PhRMA Prefers No "Second-Guessing Motives" When Discussing Pharmaceutical Sampling

Yesterday, a joint study conducted by Harvard Medical School and Cambridge Health Alliance was released in the American Journal of Public Health addressing the demographics of those patients most likely to receive pharmaceutical drug samples.

The study will be published in February 2008, but you can read the abstract here - "Characteristics of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis."

Not surprisingly, the big pharma lobbying group, Pharmaceutical Research and Manufacturers Association (PhRMA), was not pleased with the conclusions of the study and released a statement in response. However, you may notice that the link is no longer good, because the statement was revised and re-released today here.

I wonder how many people actually had an opportunity to read the original? I did. My comments are emphasized below.

PhRMA Defends Distribution of Pharmaceutical Samples;
New Study Fatally Flawed, 2003 Figures Outdated

Washington, D.C. (January 3, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement regarding the Jan. 2 American Journal of Public Health study on distribution of free pharmaceutical samples:

“Distribution of free samples by technically-trained pharmaceutical research company representatives – many of whom are healthcare professionals themselves – plays a critical role in improving patient care and fostering the appropriate use of medicines. Providing physicians with free samples of pharmaceuticals clearly benefits patients and advances healthcare throughout the United States.

So free samples improve patient care? Those research company reps who provide physicians with free samples serve to advance healthcare (ie. provides a way to extend the post-marketing review of new name-brand medicines.)

“Instead of second-guessing motives, Harvard researchers would better serve patients by examining health outcomes. Clearly, free samples often lead to improved quality of life for millions of Americans, regardless of their income.

Is that free samples which improve quality of life? I thought that PhRMA's mantra was that drug research and miracle medicines improve the quality of life for millions of Americans.

“Free pharmaceutical samples can give physicians valuable first-hand experience with new treatment options. And free samples can help patients begin treatment sooner, find the right medicine, and offer an option for those who have difficulty affording their medicines.

Notice how the term 'free' has been used six times already?

“As the study authors note, when patients were seen by practitioners in their offices, uninsured patients ‘appear more likely to receive a free sample than do insured persons.’

“According to the study authors, this suggests that office-based
practitioners make a ‘sincere effort’ to use free samples to help needy patients.

“Likewise, insured patients who lacked prescription drug coverage also were more likely to receive a free sample.

So PhRMA wants to remind the reader that 'free' (3 more times) samples are used to address the lack of prescription coverage for some patients and the neediness of others.

“Indeed, a recent Henry J. Kaiser Family Foundation survey found that 75 percent of physicians frequently or sometimes give free samples to assist patients with their out-of-pocket costs. An earlier survey examining key factors influencing physicians’ decisions to distribute free samples found the ‘patient’s financial situation’ was a considerable or strong influence 86 percent of the time.

'free' 2x more

"That said, the study released Jan. 2, which was conducted by Harvard Medical School and Cambridge Health Alliance researchers, was fatally flawed.

Here it comes... the official PhRMA mantra... the Partnership for Prescription Assistance is here to help. I've discussed PPArx before here, here, and here.

“The study, which relies on 2003 data, ignores significant outreach efforts in recent years, including the 2005 launch of the Partnership for Prescription Assistance (PPA), a program sponsored by America’s pharmaceutical research companies to help uninsured and underinsured patients.

“Our member companies recognize that, unfortunately, many uninsured and underinsured patients do not receive their medical care from office-based practitioners.

So does that mean that lack of medical care from office-based practitioners is to blame for the failings of pharmaceutical samples as an effective safety-net for uninsured and underinsured patients?

“And, as important as free pharmaceutical samples are in improving healthcare, they represent one – not the only – option for patients in need.

“As a consequence, over and above the billions of dollars in free samples that pharmaceutical research companies distribute to physicians, our companies have provided medicines worth more than $10 billion, in wholesale value, to nearly 5 million struggling Americans since PPA was launched.

“Additionally, we have hand-delivered information about accessing free or nearly free medicines to clinics and hospitals nationwide that serve low-income Americans. And we have connected more than 200,000 patients with clinics and healthcare providers in their communities.

'free' 4x more

“PPA is a clearinghouse for more than 475 public and private patient assistance programs. More than 2,500 brand-name and generic prescription medicines are available through the participating programs.

Please note that some of the participating programs are simply discount cards which may, or may not, give the holder as little as 0% off the retail price of their medication.

Patients who need help should call...where trained operators field calls in more than 150 languages...

Too bad the trained operator I spoke with last summer could not speak English.

Here's part of PhRMA's press release which was edited out:

"The most troubling facet of the study is that it relies on data from 2003 to present a picture that could be markedly out-of-date, relative to what is occurring during physician visits today.

“In addition, the samples distributed during the study period tended to be pharmaceuticals to treat chronic conditions. Thus, it is predictable – not surprising ­­– that there would be a strong linkage between patients’ age and receiving free pharmaceutical samples. Patient age strongly correlates to such medical conditions as arthritis, and uncontrolled cholesterol and blood pressure levels.

"The pharmaceutical samples that were distributed to those patients were new to the market and, at that time, were perceived by physicians to offer benefits to patients with uncontrolled disease.

So what's the big deal with that omission you ask?

Drug samples raise patient safety concerns, according to author Dr. Sarah Cutrona, a physician at Cambridge Health Alliance and an Instructor of Medicine at Harvard. (via Cambridge)

"The distribution of free samples has become very controversial. Evidence shows that free samples may influence physicians' prescribing behavior and cause safety problems. For instance, we found that the most widely distributed sample in 2002 was Vioxx, with Celebrex being number 3. These drugs turned out to have lethal side effects. While many doctors still view samples as a safety net for their neediest patients, our study shows that samples are potentially dangerous, and do little for the needy."

I guess PhRMA didn't really want to bring attention to the fact that some newly-approved, most-promising, blockbuster medications may have undiscovered lethal side-effects.

The Cambridge/Harvard study is the first to look at free drug samples nationally and found that most free drug samples go to wealthy and insured patients and are not used to ease the burden of the poorest nor the uninsured.

Dr. David Himmelstein, senior author of the study, a physician at Cambridge Health Alliance and an Associate Professor of Medicine at Harvard adds: (via Cambridge)

"We know that many doctors try to get free samples to needy patients when those patients come into the office. We found that such efforts do not counter society-wide factors that determine access to care and selectively direct free samples to the affluent. Our findings strongly suggest that free drug samples serve as a marketing tool, not as a safety net."

And if there is any doubt about that, just look to the controversy surrounding the proposed licensing of drug reps in Washington, D.C. and other jurisdictions in the country. It is widely accepted that drug reps are basically salespeople who go office-to-office to try to get physicians to prescribe more of their brand-name drug.

Please keep in mind that...

"Free drug samples are not the solution to the disproportionately low amount of health care resources going to the poor and uninsured; they are part of the problem," said Dr. Steffie Woolhandler, a physician at Cambridge Health Alliance, Associate Professor of Medicine at Harvard, and study co-author.

(h/t WSJ Health Blog "Poor Get Short Shrift on Drug Samples.")