Why Don't Pharmaceutical Companies Give Refunds?

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It is typically standard practice for a business to offer a refund if a product proves to be defective to the point that it is useless.

So why can't we return a bottle of useless pills to the pharmacy and get our money back? I'm not suggesting that the pharmacy recklessly resell the pills to another customer; rather, they should return them to the manufacturer, which in turn should destroy them.

A Solution for Unused Pills

One example of over-prescribed pills is antidepressants, specifically the class known as selective serotonin reuptake inhibitors (SSRIs). This class includes Prozac, Paxil, Lexapro, Zoloft and others.

Doctors have been writing millions of prescriptions each year for these drugs. Sometimes, because of side effects, serious adverse events, or simply because they don't work, patients are left holding a good portion of the pills. So their doctor tries another one. Maybe a third.

In every instance of failure, and especially when one considers the active campaign to mislead the public through direct-to-consumer advertising, consumers are stuck with a bottle of useless pills. They're told what not to do with them – "Don't give them to anyone else" or "Don't flush them down the toilet" or "Don't sell them." Instead, patients should have the option to return the pills to the pharmacy to be destroyed.

It is absurd on its face. You might argue that under the current health care system, refunds would be too complicated. I would respond that this is not the consumer's problem; that's not something with which the consumer is obligated to be concerned. When you return a dysfunctional drill to The Home Depot under a standard return policy, is the onus on you to worry about the logistics of The Home Depot sending the drill back to the manufacturer? Do you care, or do you just want the working drill that you're entitled to because that's what you were sold?

The question underscores a much bigger issue.

The Pfizer Lawsuit

Several months ago, a consumer fraud class action lawsuit was filed in U.S. District Court in San Jose, Calif., against pharmaceutical giant Pfizer. The plaintiffs' claim? That Pfizer's product, the SSRI Zoloft (sertraline hydrochloride), did not do what Pfizer claimed it would do – treat their ailments.

And these patients wanted their money back.

Because not only did the drug fail to relieve their depression, but – and here's the rub – Pfizer has known for a long time that Zoloft is no better than a sugar pill and that it causes adverse events in patients. Despite this, the company aggressively and illegally marketed Zoloft as an effective treatment to the tune of $30 billion in revenue.

Specifically, the lawsuit accuses Pfizer of knowing that Zoloft's "efficacy in treating depression was, at best, marginal and at worst, nonexistent." The lawsuit claims that despite knowing it had a dud on its hands, Pfizer withheld negative trial data, submitted manipulated trial data to peer-reviewed medical journals through ghostwriters, then paid prominent members of the health care community to pump up Zoloft as a great breakthrough in depression treatment.

Patients suing drug companies because their products caused them physical harm is common.

Government prosecutors suing them for bilking the likes of Medicare or for illegal off-label marketing is common too.

But patients suing a drug company because its product was ineffective is likely precedent-setting. The issue illuminates a common practice among pharmaceutical companies that has hurt or killed thousands of unwitting people.

The Fate of Unimpressive Trial Data

Consumers and clinical trial participants have long assumed that if a drug company carries out a clinical trial – whether privately or by using some government funds – that the raw data from that trial will be made available to FDA regulators, regardless of outcome.

This could not be further from the truth. In fact, pharmaceutical companies have been burying negative trial data for decades, with impunity. The companies routinely run Phase III trials more than once, because often all they need is for the data to show that their product is better than a placebo.

A company is not required to show that its product is an improvement on existing treatments, but that it's better than nothing at all. This is why we see effective drugs copied by other pharmaceutical companies ("me too" drugs). We go from having no treatment on the market for a certain ailment to having a handful in a very short time, like we have seen in SSRIs and in the treatment of chronic myeloid leukemia.

When Irving Kirsch and colleagues published a meta-analysis of the data submitted to the U.S. Food and Drug Administration by Big Pharma for antidepressant approval, their findings were conclusive: Antidepressants barely outperformed placebos, and only then in severely depressed patients. Infuriated clinicians and representatives of the pharmaceutical industry fired back as best they could, but so far the findings have been irrefutable. Kirsch also revealed regulatory agencies as being pushovers for Big Pharma.

Furthermore, as revealed by The Milwaukee Journal Sentinel and MedPage Today, for more than a decade Big Pharma reps have been paying tens of thousands of dollars in fees in order to sit in on invitation-only conferences with FDA and NIH officials, indicating that there is a sort of pay-to-play relationship going on between regulatory officials and the companies they are supposed to be regulating.

This cozy relationship encourages the swiftness by which "me too" drugs are developed, and it invites danger. After all, it takes many, many years to know for certain whether or not a drug actually works as intended, at least in the case of drugs that are designed to treat illnesses in which there are no biomarkers, such as depression and anxiety. Yet before that can be established, "me too" drugs spring up with regulatory approval, looking to cash in on the success of the original blockbuster drug.

Public Health Menaces

Earlier this year, Dr. David Healy wrote a scathing essay on the original SSRI, Prozac, as the drug commemorates 25 years as a public health menace:

Twenty-five years ago, no one could have imagined that the bulk of the treatment literature [for Prozac] would be ghostwritten, that negative trials could be portrayed as glowingly positive studies of a drug, that controlled trials could have been transformed into a gold-standard method to hide adverse events, or that dead bodies could have been hidden from medical academics so easily. Twenty-five years ago no one would have believed that a drug less effective for nerves or melancholia than heroin, alcohol or older and cheaper antidepressants could have been brought on the market and that almost as a matter of national policy people would be encouraged to take it for life.

AllTrials logo

There is now a huge movement underway to force drug companies to put all data from all clinical trials in the public domain since it so directly affects the public health. The largest and most important of these is All Trials Registered | All Trials Reported, spearheaded by physician and author Dr. Ben Goldacre, and supported by the BMJ and the James Lind Initiative, among others.

When drug companies bury important data on drugs, they deliberately mislead your physician into believing in the efficacy of a treatment, which he or she then passes on to you.

On top of that, people who participate in clinical trials do an incredible service for us all by doing so. But if trials don't end favorably for them, drug companies are perfectly willing to forget they ever happened, forget the participation of patients in need of help, and in many cases forget the serious adverse events discovered in that trial – like a heightened risk of suicide ideation, for example.

As consumers, we have a right to demand our money back on these products. Otherwise, we are denied any basic financial semblance of caveat emptor and we are subjected to the substandard products of an industry in bed with federal regulators, leaving little hope that we can rely on the medical community to offer the level of care for which it is known and for which we pay so much.

 
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