Wednesday, December 16, 2009

Pushing drugs to doctors and patients

Another day has gone by without the CBO producing a "score" of the revised bill. Until it does, the Senate is unable to proceed on scheduling the first of several procedural votes needed to get the bill passed before Christmas. But, I did find a fascinating CBO report on promotional spending on prescription drugs. The CBO director's blog summarizes the highlights. Among the key findings: in 2008, spending on detailing to physicians was by far the biggest outlay of funds ($12 billion); followed in order by direct-to-consumer advertising ($4.7 billion); sponsorships of meetings and events ($3.4 billion); and advertisements in professional journals ($0.4 billion). Total promotional expenditures, "equaled 10.8 percent of the U.S. sales reported by the Pharmaceutical Research and Manufacturers of America, in line with most years since the early 1990s, during which time that share has remained between 10 percent and 12 percent."

Also of interest, according to the full report:

* The growth of pharmaceutical manufacturers' overall promotional spending has slowed from a double-digit annual pace in 2003 and 2004 to a rate that is close to zero. That slowdown is probably related, at least in part, to the decline in the number of new drugs that have received FDA approval since 2000.
* In the second half of the 1990s, the FDA approved an unusually large number of drugs, some of which were the first on the market to treat certain conditions and a number of which treat widespread conditions. Not only are fewer new drugs being approved of late, but more drugs also face competition from generic versions. Those factors may be particularly important in explaining declining spending on DTC advertising, which peaked at $5.2 billion in 2006, because pharmaceutical manufacturers tend to use more DTC advertising for drugs that have especially broad potential markets, drugs with few or no substitutes, or drugs with some combination of those characteristics.
* Of the more than 2,000 drugs included in CBO's data set, 700 to 800 have some promotional spending reported in any given year. For nearly all of those drugs, some spending on detailing was recorded. However, manufacturers purchased DTC advertisements for fewer than 100 of those drugs in each of the years since 1995, the year the data set begins to encompass DTC advertising, making DTC advertising the least frequently used form of drug promotion . . . . Journal ads and professional meetings are used to promote fewer drugs than detailing but more drugs than DTC advertising.

As someone who watches a lot of sports broadcasts -- and with them, way too may ads for ED -- I was frankly surprised that DTC is "the least frequently used form of drug promotion." Most of the money is still being spent the way it always has: to influence physicians and clinicians to prescribe a particular drug product.

The CBO reports a relationship between promotion to physicians and advertising to consumers: "When pharmaceutical manufacturers promoted drugs to consumers, they also spent more, on average, promoting those drugs to physicians. For those drugs in CBO's data set with reported spending on DTC advertising, their manufacturers spent an average of $40.5 million per drug in 2008 on promotional activities directed to physicians -- 14 times the average amount they spent when promoting drugs exclusively to physicians That difference may indicate that manufacturers use promotional activities directed to physicians and DTC advertising to reinforce each other."

The relationship between money spent to persuade consumers to ask for new drugs, and for doctors to prescribe them, will continue to be scrutinized by policymakers. (For relevant ACP policy, see our policy paper on direct-to-consumer advertising and our ethics resources about physician industry relations.) The CBO report makes an important contribution in increasing understanding of how and why the dollars flow where they do.

Today's questions. Why do you think drug companies still spend most of the money on promoting their products directly to physicians? What are your own policies on engaging with drug company sales persons?


Robert J. Sobel, M.D. said...

The pushing of drugs goes beyond just what you have mentioned. The intertwining of the medical literature with the drug development process and the courting of thought leaders makes it hard to figure out who is leading whom. Clearly, though, the process works. GERD and PPI's. Atypical antipsychotics and use in depression and bipolar.

While we restrict our interactions, I have kept limited access to drug reps, as the sample process remains a method for bypassing the extreme costs of brand drugs. Is it a conflict of interest? I really don't think so. Is it a ridiculous process that could be eliminated if the brand-generic market were reformed? You bet.

The overt dichotomy between brand and generic has driven the marketing machine and its coordination to unprecedented heights. The effort put into marginal additions in our armamentarium is a direct result of the Hatch-Waxman Act. When brands had staying power, the process was not so supercharged. It puts us in a very unfortunate position where, by definition, the use of a new drug is guaranteed to be cost-ineffective.

In addition to cost considerations, which are only getting worse as patients bear a larger and larger portion, the loss of autonomy and the ceding of control to third parties is the most dangerous phenomenon.

Take ARB's. As Cozaar goes off patent now, the machinery will attack millions of doctor-patient relationships in the name of cost saving. Does this machinery really offset its costs? Does anyone measure the inherent risks (dosing confusion, unexpected drug interactions, continuity of therapy interruption)? Do the financial incentives at the level of pharmacies and pharmacy-benefit companies further erode credibility?

Where is the justice in the uneven playing field and the temporal control given to the drug life cycle realities? Without a coherent strategy to control drug costs, our health insurance system is exploding, in both the public and private sectors. We should much more urgently address this issue. Importation was not the answer. Further coercion toward generics isn't either. A brand only environment where Regulated Royalties is introduced remains the only way I see that we can maintain our prescribing autonomy.

The time is now. The ARB fiasco will follow the Zocor/Lipitor fiasco. This is what affects doctors and patients every day. This is where Congress should act. Go to any primary care office and see for yourself what kind of chaos reigns at the fax machine. It is outright abuse. It should be outlawed.

Steve Lucas said...

Doctors need to understand that you are the drug company’s customer. Patients, such as myself, may be drivers, but we do not write the prescriptions. Another reality is that in selling one doctor you get many prescriptions, in selling one patient you get one.

One problem pharma has had of late is that doctors are not speaking to drug reps. To this end we see in the 12/15/2009 WSJ article Pfizer Adds new Type of Tablet to Sales Calls the addition of a tablet computer by Pfizer that require the doctors signature to receive samples.

The stated reason is to comply with federal regulations. The business reason is the doctor must actually speak with the rep. I am also sure there is a tickler system that will prompt the rep that when listing a drugs to sell a related product.

Pharma also relies on doctors to continually support the contention that only branded drugs are of sufficient quality to be used in this country. Often I have been told by doctors that generics are junk, knowing that the same company is producing the same drug in the same facility.

I have also been told that with my income and insurance I should support the drug industry by not only insisting on branded drugs, but in “taking advantage” of all of the “benefits” of taking a large number of prescription medications.

Peer-review is not a guarantee of a factual presentation of a drug’s performance. Many in academic medicine move back and forth or have ties to industry. Doctors need to realize that on their first day of medical school, along with all of their other roles, they become sales managers. They need to be skeptical of everything they are told by not only drug reps, but in some instances, by teaching staff with ties to industry.

Steve Lucas

Rich Neubauer MD said...

This is an interesting diversion from the Health Care Reform theme, but in many ways not really a diversion at all. The most expensive piece of medical equipment that physicians wield is the pen. When we write a prescription, order an imaging study or invasive test or refer a patient to another provider we are directly influencing the overall cost of care. That this is an area ripe for improvement in “bending the cost curve” needs to be acknowledged.

Entanglement between physicians and the pharmaceutical and medical device companies is pervasive and a bit nefarious. As you point out, ethical guidelines, professional society policy papers and many articles in the medical literature have explored this topic and tried to sensitize the physician community about this issue. The fact that industry spends the most dollars on detailing simply means that it works for them.

The other side of this coin of course is that without the drugs and devices provided by industry we would not be delivering the miracle of modern care to patients.

Personally, over the years, I have spoken with pharmaceutical sales representatives on a limited basis. As former director of a CME program, the emphasis of such meetings has been on soliciting displays at meetings within ACCME guidelines. I’ve arranged such meetings with representatives with the understanding that I do not want to be “detailed” (although occasionally they would “sneak one in”).

Overall, I’ve been pleased to see the trend toward increased scrutiny of the relationship between industry and physicians. As we move toward further discussions of bending the cost curve, this is an area that demands continued thoughtful attention.

Jay Larson MD said...

My favorite advertising quote: "Advertising can best be described as the science of arresting human intellegence long enough to get money for them" Stephen Leacock (1869-1944) humorist and political economist.

From the time of medical school to decades of practice, the superiority of Branded drugs have been branded into our brains. This misconception continues to be reinforced by the pharma sales reps.

Pharma sales reps know that if a physician just can think of their drug the first time when a prescription is needed, the refills will keep the pharma profits up. By having do-dads and samples around, brand name recognition can increase the odds of that medication being prescribed.

As Steve points out, docs are only the ones that can prescribe medications. (Though insurance companies don't realize that when they hammer docs with prior auth requests).

About 2 years ago, I went through our office and threw out every thing with a drug name. I tossed out a giant sack of pens and garbage bag full of other do-dads.

We do not talk to sales reps, If they need to talk to us to leavesamples, they just don't get to leave samples. Like Robert, I often will give samples to patients with limited incomes and there is no generic alternative.