Latest Drugwonks' Blog
Clearly, the practice of medicine, perhaps better described as the delivery of healthcare, is undergoing a radical, permanent change, at least for the foreseeable future. After all, we are only a few weeks into the first year of ObamaCare, and already HHC, one of the largest hospital corporations in the country, has decided to hold their physician employees financially responsible for the mandatory changes outlined by CMS. The complexity of these changes makes their adoption into current practice a daunting task for many physicians.
The simple fact is, that the future of medicine looks very different than it did when many of today’s doctors started medical school, even for those who have graduated in recent years. For those who entered the field to treat patients, cure disease and make a real difference in the lives of others, the current tasks that consume much of their time and energy are carrying them further and further away from that goal. The optimists in the field would like to believe that pay-for-performance is simply a resetting of the status quo, which will take considerable time and effort, but ultimately benefit our profession and our patients in the long term.
I am hesitant to agree with this view for two reasons, among others. First, I believe that many physicians are already at or near capacity in terms of their ability to deliver care, both in terms of organizational resources, and personal time and energy. Many individual and small-group practices simply do not have the resources to understand and implement the constantly changing mandates from CMS. Therefore, when you hand them a forever evolving checklist of arbitrary measures that they must follow in order to be reimbursed properly, you only increase confusion and frustration, and do little to impact productivity or foster a system that delivers better care.
Secondly, for any physician who sees their reimbursement cut by providing “sub-optimal care”, as deemed by CMS, what is to stop them from refusing to serve their sickest, most chronically ill and frequently hospitalized patients? In so doing, they raise the “quality” of care they provide, and lower the cost at the same time (they will not be responsible for those sick patients when CMS evaluates them the next year). Such a reaction to pay-for-performance would only further accelerate a current trend in medicine, which is seeing many physicians refuse to accept new Medicare patients.
It is impossible to forecast how pay-for-performance will ultimately impact the quality of care we provide, and the cost at which we do so. But one thing is certain; the job of physicians providing that care becomes more difficult every day.
Read the full piece here.
Small is Big.
Bob Temple said he "would like to see more" comparative effectiveness trials for symptomatic treatments to help identify potential responders. In particular, Temple said trials that randomize non-responders to a drug to receive both that drug and an alternative drug have "a lot of potential" but are almost never done.
"For example, you could take people who don't respond to a migraine drug and randomize them back to a new migraine drug, the old migraine drug the one they didn't respond to, and a placebo. If it's true that there are individual differences that are important, then the new drug ought to be able to show its advantage over the drug that didn't work," he wrote in a post on FDA's From a Clinical Perspective blog.
When asked whether institutional review boards (IRBs) would approve such trials, Temple said there is no ethical issue in an informed patient. He added that such trials would not be done for indications where "not working would be dangerous."
This seems to jive with what Dr. Joe Selby (PCORI’s executive director) told me the other day – that he believes PCORI should focus on funding “narrow” clinical trials aimed at smaller, more targeted populations, that PCORI's mission is to ensure that CER helps to advance the cause of personalized medicine and “the right treatment for the right patient at the right time.” Bravo.
If Joe Selby can be the Good Witch of Comparative Effectiveness Research, so much the better. I think he’d look lovely in ruby slippers.
As would Bob Temple.
"YONKERS, N.Y., Jan. 30, 2013 /PRNewswire-USNewswire/ — In its March issue, Consumer Reports shines a light on oversold cancer screenings that might confuse rather than clarify. The report evaluates eleven cancer screenings, finding that eight should be avoided.
The report, available online at www.ConsumerReports.org and wherever magazines are sold, notes that the Ratings are for people who are not at high risk and without signs or symptoms of cancer
Screening tests for cervical, colon, and breast cancers are the most effective tests available, according to Consumer Reports’ first Ratings of cancer-screening tests. But most people shouldn’t waste their time on screenings for bladder, lung, oral, ovarian, prostate, pancreatic, skin, and testicular cancers. The Ratings are based mainly on evidence-based reviews from the U.S. Preventive Services Task Force, an independent group supported by the Department of Health and Human Services."
Oversold? And given that cancer is now the leading form of death, and that treatments are increasingly targeted to cancer causing mutations that can be detected earlier, who is not at risk? Should we wait until Obamacare autocrats determine what tests should be paid for? Will people actually pay Consumer Reports to peddle medical malpractice?
I’m in Riyadh, Saudi Arabia where I just spoke at the first Saudi Quality Forum (sponsored by King Saud University). I also had the opportunity to meet with the leadership of the Saudi Food and Drug Authority (SFDA) -- which is also the national reimbursement agency. (And no product gets licensed without first concluding price negotiations.)
And you thought FDA swings a big stick.
My suggestion to their executives is that they form an Office of Policy and Planning – and that one of the first items on the agenda be chairing a regular meeting of industry (both innovator and generic) and academia to address issues of common interest including API and excipient quality, biosimilars (specifically the issues of biosimilarity and interchangeability), 21st century pharmacovigilance, generic interchangability, and other issues that fill the Arabian regulatory gulf -- like re-registration.
The SFDA aspires to be not only the gold standard for the region, but also a world-class regulatory agency. But to do so they must recognize their responsibility to be both regulator and colleague to industry and an innovation enabler. Sound familiar?
My favorite sound-bite from the conference came courtesy of the SFDA’s Mohammed Dahhas (Executive Director of Inspection and Law Enforcement, Drug Sector): On the issue of quality by design, “Quality is the magic key.”
My favorite new concept came from Accenture’s Pierre Anhoury, who introduced the conference attendees to notion of “value vigilance” – a new way to view post-approval value-based reimbursement via pharmacovigilance, quality of life, therapeutic benefit, and pharmaco-economic impact. Maybe we should call it Phase 4.1.
(Have a look at Anhoury’s new white paper on the topic, Approval is Nothing: Why Pharmaceutical Companies Need a Value Management Operating Model.)
Wouldn’t it be NICE to bury the QALY in the sands of Saudi?
"We are thankful to all of you who have prayed for Michal and expressed your support in other ways. Here is another opportunity for those interested.
On March 3, 2013 both our sons-in-law, Ben Coleman (Michal’s husband) and Sean Wasserman, will be participating in Cycle for Survival, the national, indoor team cycling event that has raised more than $20 million in support of life-changing research on rare cancers at Memorial Sloan-Kettering Cancer Center, one of the world's premiere cancer research institutions.
100% of the funds raised through this ride go directly to MSKCC's research of rare cancer, like Synovial Sarcoma, making us feel very personally connected to this cause. With your help, we can move closer to finding out how to cure cancers like the one Michal is battling right now.
The 2012 ride donations were already put to work in twenty-eight different MSK labs and clinics – targeting a wide range of rare cancers. This progress – and the hope it brings to patients and their families – is only possible because of thoughtful contributions from people like you! We are asking you to join the battle and make a gift to support our ride against cancer. The link below will bring you to our fundraising page, where you can make a tax-deductible online donation."
http://mskcc.convio.net/site/TR/CycleforSurvival/AG_Cycle_Event?pg=team&fr_id=1818&team_id=26100
How many times have you read, “The FDA is not required to follow the advice of its advisory panels but usually does."
Except when it doesn’t.
Recently an agency advisory panel voted against recommending making oxybutynin transdermal patch (Oxytrol) available over-the-counter (OTC) for overactive bladder (OAB) in women.
In their 5-6 vote, panelists on the FDA's Nonprescription Drugs Advisory Committee noted their concerns that women would use Oxytrol thinking they had OAB when they really had some other ailment that needed a physician's treatment. They also were concerned about men using the product off-label.
Some also were worried about the high amount of potential misuse -- whether it was by patients who did not have indications for proper use, or those it was meant for that didn't use the product correctly.
Well, today the FDA ruled that a patch containing oxybutynin (Oxytrol) for controlling overactive bladder may be sold over-the-counter for women 18 and older.
Men will continue to need a prescription for the drug, the agency said. The OTC product will be marketed by Merck as Oxytrol for Women.
In considering an Rx-to-OTC switch, the FDA looks to see whether patients can use the product safely without the oversight of a physician or pharmacist. This includes ensuring that the right patients use the drug in the appropriate way ("safe use"). The agency is not evaluating the risk-benefit of the product, since that was done earlier when it was approved as a prescription drug.
But, considering all of the issues surrounding this particular switch (conditions can cause symptoms similar to those of OAB, including urinary tract infection, bladder malignancy, pregnancy, prostate disease, and uncontrolled diabetes mellitus), AdComm panelists (who voted no) said those conditions need a physician's care, and an OTC oxybutynin could delay treatment. Shouldn’t the FDA have asked Merck for a “safe use” plan – in addition to the age restriction? Sort of REMS for OTC products?
Note to FDA – there’s an app for that.
Drug companies and medical-device makers would be forced to publicly disclose any money paid to doctors under new U.S. regulations designed to make patients aware of conflicts of interest that may affect their health.
According to CMS, the Sunshine Act’s final rule will be released “soon.”
Expanded public disclosure, according to an interesting Bloomberg article is likely to focus greater scrutiny on physicians serving on FDA advisory panels.
Doctors who now sit on FDA advisory panels must inform the agency about conflicts of interest. The FDA determines when a waiver for a financial conflict may be necessary and otherwise keeps arrangements between doctors and companies secret, even from other panel members.
Peekaboo, Sid Wolfe sees you.
PMLive reports:
Pharmaceutical companies may have enthusiastically embraced Twitter, at least at a corporate level, but local European regulators have proved somewhat more reticent.
The European Medicines Agency (EMA) led the way by signing up to the social network in 2010, but few local bodies have followed suit.
One of those that did was the Medical and Healthcare products Regulatory Agency (MHRA), and the UK regulator has just expanded its use of Twitter and launched three new accounts on the social network.
One of these is a corporate account, the use of which tends be pharma’s first step into social media.
The MHRA says its new corporate Twitter presence, @MHRAgovuk, will be used to promote general information and updates, while two other accounts will focus on safety alerts and information about medical devices and medicines.
The regulator has been cautious in its approach to Twitter to date, launching dedicated accounts in 2011 for first herbal remedies and then its press office, the account names of which have been simplified as part of its Twitter expansion.
It remains to be seen how well the use of separate accounts for press and corporate purposes will work, given the potential for subject overlap between the two.
But the use of new, separate accounts for medicines and medical devices seems logical, given the differences in audience for a recall of Merck Sharp & Dohme’s Tredaptive versus that for a mass spectrometer.
• Links to all of the MHRA's Twitter accounts, and many more from regulators, industry associations and pharma companies, can be found in the Twitter section of the Digital Handbook’s pharma social media directory
The Drug Enforcement Administration has once again asked the FDA to consider tightening prescribing and other rules on hydrocodone drugs.
Proving, once again, that the DEA doesn’t understand the problem. Denying access to patients in pain (the unintended but obvious consequence of up-scheduling) does nothing to stop those who provide hydrocodone – via inappropriate prescribing or illegal means.
The FDA will hold hearings tomorrow and Thursday to consider whether to move hydrocodone products from schedule III to the more highly regulated schedule II class under which narcotics such as OxyContin (oxycodone) fall. In a briefing document released as background material, FDA scientists said that although "patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction."
This is regulatory-speak for not wanting to change the classification.
CDER Deputy Director Dr. Doug Throckmorton said an analysis conducted internally by scientists at the agency does not reflect the FDA's "official stance." He said the agency will refrain from making recommendations until after it has reviewed testimony and received a recommendation from the independent advisory committee, which scheduled the two-day hearing.
This is regulatory-speak for, “we know what we want to do – but we want to solicit informed opinion."
Please step up to the microphone and state your name.
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.
