Opinion

The Great Debate

Don’t demonize drug samples. They are crucial to our healthcare

By Guest Contributor
September 8, 2010

AIDS DEATH RISE DESPITE CALLS FOR TREATMENTThe following is a guest post by Grace-Marie Turner, founder and president of the Galen Institute, a non-profit research organization focusing on patient-centered solutions to health reform.

Medical researchers recently confirmed a link between chronic fatigue syndrome and a recently discovered retrovirus. Armed with this knowledge, some doctors are now prescribing HIV drugs to their sickest patients.

This story highlights how difficult it is for physicians to find the right medicines for their patients. The interaction between a particular drug and the human body is incredibly complex. People react to the exact same treatment in very different ways.

As a result, doctors often rely on samples that the pharmaceutical companies give them so they can determine more quickly if a particular drug is right for that patient. That is good and timely medicine. And every drug the companies give away has gone through years of testing with the Food and Drug Administration to make sure it is safe.

Yet under the new healthcare overhaul law, pharmaceutical firms are required to provide Congress with detailed reports on all of the free drug samples they provide to physicians. Some lawmakers see this requirement as a step toward an outright ban on free samples, making it more difficult for doctors to customize drug treatments for their patients.

But samples serve a crucial clinical role. They allow doctors to learn more about the drug to see how well it works. Also, patients are more likely to start treatment if they walk out the door of their doctor’s office with the medicine they need.

Across the country doctors have testified that samples help them improve patient care. Anand Mehendal, a neurologist in Kerrville, Texas, recently said that he uses samples “to see whether the patient is going to tolerate the drug.” Similarly, the American Medical Association has stated that “samples of prescription drug products represent valuable benefits to the patients.”

Severely restricting pharmaceutical samples would dramatically increase the cost of care. In fact, these samples actually save our health system money in the long run. Doctors use them as a way to test treatments before asking patients (and/or their insurers) to pay for a full supply.

Drugs samples are also a valuable supplement to the drug industry’s efforts to give low-income patients access to needed medications. Most pharmaceutical companies run charity programs that provide drugs at little or no cost. Doctors often help people who are struggling financially by giving them samples. In 2007 alone, Pfizer, Merck, Eli Lilly, Baxter, and Abbott Labs gave out 240 million drug samples valued at just about $3 billion.

Drug samples are not only valuable, but also are valued by both the patient and the doctor. A 2006 poll published in the Journal of Medical Ethics found that 90 percent of physicians and pharmacists consider the practice ethical. And a 1995 survey in the Journal of the American Board of Family Practice found that 90 percent of patients believe it’s okay for their doctor to accept samples from drug makers.

So if drug samples are popular with physicians and patients, why are lawmakers demonizing them in this new health law?

Critics charge that samples are nothing more than a marketing gimmick to get patients to purchase more drugs. They also say the reporting requirement will provide transparency and prevent drug makers from unduly influencing doctors.

But doctors have sworn an oath to do what’s best for their patients. It’s ridiculous to think that doctors’ ethical principles could be bought off for a few free drug samples.

Lawmakers shouldn’t demonize this practice.

Comments
4 comments so far | RSS Comments RSS

Many good points have been made in this article. It should be noted however, that no clinical trials to judge the safety or efficacy of HIV drugs in CFS patients have been done at this time.

This doesn’t mean there won’t be pilot studies done in the coming months or that a retrovirus is or is not the cause or one of the causes of this severe neuroimmune disease. Pilot studies have already shown that some anti-virals have been effective in some subsets of patients with different viruses.

Only that until further data is collected in a clinical study, some scientists are urging caution. Immune modulators might however be appropriate.

Posted by klatta | Report as abusive
 

Is it too much to ask of the Pharmaceutical Companies to actually track these “free” drugs? What happens if there is a re-call and no one really knows who has received these drugs? Do the physicians who use these “free samples” document in the patient record that these samples were used?

While look-back studies are a real PIA, this should not deter anyone who may have received these free samples to if they took the drug.

For example: a physician in Kerrville, TX gives a patient a free sample and the patient has an adverse reaction to it, then logic would say that the physician would find a different medication to treat the disease. Does the physician report the adverse reaction, as the medication was free? What if the medication is later found to affect most patient’s in the same manner as his patient, does the patient remember anything about the medication, except that it was free and didn’t work.

So before saying that Govt is just out to control an industry, blah blah blah, one might consider that they are actually working to be able to track drugs for the good of the patient.

And yes, I work in a FDA regulated industry, it is a PIA, but if the record keeping isn’t mandated, then no one will actually do it. And that has detrimental consequences, so whine and then look past how much “extra work” it may cause and start considering this from the patient’s perspective.

How many individuals may die as a result of the paperwork being just “too much”?

Posted by afisher | Report as abusive
 

The Prescription Drug Marketing Act (PDMA) of 1987 was put into place to ensure pharma companies track all prescription drug samples distributed to licensed practitioners. This Act was meant to prevent fraud, contamination and the selling of samples in the black market – so all pharma companies operating under the Code of Federal Regulations is already tracking sample distribution down to the licensed pracitioner level & sometimes lot level. Mandatory reconciliaitons are also enforced by the FDA as a means to control and track samples distributed. The fines and penalties for non compliance are huge and can include jail time.

So, after a pharma company ensures request and receipt of the drugs, it is then left up to the practitioner to track these samples down to the patient level (so this is where the gap lies), as a pharma company cannot track down to a patient level. There are some states that mandate physician sample tracking, however not all states make this tracking mandatory.

If a licensed pracitioner is not willing to track a sample down to the patient level to document potential adverse events, then that office should be banned from receiving samples – but to place manufacturers and pharma companies at blame for “enticing” sales by distributing these samples, it is not right and the needy will miss out.

It would be extremely hard for authorities to enforce this type of tracking at the physician level because the FDA is already overwhelmed with other monitoring activities – so if this tracking was enforced, it would take a low priority and because of this, the physicians office will not take it seriously.

I mean come on….did the banning of pens, clocks and pads (which costs pennies to make) distributed by drug reps to physicians really help any practitioner to prescribe one drug over another? If it did…..that physician should not have been in business to begin with. This banning act alone costs the manufacturers of these type “trinkets” their jobs – once again contributing to the already dying economy.

This along with the downsizing of pharma companies, the new Sunshine Act & states like Vermont requesting extreme and unheard of information, and the laying off of thousands of sales representatives leaves me wondering where do we go from here? What’s left and how can new therapies (meant to benefit the patient) be distributed to physicians if every where a pharma company turns, is greeted by a brick wall.

In my opinion, the potential banning of samples will force physicians to prescribe drugs to patients that may not work. It will take longer to discover what works and what does not work — it will also cost the patient more out of pocket costs because full prescriptions will have to be brought. A sample is just that, a sample. Obviously meant to promote the sale of anything. Food or drugs. For example: Go into Sam’s Club — taste it, like it, you buy it. If you don’t like what you’ve tasted, keep walking, no harm, no foul.

Posted by DJay | Report as abusive
 

As a public mental health social worker for my locality I completely agree with this. The unintended consequences of reporting these samples is huge. Look at it this way- many uninsured and under insured patients we see cannot afford their prescriptions so we give them samples. Now the monetary value of these samples are being listed as a “gift” to the prescribing doctor. As a result many doctors are refusing to give them out in fear of tarnishing their good name. As a further result those patients who relied on samples must now either pay high out of pocket costs, switch to a cheaper and less effective medication, or go without. In the mental health world when a patient goes without that often means they end up in the hospital or even worse- the correctional system. So please people, calm down about samples- in the long run they keep costs way down for everyone.

Posted by slwker | Report as abusive
 

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