal illness.
‘‘(d)(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive programs under title XVIII in a manner that precludes, or with the intent to discourage, an individual from choosing a health care treatment based on how the individual values the tradeoff between extending the length of their life and the risk of disability.
‘‘(2)(A) Paragraph (1) shall not be construed to— ‘‘(i) limit the application of differential copayments under title XVIII based on factors such as cost or type of service; or ‘‘(ii) prevent the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under such title based upon a comparison of the difference in the effectiveness of alternative health care treatments in extending an individual’s life due to that individual’s age, disability, or terminal illness.
Which if you flip it around means you can use CER to steer people to what you think is best using copays and limit coverage of new technologies if you think treatment A raises fewer questions about "safety" (and risk of death) than treatment B which is newer.
And in the final analysis, has anyone asked what the additional cost and time will mean to patients in terms of life expectancy, morbidity, cost of care?
The soundbite about AHRQ and CER is that it’s “non-political.” That remains to be seen. Previous examples of Uncle Sam as CRO (CATIE, ALLHAT) speak otherwise.
Consider this – NICE (the National Institute for Health and Clinical Excellence) is suspending publication of all decisions until after the U.K. general elections on May 6th. According to the Pink Sheet, “The decision reflects just how controversial the organization is in the U.K., where it has become a lightening rod for political debate.”
Something to think about.
According to a study in the May issue of Pediatrics, many Spanish-speaking people in the United States receive prescription instructions from the pharmacy so poorly translated that the medications are potentially hazardous to their health. (The errors occur largely because of deficiencies in computer programs that most pharmacies rely on to translate medication information from English to Spanish.)
This is an important issue that should be immediately addressed by the FDA as part of the agency’s Safe Use initiative.
This is a real health disparity that can and must be fixed inmediatamente.
People wanted to know how much control the government will or would have over medical decisions. And many people with cancer wrote in, wanting to know how the health plan might affect them and their ability to get insurance.
I said that the key issue going forward is to preserve individual choice and the ability to get medical treatment based on need, not cost.
That said, the first steps being taken to implement health care legislation are as follows:
1. Allocate $10 billion to the IRS and 17000 more IRS agents to review value of health care, whether you have it and to determine if your source of healthcare exempts you from paying a fine.
2. Allocate $250 million and add FBI agents to increase the number of Strike Teams swooping into the offices of physicians who seem to be overbilling based on an audit of claims data and not based on material evidence.
3. Give the Agency for Healthcare Research and Quality an additional $600 million a year to develop guidelines for determining what technologies, services and treatments should be covered in a "quality" health plan and for how doctors should practice medicine based on comparative effectiveness benchmarks that ignore individual differences.
4. Medicare cuts to hospice and home health care services.
People at the lower end of the income scale with cancer and serious disabilities will be forced in Medicaid. By 2014 the current rush of primary care doctors retiring and opting out of Medicaid will create "hollow health care" access. For speciality care and cancer treatment, Medicaid will have the right to restrict access to care and drugs based on comparative effectiveness. If a medicine is not on the Medicaid formulary you are out of luck.
I also predicted that at some point in time a health plan will go under, prompting the administration to take it over like it did GM and the banks. A very cheap way of creating a public option. Expect a lot of bailing out of the "too big to fail" health plan. ERs will be the place of last resort for millions and millions of other people will pay the fine, get coverage when they are sick, drop it when they are well again. This churning takes places in Medicaid all the time and it will spread to health care insurance in general because the incentive to game the system is built into the bill.
Finally, I suggested that just as people pay taxes and send their kids to public schools, people who want decent health care will pay up and buy into private health associations or go off-shore, paying out of pocket when they need or with the help of new gap insurance products.
It may all that we can do is create escape routes and underground railroads to let people secure the care they want and when they need it.
In America that is called market opportunity.
We often talk about the four rights – the right medicine for the right patient at the right time in the right dose. But that fourth “right” – dosing – often gets forgotten.
Today’s news, from the May edition of the American Journal of Preventive Medicine, finds that U.S. hospitalizations for poisoning by prescription opioids, sedatives and tranquilizers have jumped 65 percent from 1999 to 2006. That number is almost twice the increase in hospitalizations for poisonings by all other drugs and medicinal substances. “People are seeing headlines...and thinking 'it's sad and tragic but maybe it's just Hollywood,’ said lead author Jeffrey H. Coben, M.D., a professor and director of the Injury Control Research Center at the West Virginia University School of Medicine. “It's widespread throughout the U.S. and involves serious hospitalizations and is escalating at a rapid pace."
For those who don’t think that proper dosing isn’t an issue – think again.
It’s a killer.
Lilly CEO John Lechleiter: "I believe China will make a significant contribution to medical innovation in this century.”
Sales too (the Chinese market for pharmaceuticals is currently ranked the 7th largest in the world - and could jump to number three as soon as next year) – but that’s not the point. Lechleiter is thinking outside the box and it’s not the marketing and sales box.
According to the Pink Sheet, “Lilly has also begun linking an expanding array of Chinese scientists into its globe-spanning virtual research network. Eli Lilly's Robert Armstrong, one of the earliest advocates of replacing the R&D silos of traditional pharmaceutical companies with research networks that stretch from West to East, said in an earlier interview that Lilly is racing to construct a "dynamic matrix of partnerships across the globe aimed at R&D."
Lechleiter: "China is uniquely situated to play a key role in global pharmaceutical research and development … A growing number of Chinese scientists educated in other countries are returning home, adding to the tremendous human capital of this country and setting the stage for further innovation-driven growth. The 'brain drain' has become the 'brain gain' here in China.”
And, “As China seeks to expand its R&D base, what can this nation do to build its great potential to participate in the global innovation economy of the future?"
His primary suggestion involves IP rights – and rightfully so.
Leichleiter: "Above all there must be strong protection of intellectual property. China has made significant progress in intellectual property protection, developing a patent regime aligned with international systems. This is an essential first step to help foster innovation, but it is indeed just the first step.”
And without question there’s work to be done. In December 2009 China passed a new patent law that will allow domestic Chinese pharmaceutical manufacturers to manufacture knock-offs of on-patent medicines – and export them to third countries. According to Yin Xintian, director the regulations department of China’s State Intellectual Property Office, the new law will “ensure patients can get the drugs they need when they need them.”
Intellectual property rights are the fertile soil that facilitates the tree of pharmaceutical innovation to grow in the first place. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. That's a Silent Spring we cannot afford.
Leichleiter then issued a more general call for “conditions.”
"Creating and maintaining the conditions for innovation to flourish is challenging and complicated work - work that is never finished.”
Indeed.
Might this call for more “flourishing” conditions also include a regulatory “third way” to counterbalance both the FDA and EMEA? (Oops, I meant EMA).
Stay tuned.
According to a report in the Sunday Telegraph, David Cameron, the leader of the British Conservative Party, wants all patients with cancer to have broader access to all approved medicines – whether or not their use is backed by the National Institute for Health and Clinical Excellence (NICE), the NHS' rationing body.
Last month, research found that up to 20,000 lives may have been shortened by decisions taken by the NICE in the past year.
The Telegraph writes that, “Handing decisions back to patients and their doctors is a significant dismantling of the current system … In making yesterday's pledge Cameron chose local decision-making – and its inherent risks – over state control.”
Oscar Wilde quipped, “Experience is the name everyone gives to their mistakes.”
If that’s the case, then we should learn from the experience of our trans-Atlantic cousins.
The complete Telegraph article can be found here.
According to a report in the Helena Independent Record:
Gov. Brian Schweitzer, who last month asked the federal government to approve a “waiver” so Montana could import prescription drugs at lower cost for state-funded health plans, has not submitted any of the usual documentation that accompanies a waiver request, his administration acknowledges. Instead, the governor wrote only a letter to U.S. Health and Human Services Secretary Kathleen Sebelius, asking that her agency grant Montana a “Medicaid waiver” allowing importation of lower-cost drugs from Canada.
“We have to work through the secretary’s office,” says Anna Whiting Sorrell, director of the state Department of Public Health and Human Services. “There is not another state that has requested this. We think the governor is forging a new path.”
News must travel slowly in Montana.
There have been numerous requests for such waivers. And they’ve all been denied – for good reason.
Let’s look at the record.
Minnesota
During pre-announced visits by Minnesota State officials, Canadian Internet pharmacies were observed engaging in dangerous practices. For example:
- One pharmacy had its pharmacists check 100 new prescriptions or 300 refill prescriptions per hour, a volume so high that here is no way to assure safety.
- One pharmacy failed to label its products and several others failed to send any patient drug information to patients receiving prescription drugs.
- Drugs requiring refrigeration were being shipped un-refrigerated with no evidence that the products would remain stable.
- One pharmacy had no policy in place for drug recalls. Representatives of the pharmacy allegedly said that the patient could contact the pharmacy about a recall “if they wished."
- One of the Canadian internet pharmacy presidents said, “We won’t have any problems getting drugs. We have creative ways to get them.”
- The FDA launched an investigation confiscating thousands of drug shipments headed for the U.S. Some of them were headed for Minnesotans who ordered them over the state’s Web site. When opened, nearly half claimed to be of Canadian origin, but “85 percent of them were from 27 other countries including Iran, Ecuador and China. And 30 of them were counterfeit. One Minnesota resident discovered that one of his “Canadian” drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific. "I never heard of the place,” he said.
According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state -- population: 5,167,101.
Wisconsin
Modeled on the Minnesota program, the Wisconsin site hawks its promise and hides its dangers. All of the legalese buries the fact that the state doesn’t except any responsibility for the safety or effectiveness of any medicines bought on the State’s website. For example, the State won’t even guarantee that the drugs ordered are what the customer will receive. Not only that, but the State also says that they will not accept any legal responsibility or liability should any of the drugs cause a problem. The Governor is hiding the fact that his website puts any user into a dangerous buyer beware situation. Here’s the exact verbiage from the Wisconsin site:
“In no event shall the State Portal or its employees be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this system, even if advised of the possibility of such damage. This disclaimer of liability applies to any damages or injury, including but not limited to those caused by any failure of performance, error, omission, interruption, deletion, defect, delay in operation or transmission, computer virus, communication line failure, theft or destruction or unauthorized access to, alteration of, or use of record, whether for breach of contract, tortious behavior, negligence or under any other cause of action.”
Illinois
Remember Wrong-Way Rod Blagojevich’s swagger over his “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.
The City Experience
Remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006.
And speaking of Boston tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
And then, of course, there are those pesky safety issues.
Attention Governor Schweitzer -- The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
Last month Governor Schweitzer said that Montana could buy some of the drugs directly from wholesalers in Canada or place the orders and have them delivered to pharmacies around the state, for purchase by people covered by publicly funded health plans.
Someone should refer the Governor to Bartlett's Familiar Quotations:
“Those who cannot learn from history are doomed to repeat it”
And if that familiar quote from Santayana doesn’t get the point across, here’s a related one – “Remember the Alamo.”
The Montana state slogan is “the last best place.” Maybe so.
But not for drug importation.
I don't want to think in terms of repeal. Rather, I would prefer to use a medical or scientific analogy in describing how to respond to the effects of the legislation.The bill itself is a virus and we the people are the host if you will. Or consider it an experiment with every American forced into participation. Either way, we will be subject to new "solutions" that will have unknown consequences and side effects. As with any social experiment or massive program of social engineering, we will experience the end product in ways much different than promised. (If anyone has used on-line dating services, you know what I am talking about.)
Strategically, demanding outright repeal or defunding of health care reform sounds great to a small group. To build support for fundamental changes in what is now law will require exactly what the supporters of the current bill engaged in, nothing less and probably more:
1. Consistent and persistent evaluation of the performance of health care delivery systems. These standards should be easily grasped by most people and communicated easliy in visual form too. Are doctors leaving the system? Are people paying more or less for insurance? Are people any healthier?
2. Warning signs. The other side is hell bent on using health care reform to reduce our long term debt. Debt will rise because of spending unrelated to health care reform.To turn health care reform and by extension, every doctor and hospital, into any agent of deficit reduction first and foremost is a rationale for rationing care. And it is an immoral one at that.
3. An increasing reliance on the use of comparative effectiveness research to shape policy and health care coverage decisions. Increasiningly, to justify the need to avoid financial Armageddon, policymakers will rely upon CER to help make hard choices to slow health care spending in order to avoid “financial catastrophe.” If that sounds a lot like the narrative of the climate change crowd who used self-serving and secretive studies to support policies that also would lead to a decline in economic growth in order to save the planet, you are right. The “science” of CER demonstrating that a half to a third of health care spending is wasteful has much in common with the that of the hockey stick project about the atmosphere evaporating. It is not empirical or biological, it is speculative and has never been evaluated for it’s real impact on public health or human well-being. Should we take prescriptions that are not tested or are not based on an accurate representation of human or biological mechanisms? Yet CER is precisely that and it may be used to determine what preventive services are covered and what new benefits will qualify for reimbursement. It is possible to opt out of government run care because of conscientious objection to CER? I hope so..
4. Impact on innovation. Largely unnoticed, drug companies are filling up pipelines with new products.More and more of them are based on novel targets and rely on biomarkers linked to specific pathways and small populations. The number of molecular diagnostics to help predict, diagnose and monitor the progression of diseases or response to medicines are growing as is the business capacity to provide doctors and hospitals the ability to use this information. The progress will be incremental but it will come. The question is will future policies add to the cost and pace of progress or not? CER is only one such challenge. And alone it’s proponents will be left looking foolish and backwards. However changes to the FDA regulatory process can easily increase the time and cost of bringing new products to market and reduce the effective patent life of niche medicines. Demands to have a new center for drug safety review all NDAs before they go to market and for CER studies as a condition for approval would impose huge costs on innovation and the pubic health. Similarly, CER requirements can add more delay and uncertainty to the R&D process.
These are substantive concerns about the new health care bill that can be addressed through the writing of regulation and new legislation. We intend to track these issues as we have in the past. I don’t care if someone wants to call this approach repeal or reform or a do-over. I would like to think of restoring and improving the health of the system and all Americans.
From the Pink Sheet:
Pfizer is the fifth pharma company to post its payments to healthcare professionals but the first to include payments to principal investigators and institutions for conducting clinical trials.
The company posted the information on March 31, announcing that it paid a total of $35 million to 4,500 health care professionals for speaking, consulting and research services. The figure also includes meals and travel reimbursement. Of this sum, approximately $15.3 million went to research organizations for new clinical trials initiated after July 1, 2009, and for ongoing or new research between July 1 and December 31, 2009.
Pfizer said the clinical trial payments cover participant recruitment, coordinating and conducting the clinical trails and completing compliance activities to ensure regulatory requirements are met.
Pfizer was required to post all payments or transfers of value to physicians, including those relating to research, under a corporate integrity agreement with HHS' Office of Inspector General. The CIA accompanied Pfizer's $2.3 billion settlement with the Department of Justice to resolve allegations of off-label marketing of four drugs and kickbacks to healthcare providers involving nine other drugs.
The company's payment report also specifies non-cash payments, such as for meals or educations items worth $25 or more and totaling $500 or more during the six-month period. Pfizer is the first company to report these non-cash expenditures.
Lilly was the first to post payments to healthcare providers for consulting and speaking engagements, followed by Merck, GlaxoSmithKline and Cephalon. Cephalon was the first to do so under a CIA, which required it to report figures for a full year. The other three posted data for a single quarter.
Lilly's Top Speakers Earn $150,000 In Six Months
Cephalon has been the only company to clearly designate its highest-paid doctors, breaking out payments in $10,000 increments as required under its CIA. Pfizer's CIA gave it the option of listing the payments in $10,000 increments or in the actual amount paid and the company chose to report individual sums for 4,856 entities.
A Pfizer spokesperson said nine individuals received $50,000 to $150,000 and the remainder received less than $50,000. The company set a cap of $50,000 per year for individual speakers. But those with particular expertise can be cleared to receive a maximum of $150,000.
By comparison, Cephalon paid three doctors more than $140,000 in speaking fees during the year. And in a one quarter period GlaxoSmithKline's top speaker earned $99,375, Lilly's highest paid physician received $70,050 and Merck's top earner received $22,600.
Companies are now required to post payments to healthcare professionals under a provision included in the health care reform legislation signed into law last week. The law requires reporting of payments for consulting and speaking engagements, the value of certain meals and non-cash items like educational materials.
Pfizer said it will post its next report on March 31, 2011, which will include a full year of data for 2010 and include the value of all financial transactions, regardless of value. The company will post payment reports quarterly beginning in June 2011.
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.
