It’s been 927 days (back of our envelope, anyways) since Senators Charles Grassley and Herb Kohl first introduced the Physician Payments Sunshine Act, a bill that would require drug and device companies to disclose on a public, searchable website the gifts and payments they make to physicians and teaching hospitals. (Postscript is younger by a few weeks.)

Today, the Sunshine Act became law, as a provision in the national health care reform bill signed by President Obama. You can read the final provisions here.

Though it has not captured headlines like the coverage provisions and insurance regulations in the reform bill have, today’s passage of the Sunshine act is itself a dramatic answer to years of growing questions about how to balance the need for industry to work with academic researchers and the need to keep patients safe with good prescribing that is free from the influence of marketing. In recent years, that line has often proved a blurry one, as a series of investigations and media reports revealed that physicians have received millions of undisclosed dollars in speaking and advisory roles for drug companies, even as they conducted research on drugs made by those companies. PostScript has been along for much of that ride (as the archives in the right rail attest).

The momentum for Sunshine has come from a lot of corners – the investigations and hearings, led by Sens. Kohl and Grassley, that brought to light some of the most dramatic conflicts-of-interest between marketing and medicine.

It has come from many Members of Congress, who co-sponsored, worked on and advocated for Sunshine over the years.

It has come from academic medical centers and professional medical associations, who took a look at their own relationships with industry and developed policies to clarify those relationships.

It has come from the AMSA Scorecard, a joint project of the American Medical Student Association, Community Catalyst and the Pew Prescription Project  to rank the conflict-of-interest policies at every medical school in the nation.

It has come from state lawmakers and regulators, who brought bills and rules aimed to better safeguard prescribing from the influence of marketing dollars.

It has come from the efforts of numerous groups, including ours here at Community Catalyst and at the Pew Prescription Project.

It has come from the broad-based National Coalition for Appropriate Prescribing, which helped remind Congress why transparency is so important for consumers.

And it has come from pharmaceutical and medical device companies, many of whom acknowledged, in revised conduct codes and voluntary disclosure measures, that gifts don’t have a place in the doctor’s office.

We are proud of this collective effort, and all the work that went into getting Sunshine on the books. Thank you.

–Kate Petersen, PostScript blogger

PostScript goes to the Hill this week, where the Senate Aging Committee held a hearing on academic detailing, the practice of providing doctors with unbiased, evidence-based drug information to counteract pharmaceutical sales pitches.  The hearing was held in anticipation of legislation from Sens. Herb Kohl (D-W) and Richard Durbin (D-IL) to build a federal academic detailing program.

According to the BNA Health Care Daily Report, “The Kohl-Durbin proposed academic detailing legislation would provide grant money to public entities…for hiring academic detailers who would provide educational materials at doctors’ offices and conferences.”

Among those who testified were Dr. Jerry Avorn, a Harvard Medical School professor and lead of the Independent Drug Information Service in Pennsylvania; Sharam Ahari, a former drug-rep who now educates about insider tactics of sales reps; and Allan Coukell, policy director of the Prescription Project.

The BNA also reported that a Senate committee aide called the bill a cost-saver and anticipated strong bi-partisan support.  Read the Prescription Project report on the cost-effectiveness of academic detailing here.

More coverage in the Wall Street Journal Health Blog, ABC News, and Medical News Today.

Good day, Sunshine

And yesterday on the other side of the Hill, Reps. Peter DeFazio (D-OR) and and Pete Stark (D-CA) announced a companion bill to the Senate’s Physician Payments Sunshine Act.  Both bills would require drug and medical device companies to disclose payments to physicians twice yearly in a centralized and public online database.

The Prescription Project is a member of the National Coalition on Medicine and Marketing, which supports both bills. Read DeFazio and Stark’s news release here.

Data-mining bill falls in Evergreen State

The Washington state legislature came close to passing a data-mining bill that would have prevented the commercial use of prescriber data in that state, but fell a few votes short at the close of session.  To find out more on what happened, check out Kate Petersen’s interview with state Rep. Jamie Pedersen at the NLARx website.

Firms settle in drug-pricing case

And news of a third settlement in a 2002 drug-pricing class action lawsuit came this week.  Plaintiffs were awarded $125 million in the case, which alleged that drugmakers artificial inflated the Average Wholesale Price, used by many public and private payors to set drug prices.  Read all about it at the PAL blog.

PostScript saw this in the Wall Street Journal Health Blog, and maybe you did too: A new study published in the Journal of General Internal Medicine says that nearly half of physicians surveyed have given a patient a placebo.  According to the Healthblog, calming the patient was among the most popular reasons that a physician had prescribed a placebo, though 6 percent of docs checked yes in the “to get the patient to stop complaining” category. 

On one hand, this is So What stuff. The word placebo comes from the Latin placare, to please or calm.  So the reasons docs cited for using placebos line up with the purpose of the faux therapies to the letter.

On the other hand, it raises eyebrows. When we talk about doctors tuning out the pharma detailers, we talk about wanting them instead to rely on evidence-based prescribing, but is there something deeper we need to account for? If, as this study suggests, a statistically significant number of prescriptions are being written to calm a patient or get a patient to stop complaining, that adds another variable (where PS stands for patient satisfaction) to the already complex prescribing picture of Americans’ trip to the pharmacy.  To us, it seems such considerations have a piling on effect to pill-requests spurred by direct-to-consumer ads and the lunch-bearing supply-side pressures coming from pharmaceutical sales reps.

First, it’s important to acknowledge a couple of things: the JGIM survey was a small sample size – 466 internists at Chicago-area med schools – and only half of those MDs canvassed replied.  Recall bias, science-speak for the fallibility of the human memory, may be at play. Moreover, numerous studies have shown placebos to be effective in treating clinical ailments, an effect that is often attributed to the “mind-body connection,” and the brain’s significant role in how we are sick and how we are made well.

Still, as the Healthblog points out, the practice of prescribing placebos – whether it be a straight sugar-pill, an antibiotic for something a doctor suspects is viral, or a drug for an indication that drug has not been approved for (off-label) – brings up some sticky ethical questions.  Off-label prescribing is appropriate in many cases, and inappropriate and dangerous in many others. Antibiotics have been so overprescribed that the CDC set up a task force in the late 90s which is working to prevent anti-microbial resistance.  Wal-mart and other mega-pharmacies began to sell $4 generics last year, effectively removing another barrier to prescribing a medicine that may not be needed, but sure won’t hurt.  If a patient feels better, then gets better, is prescribing something he or she thought was something else unethical, or merely medicine by different means?

Let’s face it: doctors are practicing in a Hot-or-Not world – a world where they are being rated by patients like restaurants a la Zagat on trust, communication, availability and office environment, and where managed care has privileged formularies over behavioral health treatment, and placed time constraints on office visits, especially for primary care physicians. 

To lower cholesterol, a doctor may write a script for a simvastatin for a patient who has been uncooperative to dietary changes or exercise, even if the doctor believes lifestyle adjustments, adhered to, would do the trick.  And by prescribing an antibiotic for a most-certainly viral malady, doctors protect themselves from the slim chance of leaving a lethal case of bacterial pneumonia untreated.  The lines between the unnecessary, the supplemental, and the just-in-case are thin and in places all but unreadable.

Taken alone, this survey is a coin in the fountain of issues around the ethics and practice of health care in this country.  But it does break the surface, and send a ripple of questions through practitioners’ and patients’ minds: if some of us get better by thinking we are being treated, does that justify the use of placebos? And if it does, then what are the rules for using them? Certainly patients ongoing work to win an audible consumer voice has improved health care dramatically, but how far does the patient-as–consumer model take us before the practice of scientific medicine takes a hit?

And with so many participants, consumers, and profiters in the prescribing picture, how much wiggle room is there to move physicians toward evidence-based prescribing?