On November 12, 2013, the American Heart Association (AHA) and the American College of Cardiology (ACC) disrupted the cardiovascular disease (CVD) universe by issuing four new guidelines. The guidelines depart from past efforts because the relevant federal agency, the National Heart, Lung, and Blood Institute (NHBLI), did not lead development. NHBLI now ‘sponsors’ guideline development, but has deferred actual writing and publication to private groups.
No word on when long-awaited companion blood pressure guidelines will emerge. If the blood pressure guidelines look anything like these cholesterol guidelines, then all rational arguments about cost containment will effectively come unhinged.
The guideline release was well orchestrated, not unexpected in organizations so well-funded by the pharmaceutical companies. They are the population that stands to benefit the most from what Alan Cassels, author of Selling Sickness and Seeking Sickness, which both seemed to anticipate moves like this, calls “statinization.” Fortunately, not everyone was drinking the “treatment today, treatment tomorrow, treatment forever” Kool-Aid; contrarian physicians believe that the guidelines simply lowered the therapeutic bar without clear evidence that doing so will improve outcomes, an ironic observation given that this is supposed to be about primary prevention.
The contrivance of simply altering a definition and having the subsequent area under the curve of healthy people who require treatment expand to include, oh, say 30 million more Americans is a merger-and-acquisition coup for pharma that would make Gordon Gekko blush.
Lowering the therapeutic bar will increase health care spending as physicians write more prescriptions and see more patients more often, certainly to monitor liver health, and probably for the side effects that cause double digit percentages of patients to stop and are routinely underreported in studies sponsored by the industry.
It also gives patients false security by promoting the belief that the heartily recommended drugs – statins – will provide a “cure,” a clinical get-out-of-jail-free card, which will surely diminish enthusiasm for lifestyle-based approaches to prevention that are free but unfortunately not reimbursable. And, as Abramson and Redberg note in their New York Times essay, the enunciated strategy will require perpetual treatment of 140 people to forestall 1 heart attack. Many of these people will now live long enough to experience “disease substitution,” allowing them to die of cancer or dementia.
The most important element of the new guidelines, however, is the shift away from pursuit of hard targets (get total cholesterol below 240 and LDL below 180) to a risk-based approach (for people without clinically evident disease), in which the therapeutic goal is to medicate non-diseased adults aged 40 to 75 who have an estimated 10 year risk of developing heart disease greater than 7.5% (down from 10% risk over 10 years). Overall, this necessary and overdue shift properly emphasizes CVD risk as a constellation and exposes our cultural tendency to seek or initiate treatment because of a single adverse attribute, which has led us to waste a fortune chasing clinical ghosts.
Continue reading “The Statinization of America”
Filed Under: OP-ED, THCB
Tagged: American College of Cardiology, American Heart Association, Guidelines, NHLBI, Statins
Nov 14, 2013
Health care costs too much in the United States. One key problem is gold-plating of services driven by physicians’ fears of lawsuit for failure to do everything possible for patients. A notable example of such overutilization is increasingly routine ordering of advanced imaging or other tests. Reliable, evidence-based clinical guidelines promise to address low-value utilization by authoritatively stating standards of good care in advance.
Some thought leaders among Democrats seek to use guidelines to side step the routinized political battles over malpractice reform. Republicans have been saying that defensiveness and other problems justify caps and other limits on medical liability. Belittling defensiveness as a problem, Democrats have defended and promoted liability as an incentive for good care.
Defensiveness is a problem, acknowledge proponents of guidelines to reform liability. But it can be fixed simply by legislating that adherence to reliable guidelines constitutes a “safe harbor” against lawsuits for failure to do more. Safe harbors would remove the motivation for defensiveness and also any need to accept Republicans’ caps and other limits. Given the political stalemate in Washington, the idea is worth thinking through.
Good guidelines are a good idea, especially to improve quality of care, which is their main policy driver. And, because guidelines hold promise for cutting wasteful defensiveness, they have superficial appeal as a liability reform. However, practical feasibility limits the reach of safe harbors, as explained in a recent policy brief from The Urban Institute for the Robert Wood Johnson Foundation.
Continue reading “Clinical Practice Guidelines as “Safe Harbors” against Malpractice Claims”
Filed Under: THCB
Tagged: Defensive Medicine, Guidelines, Malpractice, Overutilization, Safe Harbor
Jul 22, 2012
Universal treatment standards will be the basis of future medical care. In oncology, a leading organization for the development of such guidelines is the National Comprehensive Cancer Network (NCCN). This national consortium of 21 National Cancer Institute designated cancer centers publishes state of the art recommendations. Modified continuously, these are internationally respected guidelines and cover more then 97% of cancers.
The 17th Annual NCCN Conference was held in Hollywood, Florida last month. Cancer guidelines were updated in several significant ways.
The general movement of the last 20 years has been to reduce the amount of surgery for breast cancer. The NCCN recommends that during breast saving surgery (lumpectomy) the surgeon test the first lymph node (“sentinel”). If there is no cancer in the first one or two nodes, then no more nodes need to be removed. The NCCN also stated, that if breast cancer patients have small cancers and normal blood tests, they do not need a bone scan, or CT scan.
In lung cancer patients, several procedures received new support. It is recommended that doctors use ultrasound-guided biopsy to sample lymph nodes in the middle of the chest (mediastinum) instead of surgery. The new guidelines also support the use of non-invasive surgery (Video Assisted Thorascopic Surgery, VATS) instead of open surgery to treat lung cancer. The use of VATS for lung cancer has increased more than 300% in recent years. The pathologic name for an increasingly common form of lung cancer was changed. Formally, called “bronchioalveolar”, it will now be called “adenocarcinoma in situ.” Finally, the NCCN emphasized the need for accurate genetic testing for “ALK”, before using the drug that targets this mutation, crizotinib.
Continue reading “Rethinking Cancer Guidelines”
Filed Under: Uncategorized
Tagged: Cancer, Guidelines, Lung cancer, Melanoma, Ovarian Cancer, Yervoy, Zelboraf
Apr 27, 2012
The American Board of Internal Medicine (ABIM) and nine other professional medical societies announced that doctors should perform 45 tests and procedures less often than currently done because there is no good medical evidence that they add any value. Specifically, a xray or other imaging for low back pain in an otherwise healthy individual or an EKG as part of a routine physical, just add a lot of unnecessary cost to the health care system as a whole and don’t provide doctors or patients any meaningful information that would be helpful in improving health or arriving at the right diagnosis and treatment.
The ABIM partnered with Consumer Reports to create a new campaign called Choosing Wisely and are joined also by collaborators like employers (the National Business Group on Health, the Pacific Business Group on Health), hospital safety (the Leapfrog Group), and labor unions (SEIU). The mission is simply to have doctors and patients deliver and receive care that is medically necessary, based on evidence, avoids harm, and minimizes duplication.
The real question is – will it work? Will doctors follow what their professional societies recommend?
Though Choosing Wisely is a laudable attempt to make medical care better quality, the truth is doctors won’t likely follow these guidelines from their medical societies. If it was that easy, we would not have this problem! Even today, it is still a challenge for the medical profession to have all doctors wash their hands correctly every patient every time, get immunized routinely against influenza, or even not to prescribe antibiotics for coughs, colds, and bronchitis due to viruses! What is more disturbing is that doing these basic interventions did not impact a doctor’s income. Some on the list of Choosing Wisely, however, will.
Continue reading “Will Doctors or Patients Bend the Cost Curve?”
Filed Under: Physicians, THCB
Tagged: American Board of Internal Medicine, Choosing Wisely, Costs, EKG, Fee-for-service, Guidelines
Apr 6, 2012
By DAVID WILLIAMS
An Archives of Internal Medicine article (Conflicts of Interest in Cardiovascular Clinical Practice Guidelines) is getting a lot of notice this month. In essence, many of the physicians who develop guideline that influence practice patterns and payment decisions have conflicts. The authors recommend only allowing those without conflicts to write the guidelines.
This isn’t a new issue. In 2006 I wrote a piece (Another dirty little secret is out in the open) and am reposting it below because it’s timely:
A year ago in Time to deal with medicine’s dirty little secrets?, I wrote about a variety of practices that are relatively well-known in the health care field but would be shocking to outsiders. Industry often takes the blame for “aggressive marketing tactics,” and no doubt some of that is deserved. But physicians are also culpable.
The open secrets include the ghostwriting of journal articles by industry sponsors, physicians and academic medical centers holding ownership stakes in companies whose products they are researching, the clinical role sometimes played by orthopedic sales reps, and perhaps the most egregious example: physicians who set guidelines having financial relationships with the companies that benefit from how those guidelines are set.
Now we have a new example, which is even more serious than usual. A recent New England Journal of Medicine article blames Eli Lilly for overzealous promotion of Xigris. According to the Boston Globe:
Eli Lilly and Co. funded medical guidelines created for the treatment of [sepsis] in an effort to boost sales of a drug with questionable benefits. The allegation was made by senior scientists at the National Institutes of Health. [They] said Lilly tried to shape the guidelines for use of the drug Xigris by sponsoring a three-pronged marketing campaign
The first two phases are by now almost standard practice in the industry:
- Lilly paid a task force to spread the word that hospitals were rationing Xigris because of its cost, which forced docs “to decide who would live and who would die”
- Lilly “orchestrated” the development of practice guidelines to treat sepsis that called for early use of Xigris (an example of the phenomenon I have described before)
But then Lilly allegedly took a third step, which was a little shocking even to me:
Now, Lilly is sponsoring lobbying efforts to turn the guidelines into quality standards. Hospitals that follow such quality measures receive higher payment from insurers.
What’s happening here? Basically, an influential group of doctors is being lazy and greedy, and Lilly is enabling their behavior. The doctors put their fingers in the cookie jar and Lilly keeps restocking it. The public is paying for the cookies –in the form of higher product sales and sub-optimal health care– and should get fed up!
I have no problem with companies using legal means to promote their products, even if their tactics are “aggressive.” They owe it to their shareholders to maximize return on investment. But it isn’t in their long-term interest to push things as far as the medical profession often lets them.
Industry leans on the reputations of individual physicians (aka “key opinion leaders”), medical societies (aka guideline writers), and journals to legitimize their marketing messages. It’s up to the medical profession to scrutinize industry claims and issue independent guidelines and quality standards. Sometimes these claims hold up and deserve to be propagated. Sometimes they don’t. If the docs and journals don’t do their jobs they deserve to lose credibility.
It’s hard to know the extent to which medical guidelines are already corrupted. The situation is a bit like the incident when the Chinese President’s plane was refitted. In the process of fixing up the plane someone inserted a bunch of listening devices (presumably at no extra charge). When the Chinese checked out the plane and realized it was bugged they had to rip the whole thing up. That’s something like what is going on within the major payers. They’ve stopped treating journal articles and guidelines as objective and have started doing their own analyses. But do we really want to leave health care decisions just to them?
Here’s some free advice to the different players in health care:
- Industry: Feel free to market your products and services aggressively, but don’t take things too far. If you do you’ll end up killing the goose that lays the golden eggs. No one will trust doctors, guidelines or journals anymore
- Physicians: Remember that pharma and device companies are not stupid. If they spend money supporting your research or sending you to conferences or sponsoring continuing medical education it’s because they expect to get a return on their investment. It’s awfully hard to remain objective in such instances. Your job is to adopt the best medical practices and put the patient first –sometimes that requires expensive new treatments and sometimes old, cheap standbys are better
- Payers: Go ahead and challenge the objectivity of journal articles and guidelines. On the other hand, don’t pretend that low cost is always synonymous with best treatment. Expect physicians to keep you in line on that.
- Patients: You need to look out for yourself. Find a good, honest physician. Take a look at who’s sponsoring the educational materials you receive. Ask your physician about alternative treatments and do some research yourself
Filed Under: Physicians
Tagged: Archives of Internal Medicine, cardiology, Conflict of interest, Eli Lilly, Guidelines, NIH, Quality
Feb 24, 2011