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This Drug Didn’t Work for Me. May I Have My $88,000 Back, Please?

If you bought a new toaster, carried it home, plugged it in, and it didn’t work, what would you do? Suppose you purchased a pineapple at the grocery store, sliced it open, and found it was inedible. In both cases you’d seek the same remedy: you’d return the item and ask for your money back. With reputable merchants, the chances are extremely high that you would receive both an apology and your refund. If the merchant wouldn’t return your money, you could likely get the charges reversed anyway if you paid by credit card.

Now let’s look at one more variation on this theme. Imagine that you bought (or had someone buy for you) a product that cost a whopping $88,000. You used it according to the manufacturer’s directions, but not only did this product fail to work, it significantly raised your blood pressure or caused a hemorrhage. You’d want to get your money back for sure. But in this final scenario, you are a breast cancer patient, and the thing you (or more likely your insurance company, or Medicare) paid all that money for is a cancer drug called bevacizumab (Avastin). Genentech, the medicine’s manufacturer, follows a general convention in the industry and offers no refunds if this drug doesn’t work. My question is: why not? Wouldn’t it make sense for manufacturers to refund the cost of uber-expensive drugs that provide no demonstrable benefit to a majority of patients?

The use of Avastin in breast cancer patients has been mired in controversy. The FDA created an “accelerated approval” program in 1992 to speed the arrival of critical drugs onto the market for those with life-threatening diseases, like AIDS or cancer. Avastin, Genentech’s best selling drug, won FDA approval in 2004 for treating metastatic colon cancer and in 2006 for non-small cell lung. It received conditional approval in 2008 for use in breast cancer patients, even though it failed to extend their survival in a clinical trial. The preliminary approval was given with the concomitant requirement that there be a later review to see if the drug conferred either a survival benefit or improved quality of life for patients. The subsequent analysis showed that in this particular disease indication bevacizumab provided neither benefit, and its approval for use in breast cancer patients was rescinded in December 2010. Genentech appealed the decision, but a just completed review by an FDA advisory panel led to the same conclusion. The panel voted unanimously that breast cancer patients should no longer use the drug.

This decision does not prevent doctors from still prescribing the drug “off label” for their breast cancer patients. However, it reduces the likelihood that your insurance company will pay for the drug to near zero, meaning that you will have to pay for it out of pocket. This medicine is not cheap, with doses for the typical breast cancer patient costing $88,000 a year. The practical result is that only the wealthiest patients will be able to afford this (and other) expensive medication for “off-label” treatments.

A recent Wall Street Journal editorial opined that it was bad medicine for the FDA to rescind the drug’s approval for breast cancer patients. This was based on the fact that while bevacizumab demonstrated no overall statistical survival benefits to breast cancer patients, anecdotal reports suggest that a small (but unknown) percentage of patients responded favorably to the drug. I can readily sympathize with patients who may feel that a potential lifeline is being taken away from them. However, the advocacy group Breast Cancer Action agreed with the FDA decision to withdraw the treatment’s approval for this specific disease indication. As their Executive Director, Karuna Jaggar, succinctly stated, “…anecdotes are not science….”. Christine Brunswick of the National Breast Cancer Coalition echoed these comments “The FDA’s decision on Avastin must be based on scientific evidence from well-done trials and cannot be based on any one individual story, no matter how compelling.” The FDA itself was unable to find any evidence for the existence of a population of “super-responders” to the drug.

The problem with the WSJ argument, of course, is that it could just as easily be applied to nearly all drugs. It’s possible (maybe even likely) that you could find a tiny fraction of patients tucked away in the tail end of the bell-shaped curve that might somehow benefit from any rejected medicine if you looked … Next Page »

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The Author

Stewart Lyman is Owner and Manager of Lyman BioPharma Consulting LLC in Seattle. He provides strategic advice to clients on their research programs, collaboration management issues, as well as preclinical data reviews.

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  • steve

    I can envision several benefits to such a proposal and at least one unintended benefit

    – greater job opportunities for unemployed and underemployed attorneys. Going after drug companies for reimbursement plus punitive and pain and suffering damages might be quite lucrative.

  • Simo

    If you bought a pineapple and it turned out you were allergic, would you expect the grocery store to refund your money? If it cost $88k, maybe you would. But the real problem is that the drug costs that much even though it costs only a few dollars to manufacture. Which gets back to the way our government grants patent monopolies, how we fund pharmaceutical research, and how we provide health care to our citizens.

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  • Orla

    This is a ridiculous suggestion. Pharma companies are already forced to cut their spending on discovery research, by shareholder demands by the way, not by the people working there. They stop making money, they go out of business; end of story. You think generic drug comapnies develop new drugs? No, because the failure rate of potential therapeutics is astronomical; only a fraction of a percentage even make it to clinical trials. Should we stop looking for these needles in haystacks that do work? Of course not. But it costs money to look and the consumer has to pay for that search, not just the manufacturing costs of the sucessful drugs.

  • http://www.lymanbiopharma.com Stewart Lyman

    Thanks to Steve, Simo, and Orla for taking the time to comment. Yes, some drugs are very expensive, but the foundations of our drug discovery and pricing system are too large a topic to cover in a short op-ed piece. My focus here was to propose a possible solution for how some very expensive drugs might be paid for by insurance companies if the firms selling them are willing to put their money where their mouths are and assume some of the risk. While Medicare and Medicaid have announced that they will continue to pay for Avastin even if the FDA removes its approval for breast cancer patients, an unknown number of insurance companies are likely to stop paying for what will then be an unapproved use. While Orla thought my suggestion wass ridiculous, Janssen-Cilag adopted it. They must have thought that the money-back proposal put forth by NICE was worth their while, or they never would have accepted it. Let’s set aside for the moment the general issue of astronomical prices of cancer medicines, many of which are going to need to be given in combination to be more-than-just-a-little-bit effective. Medicine is just on the verge of beginning to identify patients who may benefit from a drug, and segregate them from patients who won’t benefit. For most drugs, however, this type of personalized medicine approach is still down the road. Are there other suggestions out there for making expensive drugs available to patients wishing to try them when they aren’t covered by insurance? How do you affordably get new medicines out to a potentially small subset of patients who may benefit from them before the technology exists to identify these patients up-front?

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  • http://www.linkedin.com/profile/view?id=57527&trk=tab_pro Marc Samet

    You have such a valid point that NICE…the National Institute for Clinical Excellence…the UK equivalent of the FDA…has approved reimburesment for some cancer drugs ONLY if they do something in extending the life of patients receiving the medications….if nothing happens then the UK system won’t pay for the drug and/or will demand a refund….RIGHT ON!!!!