How To Screw Up The Launch Of A New Drug

A treatment for Alzheimer's was botched
A treatment for Alzheimer’s was botched
Image Credit: Diverse Stock Photos

The one thing that every product manager would love to have would be a product that everyone needed. We could count on eventually selling it to everyone. Over at Biogen, their product managers thought that they just might have such a product. The life sciences company had developed what they thought might be a cure for the dreaded Alzheimer’s disease. There’s good chance that a lot of us may eventually get Alzheimer’s and so the market for this type of product could be huge. However, due to a series of missteps, they seem to have dropped the ball. What went wrong?

The Problem With A Blockbuster Drug

So let’s all agree on one thing: it can take a very long time to develop a new drug. Over at Biogen, they had been working on a new drug for Alzheimer’s disease for over a decade that seemed to have blockbuster potential. Their early results were so impressive that Biogen raced toward regulatory approval – a risky gamble. Outsiders anticipated sales of the first approved drug in nearly two decades to slow the advancement of a disease that affects up to six million Americans. Then the Biogen product managers changed their mind. The company made an unusual decision to abruptly stop its trials and declare that the drug didn’t work. The all of a sudden they reversed course and said the drug did work after all.

The U.S. Food and Drug Administration approved the drug under a program that fast-tracks promising treatments, despite disagreements within the agency over its efficacy. So where do we stand now? The result is there is a pricey therapy now on the market, Aduhelm, that regulators who approved it say isn’t fully proven to work against Alzheimer’s disease. The result of all of this is that many patients aren’t taking it because their doctors are reluctant to prescribe Aduhelm. Oh, and just to make things even more confusing, Medicare hasn’t decided if it will pay for the drug.

Biogen launched the new Aduhelm drug at a price of US$56,000 a year, only to backtrack and cut the price in half to quell backlash that had resulted over the price. In drug development, product management mistakes can be as much of a factor as the complicated scientific questions. With Aduhelm, it turns out that both played a role. The problem is that all these inconsistencies created one wave of criticism after another. Additionally, Biogen came up with a ridiculous price that added even more fuel to the fire. The FDA conducted a thorough review of Aduhelm’s data and concluded it warranted approval for patient use. However, they still held the company accountable for conducting an additional study to confirm that the drug works. If the study were to fail, the FDA could pull Aduhelm from the market.

How Did The Mistake Happen

So what happened during the development of this new drug? Biogen licensed the rights to Aduhelm back in 2007. They had high hopes despite failures of many rivals in tackling Alzheimer’s disease. The early trial results left Biogen officials so confident in their new drug’s success that they skipped doing the midstage trials, called Phase 2 trials, and proceeded directly to launching two Phase 3 trials – large clinical trials testing a drug’s safety and effectiveness that are typically needed to win FDA approval. Then, a hitch was discovered: when Biogen analyzed trial data reflecting patients’ cognitive conditions, it indicated the drug wasn’t likely to be proven effective.

By evaluating the data that has been collected midstream in approval-seeking trials, companies can try to predict whether a drug will succeed if they allow the trial to continue. Stopping trials early for “futility,” in industry terminology, can save a company millions of dollars and prevent patients from investing hope on what turns out to be an ineffective drug. Biogen executives who were on a small “senior decision team,” as the company called it, concluded that the trials were doomed. The result of this was that Biogen pulled the plug and asked researchers around the world to shut down their trials. At the same time they told more than 3,000 Alzheimer’s patients who had volunteered that they would no longer be receiving treatment.

Biogen product managers made errors in shutting down the trials. The trial plan called for analyzing their data after half of patients had completed the study treatment. By the time Biogen completed the analysis, three more months of additional data were available – but the team deciding to close down the trial didn’t scrutinize the additional data before the company halted the trials. Only in the weeks after the trials stopped did Biogen scientists complete a preliminary analysis of the additional data and recognize that they had made a mistake. The data seemed to show that one of the trials would have produced positive results, despite the likelihood of a negative outcome in the second trial. Biogen launched an effort to resurrect the drug with the FDA

Outside advisers at the FDA unanimously rejected the drug’s approval. Nearly every FDA council member voted against approval, just as the outside advisers had. Seven FDA leaders met to consider Aduhelm for accelerated approval, a fast-track program that lets the FDA clear some drugs for serious diseases before their medical benefits are fully proven. Five of the FDA officials supported approving the drug on the condition that Biogen do another trial. The head of the biostatistics office voted against approval of any kind, while a seventh official abstained. The FDA ended up approving Aduhelm. Only about 120 U.S. medical facilities have so far administered Aduhelm to patients out of the more than 900 sites that had been prepared to administer the drug when it was approved. Some hospitals have said they will not administer Aduhelm to their patients because of their uncertainty over the drug’s effectiveness and concerns about its potential side effects on patients.

What All Of This Means For You

New drugs can be expensive to create and take a long time to get approval to sell. Product managers who are responsible for these new drugs understand this and so they are careful to play by the rules that go along with creating new medications. However, over at Biogen, their product managers got caught up in a new drug that seemed to hold a great deal of promise. They ended up making mistakes and did a bad job of launching their new drug.

Biogen had been developing a new drug to combat Alzheimer’s disease for over a decade. They had started to see some real successes with this drug and the product managers started to get excited. They hurried up the field trial process and skipped to the final stage. During the final stage, the data seemed to indicate that the drug was not going to work. They halted the trials. However, when they took a closer look at the trial data, it seemed to indicate that the drug might work. The Biogen product managers went back to the FDA and restarted the approval process. Eventually the drug was conditionally approved by the FDA, but there is a great deal of doubt as to if it actually works or not.

The Biogen product managers made a fatal mistake when they tried to hurry up the drug’s approval process. They skipped a key step that could have provided them with more data about the drug’s effectiveness. Instead, they jumped to the final stage of testing which is much more expensive. They now have a partially approved drug that requires more testing. Hopefully, they’ll go back and do the required testing so that people will know if they can trust this new drug.

– Dr. Jim Anderson Blue Elephant Consulting –
Your Source For Real World Product Management Skills™

Question For You: What will the Biogen product managers have to do to get people to believe in their new drug?

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