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www.reuters.com/article/idUSTRE59P4UD20091026
Risks to personalized medicine seen in U.S. reform
By Julie Steenhuysen
CHICAGO (Reuters) - The federal government's push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual's genetic makeup, the chief of the National Institutes of Health said on Monday.
"There is a potential collision here," Dr. Francis Collins, director of the National Institutes of Health said at a forum sponsored by the American Association for the Advancement of Science.
Collins, a genetics pioneer tapped by President Barack Obama in July to head the NIH, said studies that lump together large groups of people to test the effectiveness of treatment A versus treatment B run the risk of overlooking clusters of people for whom a drug might have a dramatic effect.
"That's going to get lost in the wash by considering everybody equivalent, which we know they are not," said Collins, who helped lead the Human Genome Project that in 2003 produced a sequence of all the DNA in people.
"The antidote to that is pretty straightforward," said Collins, saying that studies need to include genetic information that allows researchers to find such responses.
Backers of comparative effectiveness research, who include insurers and large employers, see the government-funded studies as a way to learn which treatments work best. But Collins said the studies should be well crafted.
"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins told the meeting, which was broadcast on the Internet.
COST-CUTTING POTENTIAL
There is already evidence that personalized medicine can help reduce health costs, Collins said, pointing to Genomic Health's Oncotype DX, a genetic test that can predict the recurrence of breast cancer.
"This test allows those individuals at low risk for recurrence to know they are at low risk and make a decision about whether to forgo chemotherapy, with all of its adverse consequences, based on that information," Collins said.
He said the test costs $3,500, and most women who get tested and discover they are at low risk decide to forego chemotherapy, saving an average of $2,000 per patient in additional costs from chemotherapy treatment.
"In 2009, roughly 50,000 women are going through this process, predicting we will therefore save the healthcare system $100 million this year based on the availability of this kind of personalized medical test," Collins said.
Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told the meeting that many clinical trials are structured to determine if a drug is safe and effective in a large group of patients, but the drugs often leave out the why -- why certain patients benefit while others do not.
The FDA increasingly is approving drugs with companion diagnostic tests using biomarkers -- such as specific proteins or genes -- that improve the odds that a new, high-cost biotechnology drug will work.
She said studies that look at the genetic profile of patients and its role in how drugs work could strengthen a drug's application, lending more scientific certainty about why a new drug works.
"Perhaps then we could see more new drug applications in the pipeline that are more likely to succeed," she said.
(Editing by Eric Walsh)
1. It is not an entitlement.
2. It provides people with control over health care spending by funding health savings accounts
3. It both encourages and rewards healthy behavior and preventive care.
The program is modest in scope, limited now byt the fact that the federal government will allow Medicaid funds to be used only for less than ten percent of the chronically uninsured in the state. Part of the spending (the money put inton health savings accounts) comes from an increasein the tobacco tax.
But it is paired with the Daniels decision to add an HSA plan for all state employees and a program to encouage Hoosiers to improve their physicial condition through better diets, more exercise, etc.
Preliminary data shows that the state is spending less on healthcare and premiums are rising more slowly.
More important, before reforming or thinking about reforming an entire system, Daniels focused on:
1. the chronically uninsured who have the hardest time paying for coverage
2. changing the way health care isi paid for by focusing on rewarding health and giving consumers choice
In Washington just the oppostie is true. Healthcare reform is all encompassing and is an entitlement focusing on
1. the people who already have coverage
2. rewarding people for not getting insurance and postponing care
3. restricting choice
Also, Daniels has lowered the tax rate on biomedical innovation and created incentives for patent holders.
In Washington, taxes on innovators are going up and patent protection on innovative products will be cut in half.
Importantly, the measure includes $18 million for the Critical Path initiative, with at least $6 million of this set aside for partnership activities. Huzzah! Of the $6 million, $2 million will support research partnerships for the treatment or rapid diagnosis of tropical diseases, particularly tuberculosis and drug-resistant TB. A bit of mission creep – but no complaints.
The fiscal 2010 appropriations bill also increases direct non-user fee funding to the agency by 15%, bringing the agency's total budget with user fees to $3.25 billion.
The FDA will receive about $2.35 billion in direct funding, plus $893 million in user fees. This includes $235 million in fees to fund the new tobacco products program.
Interestingly, and relative to the issue of generic drugs and bioequivalence, Congress also requires that FDA report on adverse events and seizures associated with branded and generic epilepsy medicines. According to the conference report, "Specifically, the agency should examine the pharmacokinetic properties of 'A' rated anti-epileptic drugs from different manufacturers of the same therapeutic agent," the states. The agency must submit a report by September 30th, 2010 detailing what changes, if any, should be made to the current bioequivalence testing.
Critical Path funding. Partnership activities. Bioeqivalence. That’s progress.
Health Minister Chen Zhu said Web sites, advertisement companies, postal services, medical institutions and commercial banks involved in such illegal businesses are the main targets of the crackdown.
Shao Mingli, director of the State Food and Drug Administration, said the SFDA's official Web sites will name and shame those sites advertising fake drugs to alert the public. Most recently, the administration exposed six drug producers whose advertisements contain content of over-promised efficacy and guarantee in the name of consumers.
Shaming is good -- prison terms would be even better.
Consider this new op-ed from today's Detroit News:
Moderate Democrats, Republicans quietly work on health care bill
PETER PITTS
Republican Congressman Bill Cassidy recently broke some news that could turn the health care debate on its head. During a radio interview, he revealed that Blue Dog Democrats have been quietly reaching out to Republicans to draft an alternative health reform bill.
This isn't surprising. After all, neither Republicans nor centrist Democrats nor the majority of Americans approve of the clumsy hodgepodge of big-government policies that make up Sen. Max Baucus' health care bill.
An alliance between Republicans and moderate Democrats could give Americans the reform package they're looking for -- one aimed at lowering costs while promoting competition and choice.
Polls show that public support for health care reform is at a new low. According to a Rasmussen poll from Sept. 28, 56 percent of Americans oppose the leading Democratic reform proposal.
They're not alone. Blue Dog Democrats -- a group of 52 moderate Democratic members of Congress -- have long been uneasy about health care reforms that give too much power to the federal government. In fact they were among the leading opponents of the government-run "public option." Although that idea seems to be off the table, there's still plenty in the Baucus legislation for these fiscally conservative Democrats to criticize.
The nonprofit health care cooperatives that the Baucus bill creates, for instance, would create many of the same problems as the public option. It's true that these co-ops wouldn't officially be part of the government, but they would benefit from federal financial backing (the Baucus bill provides $6 billion for the establishment of these co-ops) and an implied federal guarantee. Consequently, they would pose a serious threat to Americans' ability to purchase private coverage.
Since co-ops would be able to draw from a healthy supply of federal funds, they could push private insurers out of the market by offering artificially low rates. This would soon result in a health care sector with few alternatives to the federally chartered co-ops.
At the same time, the Senate bill -- which carries an $856 billion price tag -- also fails to sufficiently address the issue of cost. A recent Gallup poll showed that the No. 1 concern Americans have about health care is cost and affordability.
And a bipartisan alternative to Baucus' legislation has the potential to be the kind of practical, cost-lowering bill that American's want and America's healthcare system needs.
What would such a bill look like? It's hard to say, but one smart way to go about crafting a bipartisan bill would be to model it off existing successful health care policies -- namely, Medicare Part D.
By creating a system where private insurers could fairly compete to offer Medicare beneficiaries the best drug coverage, Part D has reduced the number of seniors without drug coverage by 17 percent, while still managing to cost about 30 percent less than originally estimated.
The program also enjoys a 92 percent satisfaction rating. This is largely because Part D provides seniors with a real choice over the kind of drug coverage they receive (the program offers over 1,800 plans).
This basic model could be used as the basis for a new bipartisan healthcare bill. Under such a program, the federal government would expand coverage to chronically uninsured -- those 8 million to 15 million Americans who can't afford private coverage but earn too much for government aid -- by creating a system of privately administered health insurance options. Customers would choose the plan most appropriate for them, and the federal government would help subsidize their premiums, depending on their need.
Such a program would keep costs down by rewarding insurance companies for providing the best coverage at the lowest price. It would also give Americans the freedom to choose from a wide array of different insurance plans.
The time is right for a real bipartisan reform to take shape.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former Food and Drug Administration associate commissioner.
Dr. Cooper's research (which can found on his blog buzcooper.com/2009/07/29/what-if-the-problem-is-poverty/ ) clearly shows that proposals to have government penalize doctors who use more services than the lowest ten percentile (or reward those who use less services), reimburse according to evidence-based guidelines which are skewed to the less is best bias inherent in comparative effectiveness research, cut back payments to doctors in Medicaid and Medicare based on this mindset, limit the introduction of new technologies where government payment predominates, and envision increasing the number of Americans receiving care under this framework will mean cutting back drastically on access to medical treatment for poor people in urban areas.
Our panel of experts, moderated by CMPI senior fellow and former Congressman Mike Ferguson observed that central features of the current bills in Congress will guarantee that health care gets worse for minorities and the chronically ill, not better.
Michael Cannon, who runs health policy studies at Cato Institute (www.cato.org/people/michael-cannon ) noted that because Medicare and Medicaid are already the largest single source of payment, expanding the model will make it even harder to shift resources or change thinking in ways to focus on illness or disease prevention. The political culture will simply reorganize around the larger bureaucracy.
Joe Antos, the Wilson H. Taylor Scholar in Health Care and Retirement Policy at the American Enterprise Institute (www.aei.org/antos) pointed out that health care is a series of choices about care, cost, coverage and behavior. The issue is who should make these choices. The current proposals are hell-bent in centralizing such important decisions into the hands of a few government planners. Choices made by many to allocate resources thereby become rationing.
Jim Frogue , who is deputy director of Newt Gingrich's Center for Health Transformation (www.healthtransformation.net/cs/jim_frogue) emphasized that behavior is the key to health status for most chronic illnesses. Reforms that fail to focus on health improvement in a signficant way, or fail to free people to pursue prevention will make matters worse. While best practices are not one size fits all, Frogue noted that prevention approaches can be shared, adapted and refined for specific populations.
Finally, Gary Puckrein, President of the National Minority Quality Forum noted that advances in medical technology explain a considerable amount of the increase in life expectancy and survival over the last 50 years. The forum www.nmqf.org has identified by zip code where the greatest incidence of the most serious and costly chronic disease exists. It has tracked to the patient level who will cost the most in terms of Medicare expenditures and why. The failure to prevent diabetes explains much of the growing cost of Medicare and it can be traced to specific urban areas, areas that will see money cut because it is defined as "wasteful" when it could be transformed into more effective forms of care.
The battle of health care then is not "yes" or "no" but "how." Medical innovation is and should continue to be an American growth industry and a source of productivity. The current approach to reform undermines and discourages transformation, drives up cost and slows the development of the next generation of technologies.
More importantly, the mass of regulation assures that the health care equivalent of a Bill Gates or Eric Schmidt will not emerge to lead and transform a critical and competitive American industry.
Ad Age reports:
The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.
The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.
The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.
Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."
Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.
The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.
The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.
What about the other nine years?
That, it seems, is the purview of S.1776 and, according to the New York Times, “Congressional Democrats have no plans to offset the cost of S. 1776, which is why they are eager to keep it separate from the broader health care legislation and avoid breaking the president’s promise.”
That promise again, “I will not sign a plan that adds one dime to our deficits — either now or in the future. Period.”
Well, it seems that many in Congress are looking at the “period” and seeing an ellipse.
The Times continues, “Congressional Democrats insist that fixing the doctor payment formula should not count toward the cost of the big health care legislation, because it is a problem they inherited.”
Unlike the problem of the uninsured? Unlike the problem of preexisting conditions? Unlike the problem of the donut hole? Unlike the problem of (FILL IN THE BLANK)?
Sounds like a total ellipse of the sum.
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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.
