Latest Drugwonks' Blog
U.S. Healthcare: Most Expensive and Worst Performing
In a new international ranking, the United Kingdom ranks first, while the U.S. performs poorly across almost all health metrics.
This study -- or rather a version of it conducted by the World Health Organization -- has been thoroughly shredded by Scott Atlas in his Commentary article: The Worst Study Ever?
As Atlas points out: "researchers divided aspects of health care into subjective categories and tailored the definitions to suit their political aims. They allowed fundamental flaws in methodology, large margins of error in data, and overt bias in data analysis, and then offered conclusions despite enormous gaps in the data they did have."
All to make the case for single payer health systems.
In this case, the Commonwealth Fund measures everything except the quality of care. It measures lots of process measures that are easily skewed by bias. So for instance, in measuring "efficiency" CW ranks countries based on percentage of GDP spent on health and percent of health care spent on administrative services. Of course the US is destined to be the worst.
Next, it ranks countries on access. Again the US is trashed. And the UK is number 1. Don't laugh. CW used "having access to basic medical care the same or next day." Apparently wait times for cancer care, hip replacements, by-pass surgeries, etc. don't count. Indeed, CW ignores the explosion in outpatient same day surgery and walk-in clinics in the US.
The US is also slammed for unfairness. CW claims -- surprise! -- that the UK does the best on providing the same great care to everyone rich and poor. Apparently, despite the exhaustive research CW did, the group failed to come across the Marmot report calling health inequality in the UK a ticking time bomb. Here's the link in case CW wants to update it's study:
Meanwhile, CW ignores the following (courtesy of Scott Atlas again!):
"American cancer patients, both men and women, have superior survival rates for all major cancers. Removing “lead-time bias,” where simply detecting cancer earlier might falsely demonstrate longer survival, death rates from prostate and breast cancer from the early 1980’s to 2005 declined much faster in the US than in the 15 other OECD nations studied (Australia, Austria, Canada, Finland, France, Germany, Greece, Italy, Japan, the Netherlands, Norway, Spain, Sweden, Switzerland, and UK)."
What about heart disease?
"A comparison of the US to ten Western European nations (Austria, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, and Switzerland) showed that 60.7 percent of Americans diagnosed with heart disease were actually receiving medication for it, while only 54.5 percent of Western Europeans were treated (a statistically significant difference)."
Also...
"Another comparison study showed that fewer Americans than UK residents die (per capita) from heart attack despite the far higher burden of risk factors in Americans for these fatal events. In fact, the heart disease mortality rate in England was 36 percent higher than that in the US. These superior outcomes from US medical care are particularly impressive, considering that American patients have far more risk factors (diabetes, obesity, chronic kidney disease) that worsen outcomes and death rates after heart attack and after heart surgery.
The US shows a far greater reduction in death rates from stroke, the third leading cause of death and the leading cause of disability in adults in the US and most Western European nations, than almost all Western European nations and the European Union overall."
So why did CW ignore outcomes like mortality and survival and focus on income inequality and how universal a health care system was.
You have to take into account CW's frame of reference. If someone told you time again that the VA health system is a model of excellence, would you take their study on health care performance seriously?
And boy does Commonwealth love the VA.
Here's CW president Stephen Shoenbaum gushing over the VA in an interview with Managed Care magazine:
MC What parts of the health care system are working?
SCHOENBAUM: There are some examples of excellence within the U.S. health system. If we pick any given area, such as quality or driving down costs, we find examples of excellence. Some large systems are doing very interesting things. Kaiser Permanente and the Veterans Administration are managed systems that are trying to improve performance and reduce costs by using a primary care-based system and using information technology creatively. Another example is Geisinger Health System in Pennsylvania.
And here's a CW study of the VA, which it claims is a high performing health system. I take that to mean it meets the standards CW set in the report dumping on US health care. The study celebrates how the Memphis and Lincoln, Nebraska VA systems shortened wait times, reduced emergecny room vistis and reduced blood sugar levels in some patients.
Hmm.. Memphis VA.. where have I heard that before..
VA Hospital Axed Veteran Programs While Approving $1 Million In Bonuses
The Memphis Veteran Administration (VA) Medical Center approved over $1 million in bonuses months before closing a therapeutic aquatic pool citing a lack of funds.
The Memphis VA Medical Center handed out $1,005,644 in bonuses for its approximately 2,000 employees in fiscal year 2010, according to data provided to The Daily Caller by Sandra Glover, the communications officer for Veteran Integrated Services Network (VISN) 9, which includes the Memphis VA Medical Center.."
And this:
Memphis Veterans Affairs Medical Center Flagged in Audit
The CW study is an exercise in confirmation bias, which is the " tendency to search for or interpret information in a way that confirms one's preconceptions, leading to statistical errors. Confirmation bias is a type of cognitive bias and represents an error of inductive inference toward confirmation of the hypothesis under study."
It was designed to reinforce the meme that goverment run health systems are better, fairer and cheaper. This blog was a modest effort to speak truth to bias.
Here's a story from The Pharma Times on how NICE is searching for multiple ways to say "no". That will of course lead to delays in access, during which time people will die. Now that's a way of reducing the "drain on healthcare resources."
NICE asks for more data on Sovaldi
WORLD NEWS | JUNE 17, 2014Tweet
SELINA MCKEE
NICE asks for more data on Sovaldi
Cost regulators for National Health Service treatments in England and Wales have raised an eyebrow or two by asking Gilead for more information on its hepatitis C wonder drug Sovaldi (sofosbuvir).
In draft guidelines the National Institute for Health and Care Excellence (NICE) said it is minded not to recommend Sovaldi, despite the drug being linked with cure rates of over 90% in just 12 weeks.
While the Institute conceded that available evidence shows Sovaldi is an effective treatment for chronic hepatitis C in certain patients, "evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer", it said, explaining its current stance.
"The Committee has therefore requested further information from the manufacturer before it can decide whether sofosbuvir is a cost-effective use of NHS resources".
Move unexpected
The move came as somewhat of a surprise given that, in April this year, NHS England approved funding for Sovaldi in England and Wales significantly at risk of dying or needing a liver transplant, while the Scottish Medicines Consortium cleared its restricted use on NHS Scotland.
The drug was approved for use in Europe in January this year, but has been in the spotlight globally for some time because of its widely-perceived high price tag as much as its stellar effectiveness. With a 12-week course costing just shy of £35,000 in the UK, there are concerns that the drug could prove to be a devastating drain on healthcare resources.
On the other hand, the price of not using Sovaldi is could run much much higher; one in three patients injected with HCV eventually developing liver cirrhosis and managing these patients is costly.
Charles Gore, chief executive of the Hepatitis C Trust, said the drug's high price "should not put off commissioners because price is not supposed to be the determinant – cost-effectiveness is".
"If NICE OK Sovaldi, it should be prescribed to anyone who wants it. We have the Pharmaceutical Price Regulation Scheme (PPRS) to cap the drugs budget," he noted.
The closing date for comments on the draft guidance is 4 July 2014.
New combo shows 100% response rates
Meanwhile, Gilead also unveiled Phase III data showing that the fixed-dose combination of the NS5A inhibitor ledipasvir and sofosbuvir achieved 100% sustained virology response in hepatitis C patients in Japan.
The cure rates observed "are impressive because they were achieved without the need for interferon or ribavirin, both of which involve more complex dosing requirements and may be associated with significant side effects,” said Norbert Bischofberger, Gilead’s Chief Scientific Officer.
The results suggest that the once-daily pill "has the potential to be an efficacious and well-tolerated regimen" for many patients in Japan, he added.
Recently Allison Bell, a blogger for LifeHealthPro.com, a newsletter focusing on how insurance companies can maximize revenue posted on CMPI's effort to focus on the value of new cancer treatments from the patient's perspective.. Here's her post and my reply.
On the Third Hand: Drugs Opinion
Thanks Allison,
You raise important questions that need to be answered.. unfortunately until now no one has wanted to check the math.
Here's some math: According to IMS the number of targeted has increased from 11 percent of all cancer drugs to 46 percent of all drugs over the past decade. The average price of drugs has doubled. Meanwhile, cancer drugs as a percent of healthcare spending has actually declined. The rate of hospitalization for cancer has fallen by 20 percent during the same time period. Cancer mortality rates have declined 20 percent. Productivity gains of people living cancer free are conservatively estimated at $68 billion a year, or 2.5 times more than what was spent on new treatments.
New drugs and diagnostics are responsible for 90 percent of these gains.
I would argue that the way to make a system sustainable is to increase productivity (which leads to more people paying premiums and taxe) and reduce the use of more labor intensive services like hospitals. Without new cancer drugs there would be 6 milion fewer people alive today. Without 'expensive' HIV drugs that are also being rationed by health plans, there would be 3-5 milion fewer people alive today. If you cut the work force and tax base by 20- 30 percent by denying access in ways AHIP wants, what happens to the financial support everyone seems to worry about.
The greatest gains will come when more cancer care is personalized and is matched the right time, the first time to patient tumor variability. Yet the ASCO and AHIP plan guidelines discourage and delay the adoption of such innovations.
The fact is, no one with ASCO or AHIP has discussed this math. I offered several times to be part of such discussions. No response. Lowell Schnipper who runs the ASCO value task force has written it’s not worth treating patients if it ‘only’ adds three months of life because “it is not a large enough benefit to trump the greater benefits to many that would have to be foregone to provide it.” Indeed, he believes the problem (of wanting to live longer) “ may be a particularly American one; other cultures do not seem to view the postponement of death by a few months” as important as Americans.
Has anyone covered the fact that the Wellpoint bonus program for cancer doctors measures value in the same way ASCO will measure it: efficacy, toxicity and cost. No mention of quality of life from the patient's perspective. Or how about that both Lee Newcomer and Schnipper said that the way to herd people into pathways that save money for health plans is to have the doctors develop the guidelines so that the plans are not accused of being self-serving (Schnipper and Newcomer's words, not mine). Shouldn't this be a subject of journalistic, if not congressional investigation? Shouldn't such cooperation -- with patients left on the sidelines -- be a source of concern?
Also, ask yourself: Should we take AHIP and critics of drug prices at their word because they don't get funding from pharma and ignore what I and others say because we get support from pharma? Does that mean that groups getting money from AHIP or health plans are to be believed? Is truth a function of where you get funding? Paul Offit did work for Merck on the rotavirus vaccine.. Does that mean that what he said about vaccines NOT causing autism should be discounted whereas Jenny McCarthy should be accepted.
When people attack where CMPI gets it support rather than engaging on the substance, it's a sign of desperation. I expect more of the same as the untenable and discriminatory assault on chronically ill patients continues.
"One of the major drawbacks of this type of treatment is that it’s extremely expensive. Insurance doesn’t pay for off-label use of cancer drugs—even if Champions’s scientists are able to prove they will work. Rose and Shapiro wouldn’t say how much they paid Champions to find the perfect drug. “Let’s just say it was a lot of money and I felt lucky that I have the resources to be able to do it,” says Rose. “There’s no doubt that part of me feels a little guilty that others don’t have the ability to do it.”
And...
"It has been said that the best way to survive cancer is to hold off dying long enough that a new treatment can be invented to save your life. That seems to be true now more than ever. Of course, for many cancer is still a death sentence. But Rose is a clear example that it doesn’t have to be. Through seven years of toxic chemotherapies and countless surgeries, he has never left his job (in fact, today he has three jobs—he’s the founder of San Francisco design firm SITELAB urbanstudio, a professor of practice in the Department of City and Regional Planning at the University of Pennsylvania and is running Urban Design+, another design firm, based in New York City). During his treatment, he and Josslyn even had a son, Ryder, now three and a half years old.
In many ways, Rose is living with cancer the way someone with HIV/AIDs would have shocked the world by doing so 10 years ago. The disease, once thought to be a debilitating death sentence, has become something that just needs regular care. According to Shapiro, “Before, when we were told there was only palliative care and they told us the best they could do was manage his disease, I thought that was a failure. But actually, it’s not a failure. You can live with disease in your body.”
Health plans, led by AHIP's Karen Ignagni are not only refusing to pay for cancer survival. And ASCO is enabling such rationing by developing an algorithm that determines 3 months of additional life is not worth spending money on. Or as Lowell Schipper, the head of the ASCO Value Task Force puts it, three months of life (using a $10000 cancer treatment) “it is not a large enough benefit to trump the greater benefits to many that would have to be foregone to provide it.”
It should be pointed out that in 2011, Schnipper remodeled his Maine summer home. The renovation cost $200,000 and took seven months.
When oncologists believe fixing up a second home is more valuable than 3 additional months of life, we have a real problem. Apparently the life of Evan Rose is worth less than Schnipper's hardwood floors.
http://www.ahipcoverage.com/2014/06/10/wow-this-drug-is-really-expens-look-a-squirrel/
The "FACTS" excreted by AHIP are in bold. The reality is in italics.
FACT: Astronomical prices for specialty drugs will blow up Medicare Part D budgets and force higher premiums for seniors
An analysis in Health Affairs last week found that the price of the important hepatitis C drug Sovaldi could increase the cost of Medicare Part D and premiums for seniors by 8%. From this one drug alone, seniors on Part D could see an 8% premium hike.
IN FACT the CBO and several economists have shown that $1 of new drug spending saves $7 in other costs. As for Solvadi, the $84000 (not $100K) treatment is a cure that saves 1 million lives and will reduce spending on liver transplants, hospital stays as well as reduce disability. National Viral Hepatitis Roundtable estimates that without any major changes in current testing practices, the cost of HCV care and treatment to Medicare will increase five-fold over the next 20 years, from $5 billion to $30 billion.
This one-time test, in combination with other targeted treatments, would result in identifying more than 800,000 cases and avoiding as many as 121,000 deaths
Assuming $100,000 value for each additional life per year, that's worth $1.5 million for every individual, meaning every healthcare dollar spent curing Hep C generates $17 of value to each patient, the cost is outweighed by the value of reducing the impact of this disease.
FACT: Astronomical prices for specialty drugs will devastate state Medicaid budgets and displace important priorities like education and infrastructure
One recent analysis highlighted on Vox illustrated that, because Sovaldi is so expensive, California could potentially spend more administering the drug for people on Medicaid than it does for K-12 and secondary education combined. Yes, you read that correctly.
In FACT : California spends $110 BILLION per year on K-12 and secondary education. There are 530,000 people living with hepatitis C in California. Even if all of these people received Solvadi (at a Medicaid discounted price of $60K) that would be a little over $3 billion.
FACT: Astronomical prices for specialty drugs put upward pressure on premiums for all consumers
At its core, the cost of health insurance is a reflection of the cost of health care. The skyrocketing prices that drugmakers are charging has a ripple effect throughout the system, raising premiums and increasing health care costs for individuals, families, and employers.
IN FACT: According to a Milliman study, stopping the shift of up to half the cost of new drugs for cancer, RA, MS, etc would cost AHIP companies a whopping 50 cents per member per month. http://publications.milliman.com/research/health-rr/pdfs/parity-oral-intravenous-injected.pdf
FACT: Health plans offer consumers a range of coverage options, including policies with lower cost-sharing
To distract from their unjustifiable pricing, drugmakers have latched onto distorted coverage comparisons that ignore the range of cost-sharing options consumers can choose from. Hey, anything beats talking about the actual price.
IN FACT.. See above. And if you don't believe me, read the lawsuit AIDS patients and the Naational Health Law Program filed against 4 of the largest AHIP insurers.
http://www.theaidsinstitute.org/sites/default/files/attachments/CQ%20HEALTHBEAT%20NEWS.pdf
FACT: Consumers have out-of-pocket limits that mean health plans and state and federal governments rather than patients are paying the vast majority of the cost of these stratospherically priced drugs
Pharmaceutical companies know that consumers’ out-of-pocket costs are capped under the Affordable Care Act, allowing them to ask for what amounts to a blank check from insurers and government programs. Not surprisingly, drugmakers are making the law work for them.
IN FACT: Many drugs once covered by AHIP plans are not covered under Obamacare if they are prescribed by out of network doctors. Also, many drugs are now NOT covered which means consumers -- the sickest consumers -- have to pay full freight. Yet AHIP could solve the problem with 50 cents per person.
BONUS FACT: Drugmakers have no straight-face explanation to justify the increasingly astronomical prices they have been charging for their medications
BONUS RESPONSE TO LIE: IMS data shows that new drug costs have risen about 5 percent a year. Co-pays and co-insurance costs for consumers have climbed to 40 percent in over half of Obamacare plans according to an Avalere Study.
http://www.phrma.org/sites/default/files/20140521_FINAL%20PhRMA_High%20Coinsurance%20and%20Tier%20Placement_Avalere%5B7a%5D_0.pdf
AHIP is hysterical over the fact that 35 states have required their members to cover new drugs at the same level they do old drugs. And now states are limiting the ability of AHIP plans to force patients to fail first on old medicines (translation: get sicker before we treat you and then talk about hospice instead) instead of using precise, personailzed treatments that work best the first time.
AHIP's pursuit of short term profits is understandable. It has tried to shift the cost on to consumers and blame onto drug companies. Why is AHIP trying to avoid paying for new medicines that save lives, reduce cost and increases productivity? Because it can save money short term by 'redlining' chronically ill patients and avoid having to take on such consumers altogether.
It wasn't supposed to work this way, but since the Affordable Care Act took effect in January, Norton Hospital has seen its packed emergency room become even more crowded, with about 100 more patients a month.
That 12 percent spike in the number of patients — many of whom aren't actually facing true emergencies — is spurring the hospital to convert a waiting room into more exam rooms.
"We're seeing patients who probably should be seen at our (immediate-care centers)," said Lewis Perkins, the hospital's vice president of patient care and chief nursing officer. "And we're seeing this across the system."
That's just the opposite of what many people expected under Obamacare, particularly because one of the goals of health reform was to reduce pressure on emergency rooms by expanding Medicaid and giving poor people better access to primary care.
Read the full story.
Hi-Yo Silver, away!
A new analysis from Avalere Health finds that consumers in exchanges receiving federal assistance to reduce their out-of-pocket costs may experience inconsistent reductions in spending depending on the plan they choose.
Specifically, the data show broad differences in how issuers amend plan designs to meet cost- sharing requirements for those receiving cost -sharing reductions (CSR). While almost all plans reduce deductibles and out-of-pocket caps in CSR plans, many plans do not lower cost-sharing for other treatments and services, particularly specialty drugs.
“Many people assume that the lowest-income exchange enrollees will have reduced cost-sharing across all services, but the reality is quite different,” said Caroline Pearson, vice president at Avalere. “While all plans must have reduced out-of-pocket limits for individuals earning less than 250 percent of poverty, how consumers will reach those limits differ significantly. For example, consumers may not experience reduced cost-sharing amounts for drugs or physician visits in many plans.”
All carriers that offer silver plans on the exchange must also offer silver CSR variations that have higher actuarial values (AV) for people who qualify for cost-sharing assistance. Individuals with incomes between 100% and 150% of the federal poverty line (FPL) receive the biggest reductions in likely out-of-pocket costs. Beyond requirements to lower maximum out-of-pocket caps , plans have broad discretion in how they meet the AV targets for CSR plans.
Notably, the vast majority—96% of 94% and 87% AV CSR plans—reduced deductibles to help meet new requirements. However, wide variation even exists among carriers that lowered deductibles. For example, the highest deductible ($700) among 94% AV plans analyzed is three times greater than the average ($220).
By contrast, a far smaller percentage of plans—including only 5% of 73% variations—reduced cost sharing for Tier 4 medications (specialty drugs). Indeed, a quarter of the 94% AV plans (the plans providing the highest level of cost-sharing assistance) had coinsurance of greater than 20% on the specialty tier.
Notably, Avalere also found that average maximum out-of-pocket limits in CSR plans are lower than those required by the Affordable Care Act. Specifically, among 87% AV CSR plans, the average out-of-pocket limit is $450 (or 20%) lower than required, while among 94% AV CSR plans, the average out-of-pocket maximum is $1,140 (or 22%) less.
“Issuers will continue to have flexibility in how they design cost sharing reduction plans in 2015,” said Dan Mendelson, CEO and founder of Avalere Health. “Looking ahead, consumers who qualify for cost-sharing reductions should look closely at how the plan benefit is structured because it could have a major impact on their actual out-of-pocket costs.”
This analysis was funded by PhRMA. Avalere maintained editorial control over the content of the analysis and release.
Methodology:
Avalere analyzed the 11th version of the Department of Health and Human Services (HHS) Landscape file available on HealthCare.gov. The file contains details on individual and family premiums and benefit designs for plans across the 34 states in the Federal Facilitated Exchange (FFE). The 34 states in the federally-facilitated marketplace include: Alaska, Alabama, Arkansas, Arizona, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, and Wyoming. This analysis focuses solely on this data file and, therefore, does not reflect plans offered in any state-based exchange.
The file contains 5,800 total silver plans, including standard silver plans as well as the required “silver plan variations.” Drug coverage data in the HHS Landscape file are structured into four formulary tiers; therefore, for plans that have fewer or more than four formulary tiers, the data in this file may not align with the plan’s true formulary structure. The accuracy of all analysis is limited by the accuracy of the data included in the Landscape file itself.
Although Avalere analyzed and included a number of details about deductibles, we did not consider whether a person needs to meet a deductible when analyzing cost-sharing categories to conduct our analysis (e.g., if coinsurance is 10% after meeting a $1,000 deductible, when analyzing costs for the service, Avalere used the 10% coinsurance amount). Plans that noted that there was no charge, or no charge after the deductible was met were excluded. Amounts are rounded to the nearest dollar or percent.
A substantial portion of silver plans indicated in the Landscape file that their benefit design included a $0 drug deductible. An examination of a subset of the Summary of Benefits and Coverage (SBC) documents from these plans confirmed that two-thirds of the sample of plans actually did not require drugs to be subject to a deductible. The remaining third could not be validated with the data from the plan’s SBC.
View Avalere's full report here.
WASHINGTON DC, June 4, 2014 – In a letter submitted today to the U.S. Food and Drug Administration (FDA), the National Organization for Rare Disorders (NORD) urged Commissioner Margaret Hamburg to give serious consideration to the concerns of the rare disease community when setting policy regarding official names for biologics, including biosimilars.
With over 7,000 rare diseases identified and 30 million Americans affected, the patient population represented by NORD is extraordinarily heterogeneous, the letter notes. Without thoughtful and consistent naming protocols for biologics, there is the potential for significant confusion among treatment options and increased adverse events, both of which could jeopardize patient safety. Distinguishable naming of all biologics is imperative for health care professionals to deliver the degree of customized care that is routinely required for patients with complicated, uncommon and less well-studied diseases.
“Every patient deserves the care best suited for their medical situation and most likely to give them the best outcomes,” said NORD President and CEO Peter L. Saltonstall. “Biologics are often the most advanced and effective treatments for patients we represent and everyone in the treatment continuum should be able to readily identify the specific drug product a patient was given.”
The letter raises a number of concerns specific to rare disease patients. Rare disease patients usually have unique treatment courses and, while similar medications might work equally well, such a judgment can only be made through tracking of outcomes made possible through distinguishable names.
According to the letter, distinguishable names for biologics would:
* Support the medical community’s vital post-approval learning curve regarding which medicines are best for their rare disease patients;
* Support surveillance and tracking of adverse events given that rare disease patients often do not respond to medications in the same way as other individuals might; and
* Reinforce a critical distinction in the biosimilars law between biosimilars (similar not identical) and interchangeable biosimilars (similar but demonstrated to have comparable clinical results).
Next up: Vote at the AMA House of Delegates.
The FDA has publicly released a huge amount of data on drug side effects that it hopes will lead to new applications and research.
Under its open FDA project, the agency has released more than 3 million reports on adverse drug events and medication errors recorded between 2004 and 2013. These kinds of reports were only available before through lengthy Freedom of Information Act requests.
Before releasing the information, the agency removed patient identification and other sensitive information. It has also been formatted to let researchers, mobile applications and Web developers easily analyze the data and present it in a way that can help improve how people take drugs.
Eventually the agency plans to release more reports on recalls and labeling, as well as other information it thinks can be useful to developers and researchers.
The move to make medical data more transparent isn’t limited to the FDA. Several drug makers working with the National Institutes of Health have begun releasing clinical trial data in a limited fashion to help find new uses for old drugs.
Obvious by its absence is any mention of greater clinical trial transparency. But that's a whole other can of worms. (For more on this issue, see "Cry Havoc, and let slip the Dogs of Data Transparency.")
A good next step would be for the FDA to be the coordinating body for all relevant e-tized information from both public and private sources. But that’ll take resources. It would be money well spent.
Speaking of transparency – how about an OpenFDA program for the agency’s risk/benefit decision-making process?
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.
