Latest Drugwonks' Blog
"He praised the pharmaceutical industry for making a hard commitment, but added, We might be able to get $100 billion out of them, or more. Mr. Obama offered no specific plans to increase the companies’ contributions to health care savings."
Folks -- 10% of our national healthcare spend cannot finance the other 90%.
Hullo?
Hence, this in Health Affairs...
Bethesda, MD -- Are drugs known as "second-generation antipsychotics" (SGAs) being overused and misused? What steps can be taken to make sure that medications are used correctly? Those questions are addressed in a trio of articles published today on the Health Affairs Web site.
Read article here
SGAs, also known as "atypical antipsychotics," have largely replaced older, less expensive first-generation (or typical) antipsychotics in the treatment of schizophrenia. SGAs are increasingly being used for a wide range of other clinical conditions as well.
The cost of SGAs is typically from ten to 100 times the cost of "first-generation" antipsychotics, and domestic U.S. sales of SGAs have reached $13 billion a year. However, based on recent research, some experts believe that the overall risk-benefit profiles of SGAs may be no better than those of some of the older and cheaper medications they have displaced, although important questions remain to be addressed through further research, and considerable variation exists in treatment response across individual antipsychotic drugs. While SGAs appear to cause fewer "extrapyramidal" side effects, including serious movement disorders, they bring increased risk of weight gain and blood-lipid abnormalities that may increase the risk of heart disease and diabetes.
Other researchers believe that SGAs can offer important new benefits for patients with schizophrenia and other serious mental conditions, but that the broadened use of these drugs for a more clinically diverse population of patients may have outstripped the evidence base for such use.
Examining The Use Of SGAs Among Youth and Elderly. In "Broadened Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy Challenges" Stephen Crystal and coauthors document the increased use of SGAs on the two ends of the age spectrum, the nation’s youth and the elderly in nursing homes. When the researchers examined youth in seven state Medicaid programs, they found that 4.2 percent of enrollees ages 6-17 filled at least one prescription for an antipsychotic medication in 2004, up from 2.7 percent in 2001. Virtually all of the antipsychotics used were SGAs.
Read article here
Clinical indications approved by the Food and Drug Administration for antipsychotics in young people are limited to schizophrenia, behavioral symptoms in autism, Tourette’s disorder, and mixed or manic bipolar episodes. But in 2004, one-third of the youth in the seven Medicaid programs studied were being treated for attention deficit hyperactivity disorder without diagnostic codes for more-serious diagnoses such as schizophrenia, autism or bipolar disorder, according to Crystal, director of the Center for Education and Research on Mental Health Therapeutics in the Center for Pharmacotherapy at Rutgers University, and colleagues. Overall, almost three-quarters of Medicaid youth receiving antipsychotics were being treated only for conditions for which no FDA clinical indication existed. The results were similar among privately insured youth.
Likewise, among elderly nursing home residents, most use was for residents without an FDA diagnostic indication, and use increased from 1999 to 2006 despite new safety concerns including FDA warnings of increased mortality associated with use among elderly with dementia. Among nursing home residents in 2006, 27.6 percent were receiving antipsychotics, up from 20.2 percent in 1999.
Increasing Information To Ease Resistance To Practice Changes. In "Developing A Policy For Second-Generation Antipsychotic Drugs," Robert Rosenheck and Michael Sernyak report that many SGAs were prescribed for questionable reasons at one university-affiliated Veterans Affairs health center caring for veterans with serious mental illness. "The most frequent reasons given for prescribing SGAs … were greater efficacy, followed by patient preference and sedation/sleep, none of which is well-supported by current research. In contrast, prevention of neurological side effects – the reason for using SGAs with the strongest research support – was the least frequently cited reason for starting a new SGA," say Rosenheck, codirector of the New England Mental Illness Research, Education, and Clinical Center at the VA Connecticut Health Care System, and Sernyak, chief of the Mental Health Service at the VA Connecticut Health Care System.
Read article here
Rosenheck and Sernyak suggest that the most appropriate policy would be "stepped therapy," in which patients would have to start on first-generation antipsychotics and would only be allowed to try the SGAs with the most risk of side effects if other drugs had failed to help them. However, this policy would be likely to meet resistance, the authors acknowledge. They suggest that "counter-detailing, with its emphasis on individualized education and direct feedback, may be crucial in garnering the understanding and needed support for successful implementation of meaningful practice change."
Notice, no measure of individual response or outcomes..
Whereas David Meltzer and co. note what happens when individual responses to individual drugs are counted...
The Need For More Comparative Effectiveness Research. In "Comparative Effectiveness Research for Antipsychotic Medications: How Much Is Enough?" David Meltzer and coauthors examine a high-profile study funded by the National Institutes of Health that has been used to argue for restricting coverage of SGAs. In 2006, a cost-effectiveness analysis based on this study – known as the Clinical Antipsychotic Trials of Intervention Effectiveness study, or CATIE – found that "treatment with perphenazine [a first-generation antipsychotic] was less costly than treatment with second-generation antipsychotics with no significant differences in measures of effectiveness."
Read more here
However, there are a number of concerns about CATIE’s design that create "great uncertainty about the extent to which CATIE findings should be used to make coverage policy," write Meltzer, Director of the Center for Health and the Social Sciences at the University of Chicago, and colleagues. The authors present a model that they say indicates that additional comparative effective research involving SGAs would be of immense value – exceeding $300 billion – to those who have schizophrenia today and to those who will develop it over the next 20 years. The model also suggests that it would be worthwhile to perform studies of the effectiveness of SGAs with much larger sample sizes than CATIE, on the order of 8,300 patients in each treatment group as opposed to the 400 patients per group in CATIE. The model indicates that studies of cost-effectiveness should be even larger and would offer the greatest value.
Larger? I don't think so. I think spending money developing/testing predictive and biomarker based tools in observational settings would be a lot cheaper.
What are people thinking?
After the embargo lifts, you can read the article by Crystal and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w770
After the embargo lifts, you can read the article by Rosenheck and Sernyak at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w782
After the embargo lifts, you can read the article by Meltzer and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w794
Three of the most common “urban myths” of American healthcare are that:
1. The lower life expectancy in the U.S. “proves” the total inadequacy of our system;
2. There are 47 million uninsured Americans — proving the inequity of our system; and
3. We spend “too much” on health care — proving the wastefulness of our system.
For the rest of the story, see this new op-ed, part of the Reuters’s “Great Debate” series on healthcare reform.
As the old saying goes, everything you read in the newspaper is true, except for those things you know about personally. Healthcare reform is too important (and too complicated) to permit reform by sound bite.
Then, when you read the article, you see that those doing the criticizing are ... insurance companies while those doing the praising are ... patients.
Why not a headline that reads, "Patients Praise Drug Makers for Co-Pay Subsidies."
I know -- man bites dog.
Steve Usdin reports in BioCentury:
“In bending political opinion about biosimilars, BIO benefited from the services of prominent Democrats, most notably former Democratic National Committee chair and former Vermont Gov. Howard Dean, and perennial Democratic presidential campaign manager Joe Trippi, as well as well-placed lobbying firms. Trippi and Dean are not registered as lobbyists. Their activity, which supplemented the efforts of BIO’s in-house and external lobbyists, may not have met the legal criteria for requiring registration, but it was aimed at influencing the views and votes of members of Congress.”
“Dean, who represents the progressive, or more liberal, wing of the Democratic Party, surprised many on the political left by writing a commentary on biosimilars that was published in the July 8 issue of The Hill, a newspaper that is widely read on Capitol Hill. Dean repeated BIO’s talking points on biosimilars, contending that a “commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years.” Dean, who attacked pharmaceutical company profits during his 2004 presidential campaign, wrote in the commentary that a “shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cure.” The Hill identified Dean as a physician, ‘former Vermont governor, Democratic National Committee chairman and presidential candidate,’ but did not mention any relationship with BIO.”
"In his e-mail to board members, Greenwood did not fail to include Dean in his praise. ‘Our team at BIO, the D.C. offices of our members, our consultants (now including former Vermont Governor and Democratic National Committee Chairman Howard Dean) did a magnificent job,’ he wrote. Dean told BioCentury last week that he provides ‘long-term and short-term strategic advice to BIO. I do not lobby.’ ”
In the same article Usdin also reports:
“Speaking at a briefing last week at the Center for Medicine in the Public Interest, Rep. Anna Eshoo (D-Calif.) said she plans to introduce a version of her Pathway for Biosimilars Act (H.R. 1548) as an amendment during Energy and Commerce Committee markup of its draft healthcare reform legislation.
The Eshoo amendment, which hasn’t been publicly released, “embodies the strengths of both H.R. 1548, as well as the recently passed Hatch/Enzi/Hagan Amendment at the HELP Senate Committee,” Greenwood noted in a July 16 letter of support for the Eshoo amendment.”
“The Eshoo amendment combines the 12-year exclusivity provisions passed by HELP last week “while also retaining the important provisions in H.R. 1548 aimed at avoiding patient and provider confusion over biosimilar products and ensuring patent disputes will be resolved prior to the expiry of data exclusivity.’ “
“Greenwood’s letter stated. H.R. 1548 requires that all biosimilars be assigned a unique international non-proprietary name (INN) rather than adopt the INN for the reference product as is the case for generic drugs. BIO has advocated for unique INNs, while biosimilars manufacturers oppose this as a barrier to interchangeability. Eshoo seems to have lined up enough support in the Energy and Commerce Committee to get the amendment passed — 23 of its 59 members are co-sponsors — if a vote is taken.”
CMPI (the public policy home of drugwonks.com) was proud to have sponsored that event (which also included comments by Representative Mike Rogers (R, MI), the Honorable Mike Ferguson, Former Vice-Chairman of the House Health Subcommittee (and a CMPI senior fellow), John F. Crowley, CEO, Amicus Therapeutics, Founder, CrowleyFamily5.com, and Dr. Geno Merli, Senior Vice President & Chief Medical Officer, Thomas Jefferson University, and Director, Jefferson Center for Vascular Diseases.
Video of this event will be available shortly on www.cmpi.org
The Internet is agnostic. It’s a library without a librarian. The Internet is agnostic to truth, accuracy, and spelling. So, when we talk about social media, it’s imperative to view it separate and apart from “the agnostic Internet.” Social media uses the Internet as its delivery mechanism and is anything but agnostic. The Internet is not social media – it is the playing field of social media.
If the Battle of Waterloo was won on the playing-fields of Eton, wither the battle of social media and healthcare? While everyone else is using social media as a healthcare communications blitzkrieg, or “lightening war,” regulated industry is digging in for a sitzkrieg, a “sitting war.”
This is not good news for pharma, physicians, or patients. Social media is driven in real time by facts (often wrong), statistics (regularly misunderstood), snake oil salesmen (wearing white coats), and just plain folks looking for information from a variety of sources – the most important being each other. Social media is the newest arrow in the quiver of social marketing, but it’s a discipline both misunderstood and frightening to those operating in the heavily regulated world of healthcare.
Pharma mustn’t feel safe behind a social media Maginot Line strategy.
Democrats are touting the fact that the AMA has signed on to their health care reform effort. But is the AMA really representing the views of its members, or are they playing a Washington game: currying favor with the Democrat majority, in the hopes that when negotiators decide who’ll pay for national health care, they’re not left holding the bill? Here’s one suggestion that the AMA leadership may be getting ahead of its rank and file:
Concerned that the American Medical Association has taken too tepid a position on Democratic healthcare reform plans, a coalition of state medical associations and specialty organizations is breaking from the country’s largest physicians’ group to mount its own push against the inclusion of a public insurance option in any overhaul bill.Seventeen state medical associations and three specialty physicians’ groups planned a conference call late Wednesday to discuss a draft letter that would go much further than the AMA’s more measured responses to the public option.
The AMA has made clear it is not opposed to a public plan, but would resist a Medicare-like program that mandates physician participation and pays less than their costs..
The draft letter, written by members of the Medical Association of Georgia, says flatly that the physicians’ groups unequivocally oppose a government-administered insurance plan, as well as use of government-funded effectiveness tests, or “comparative effectiveness research,” to dictate which medical procedures should be eligible for coverage…
A Republican aide familiar with the coalition’s concerns said the physicians’ groups especially worry that AMA’s position on public option language in the House’s developing legislation has been “too squishy…”
“Physicians have been offered a seat at the table so long as we sit still with our hands folded in our laps and keep our mouths shut,” wrote John Black president of the South Carolina association, and Gary Delaney, the group’s chairman. “The muzzle that the Feds placed on us must be removed and the decibel level of our voices must be raised so that we are unmistakably heard.”
In addition to Georgia and South Carolina, state medical associations from New Jersey, Florida, Arkansas, Virginia and 10 other states and the District of Columbia planned to discuss the letter and consider signing it.
The Triological Society and the American Academy of Facial Plastic and Reconstructive Surgery were also invited to participate in Wednesday’s discussion, said a spokeswoman for the Georgia group.
Seventeen state associations are considering separating themselves from the national AMA to make clear that they oppose a government-run plan. That doesn’t completely devalue the AMA’s position, but it certainly makes you wonder what could have caused such a sudden and dramatic reversal. Given the threats Democrats have been leveling against groups that refuse to cooperate with their agenda, it would be no surprise if the AMA’s leadership simply calculated that it would be more dangerous to fight than to give in.
We’ll know in the next few days how many state associations are willing to buck their leadership and sign on to this letter. I wonder how much attention that will receive.
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.
