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The Holy Grail of Evidence-Based Medicine

Thu, 28 May 2009 16:16:00 GMT

I am probably more optimistic than most healthcare professionals about the value of evidence-based medicine. To me, it is a tool that can be used or misused to achieve certain goals. Misuse doesn't mean the tool should be tossed out—it just needs to be policed.

As the former medical director for several health plans and for a large hospital, I used EBM to develop medical policies and make decisions about benefit coverage. Program participants felt that EBM made the decision-making process rational, objective, and based on facts, rather than on personal anecdotes, expert opinion or “that's the way we've always done it” methodology. Misuse generally occurs when there is profit or prestige involved. If the evaluation and funding for medical research (the basis for EBM) were moved to a more regulated environment, I believe the instances of misuse would decrease and be easier to spot.

The new administration has made healthcare a major focus and supports the idea of evidence-based medicine. Congress has approved President Obama's proposal to spend $1 billion to support comparative effectiveness research. The goal is to identify which medical products and procedures are most effective—and ultimately improve healthcare and decrease unnecessary spending.

The use of comparative effectiveness research risks cost-based restrictions. However, we may be headed for that now, but without clinical and value outcomes added to the mix. It's disturbing to watch when peer-reviewed research is sullied by undisclosed financial ties, whether they influenced the research or not. This appears to create a fraudulent base for clinical decision making.

Another danger for evidence-based medicine is the “R” word: Rationing. This issue is always raised as a red flag when EBM or comparative effectiveness is discussed, but the argument is a red herring. Rationing happens around the world because every country, except the United States, has confronted the reality that unlimited demand cannot be balanced with limited resources. Those countries have decided how to allocate their limited resources to best serve their citizens and the result is the “queue system,” or the wait for a limited resource.

Congress has also taken steps to help ensure that care cannot be rationed. In fact, the American Recovery and Reinvestment Act of 2009 stipulates that comparative effectiveness research cannot be used to “mandate coverage, reimbursement or other policies for any public or private payer.”

Evidence-based medicine doesn't cause rationing—rationing is the result of government policy decisions. Instead, EBM is a tool used to decide how much of a resource is needed and how patients are going to access it, based on medical need and value received. Linking rationing with EBM is a political trick used by those who don't want to be held accountable for the reality of limited resources and the necessity of telling someone no.

In this country, we routinely tolerate de facto rationing every day by limiting access to medical services based on ability to pay—a form of social justice that most other countries find incomprehensible. Just try getting access to a liver transplant is this country if you are self-employed, can't get health insurance, but make too much money to get on Medicaid. It can't be done.

The one danger of using EBM is the failure to realize that most of the things we do in medicine are not supported by good, solid medical evidence. The key policy behind EBM is a commitment to allowing practitioners to continue their current practices until EBM supports a change. We can't simply declare that we're going to stop doing things because they don't have an EBM basis because that would wipe out most of what we do. I think that key declaration of principle would take away most of the anxiety for most practitioners, but mostly on a generational basis. You can't do much about folks who are:

Too far into their careers to deal with change
Have a financial stake in resisting/opposing change

My experience with setting and administering medical policy for several million enrollee-years tells me that approximately 20% to 25% of the annual healthcare dollar is wasted on redundant, low-value, useless or even harmful healthcare services. A well-organized, refereed approach to EBM would help with this problem, but it would be a long-term effort. The current administration is correct in stating that we can probably cover all of the 47 million uninsured Americans with the savings achieved by EBM, but they are far too optimistic about how long it will take to achieve that goal.

Applying evidence-based medicine or comparative effectiveness to medical policy need not be a foreign concept. My current employer helps hospitals improve their financial and clinical performance and does that quite well. That doesn't mean we contract for the cheapest items, but instead we choose items that provides the greatest value at the lowest cost. We also look at appropriate utilization and whether there are opportunities for clinical improvement. That is what EBM is all about.

That logic can prevail if applied more broadly. I'm only one physician, and many of my colleagues share my viewpoint. Nevertheless, healthcare won't get better unless doctors engage in serious discussions about how to change it.

Mark Hochstetler is vice president of clinical affairs at VHA Inc. He can be reached at mhochste@vha.com.

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Vermont strengthens gift ban

Wed, 13 May 2009 04:41:00 GMT

The Vermont legislature is getting tougher on the pharmaceutical industry by passing a bill that tightens up the state’s existing gift and payment disclosure law.

The new law closes a trade secret loophole that allowed pharmaceutical companies to submit most data in aggregate form. The bill also expands the disclosure requirement to medical device and biologics manufacturers.

Read more about Vermont's updated gift ban.

No class action status in CA Vioxx lawsuit

Wed, 13 May 2009 04:39:00 GMT

Los Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs seeking to sue Merck for its withdrawn painkiller Vioxx.

Chaney said in her ruling that trying plaintiffs’ claims would require an examination of each proposed class member’s medical needs and history, which Merck successfully argued would be unfair, according to a company statement.

Read more about Chaney's decision in the Vioxx lawsuit.

Editor's Note: Final issue of Device Regulation Alert today

Sat, 09 May 2009 04:34:00 GMT

HCPro is sorry to announce that this is the final issue of Device Regulation Alert. We thank you for being a loyal subscriber.

If you are interested in information about customizable, compliance e-learning courses for sales and marketing staff, please contact Maureen Croce at 866-464-2776 or mcroce@hcpro.com.

Device maker settles allegations it failed to disclose payments to physicians

Sat, 09 May 2009 04:31:00 GMT

Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement with the New Jersey Attorney General (AG) to resolve allegations the company failed to disclose financial conflicts-of-interest among doctors who conducted clinical testing on its products, according to the AG.

Disetronic Medical Systems recalls insulin pumps

Sat, 09 May 2009 04:29:00 GMT

Disetronic Medical Systems issued a recall for its ACCU-CHEK Spirit insulin pumps with serial numbers from SN02119552 through SN10006093 because the “up” and “down” buttons are potentially defective, according to a company release.

Patients use the pump’s “up” and “down” buttons to change the program in the menu or to administer additional insulin. If the buttons do not function, users may not be able to change any programmed setting on the pump.

Disetronic will replace pumps within the affected serial numbers that have intermittent or complete loss of function of the “up” and/or “down” button. Disetronic discovered the problem through the company’s normal quality control monitoring process.

FDA sends warning letter to Nidek Medical Products

Sat, 09 May 2009 04:26:00 GMT

Nidek Medical Products failed to properly document complaints about the company's oxygen concentrators, according to an FDA warning letter.

The FDA said the company failed to evaluate complaints properly to determine whether they should be reported to the FDA, and did not conduct adequate investigations of complaints, including one incident involving a patient’s death.

IOM calls for end to industry support

Sat, 09 May 2009 04:24:00 GMT

The Institute of Medicine (IOM) became the latest organization to call for an end to medical device industry support for academic medical centers, journals, and professional societies.

The IOM wants entities engaged in health research, education, clinical care, and development to establish guidelines for accepting industry support and to strengthen conflict-of-interest policies, according to an IOM report.

Congress should also require medical device companies to publicly disclose payments to physicians, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine, the IOM said.

Editor's Note: Publication of Pharma Compliance Alert to end May 13

Wed, 06 May 2009 04:54:00 GMT

Next week’s issue will be the final issue of Pharma Compliance Alert. We thank you for being a loyal subscriber.

If you are interested in information about customizable, compliance e-learning courses for sales and marketing staff, please contact Maureen Croce at 866-464-2776 or mcroce@hcpro.com.

Ranbaxy recalls Nitrofurantoin

Wed, 06 May 2009 04:51:00 GMT

Ranbaxy Laboratories issued a voluntary recall for all 100 mg Nitrofurantoin Capsules currently on the market in the United States, the company announced.

Only some lots of Nitrofurantoin do not conform to approved laboratory specifications, but the company decided to recall all of the capsules. Ranbaxy said the capsules are unlikely to produce any serious adverse reactions, but may increase nausea and vomiting.

Michigan False Claims Act qualifies for additional recoveries

Wed, 06 May 2009 04:49:00 GMT

Michigan’s Medicaid False Claims Act meets the requirements of the Deficit Reduction Act of 2005 (DRA) and the state is entitled to an additional 10% of false claims recoveries, according to the OIG.

Under the DRA, each state with a False Claims Act that is at least as effective in facilitating and rewarding qui tam actions as the Federal False Claims Act in protecting state Medicaid funds is entitled to an extra 10% of fraud recoveries from those actions. For the state to receive the additional money, the OIG must approve the state’s False Claims Act.

IOM calls for end to industry support

Wed, 06 May 2009 04:46:00 GMT

The Institute of Medicine (IOM) became the latest organization to call for an end to pharmaceutical industry support for academic medical centers, journals, and professional societies.

Congress should also require pharmaceutical companies to publicly disclose payments to physicians, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine, IOM said.

Court upholds Vermont ban on data mining

Wed, 29 Apr 2009 04:57:00 GMT

Pharmaceutical companies may soon be unable to collect prescriber data in Vermont.

District Judge J. Garvan Murtha cleared the way for the state to enact a ban on the data-mining of prescription drug information for marketing purpose when he ruled the 2007 law that bans the practice is constitutional.

PhRMA revises guidelines for clinical trials

Wed, 29 Apr 2009 04:55:00 GMT

Pharmaceutical companies should provide results summaries for all interventional clinical trials involving patients, according to revised industry guidance.

Companies should publish the summaries whether the FDA approves the medicines or the particular research programs have been discontinued

Smith & Nephew receives subpoena from DOJ

Mon, 27 Apr 2009 15:54:00 GMT

The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound stimulation product EXOGEN from 1995 and onward, the company announced.

EXOGEN is FDA approved for specific fresh fractures and long bone non-unions and was first marketed in 1998.

Smith & Nephew said it plans to comply fully with the request and believes its competitors have received similar subpoenas.

Third former device employee pleads guilty to misbranding

Mon, 27 Apr 2009 04:59:00 GMT

Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the Department of Justice.

As a territory manager for an unnamed medical device manufacturer based in Hopkinton, MA, Doyle promoted the devices designed to promote bone growth for unapproved uses, the DOJ said. Doyle promoted a combination of the devices with bone void filler, and in furtherance of that promotion provided mixing instructions to surgeons, medical technicians and others.

Doyle is the third former medical device employee to plead guilty to misbranding a medical device. Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device in February. In November 2008, Darnell Martin pleaded guilty to similar charge.

St. Jude warned about manufacturing problems

Mon, 27 Apr 2009 04:58:00 GMT

St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the Safire ablation catheter, the company disclosed in an SEC filing.

Physicians use ablation catheters to carefully burn heart tissue to disengage electrical signals that cause atrial fibrillation.

The FDA raised concerns about the facility after inspections conducted between December 8 and December 19, 2008, according to the filing. St. Jude detailed proposed corrective actions in a written response to the FDA.

The company believes it can resolve the problems cited in the letter and does not expect customer orders to be affected.

Biomet under investigation for possible fraud

Mon, 27 Apr 2009 04:56:00 GMT

Government investigators are examining allegations that Biomet improperly sold, promoted, and billed for its bone growth stimulation devices, the company disclosed in an April 14 SEC filing.

Federal authorities in West Virginia are investigating sales and marketing practices for Biomet’s subsidiary EBI, which makes electric stimulators for post-surgery patients. The U.S. Attorney in Massachusetts is also investigating possible improper conduct in the sale and leasing of the electrical-stimulation devices.

Quest to pay $302M for subsidiary's alleged misbranding

Mon, 27 Apr 2009 04:53:00 GMT

Quest Diagnostics and its subsidiary, Nichols Institute Diagnostics (NID) will pay $302 million to resolve civil and criminal allegations NID sold misbranded diagnostic tests, according to a Department of Justice (DOJ) release.

NID pleaded guilty to felony misbranding and will pay a criminal fine of $40 million. Quest entered into a deferred prosecution agreement. Quest and NID will also pay $262 million plus interest to resolve False Claims Act allegations relating five assays manufactured by NID that allegedly provided inaccurate results.

Read more about Quest’s resolution of the allegations.