Remember when Merck was the most admired company in America? When pharmaceutical companies ranked among the most respected of all industries, because of their achievements for human health and well-being?
I don’t. I was born in 1975, putting me smack in Generation X. I started paying attention to the business of biomedical innovation, as a journalist, about a dozen years ago. My experience, like others my age and younger, is shaped by an endless series of headlines that portray the pharmaceutical industry as the bad guy. The public belief in the U.S. is that drug companies are the ones who price-gouge Grandma and Grandpa. They hide their dirty laundry—like dangerous side effects on top-selling products. They talk a good game about science and innovation, but they have failed to deliver big health advances for most people over the past couple decades. They have a reputation for unseemly wining and dining of influential doctors. Most people would probably put pharma’s reputation on par with Big Tobacco.
But it hasn’t always been this way. I was struck recently by an experience reading a 20-year-old business book, called “Built to Last,” written in less cynical times. The authors, like many business writers in the ‘90s, wrote about Merck with awe. They quoted, without any snark, George Merck’s motto about how if the company served patients, the profits would naturally follow. This idea created a powerful science-based culture that gave the company a competitive edge.
It’s stunning to witness pharma’s fall from grace. I tend to believe the wounds are largely self-inflicted, as pharma lost its moral compass and put profits ahead of patients. But I also believe that science is a fundamentally good force for progress, and that pharma has made many great achievements building on its investment, and society’s investments, in basic biomedical science. There are many supersmart, dedicated, well-meaning pharmaceutical and biotech employees today who are getting results. If they didn’t have adequate economic incentives, we’d never get them to work so hard creating the great drugs, vaccines, diagnostics, and devices that do a lot of good. There’s no reason why pharma should always be destined to be a public enemy.
Given pharma’s current reputation, it shouldn’t surprise anyone that the industry has endured years of adversarial, rather than more constructive, regulation at the FDA. The thicket of burdensome conflict-of-interest rules that have been enacted at universities and research institutes, which impede collaboration with industry, were put there because of a desire to prevent more confidence-shaking scandals. Patients in the U.S. are slow to enroll in clinical trials, slowing down the innovation process. Morale inside many of the pharma companies is poor.
So what are some actions pharma can take to turn this around, to rebuild some of the public trust it once enjoyed? I tried to put together a list of ideas this past week. I spoke with David Shaywitz, a thoughtful industry commentator for Forbes who works as a strategist for a San Francisco-based biotech company, and Thomas Stossel, the director of the translational medicine division at Brigham & Women’s Hospital in Boston. Stossel, a forceful defender of pharmaceutical companies and frequent writer on the subject of academic/industry relations, dismissed almost every remedy I suggested to repair pharma’s public trust.
What the industry really needs to do is “fight back” harder against its critics, Stossel said. Many of the big pharma scandals of the past decade, like Vioxx and Avandia, were overblown by the critics and sensationalists in the media, he says.
“The bad reputation didn’t come from bad things the pharmaceutical industry did. It came from lies,” he said.
Stossel makes some persuasive points about how the “pharmascold” movement has gone too far, cutting down on academic/industry collaboration, undermining continuing medical education, and creating unnecessary barriers to medical progress. But, respectfully, I don’t think the industry is a blameless victim, and I don’t think the industry will dig itself out of a hole by attacking its critics. An industry PR offensive isn’t enough to restore public trust.
So, in the spirit of stirring constructive dialogue, here are 12 suggestions—some that others have advocated for years, others that get less notice—that I’d like to put forward for consideration.
1. Stop overreaching on drug prices. Yes, I know, you have to move mountains to develop a new drug, when you add up all the time, money, and risk that goes into the equation. Pricing is based more on what the market, dysfunctional as it is, will bear—not the cost of manufacturing or development. The market should reward real innovators with high prices, when they offer a great benefit to patients. But even when the market allows for a high price, how much is too much? Time and again, I’ve seen companies over the past couple years push drug prices to stratospheric levels that surprise and sometimes shock Wall Street analysts. Some of these drugs are important advances. Others are more incremental. Even the co-pays on these drugs are so high that they can bankrupt middle-class people with so-so insurance. If the industry wants to continue to command such high prices in the U.S., in an era of healthcare cost containment, it absolutely must start proving—once and for all—that its drugs are cost-effective, not just effective enough to win FDA approval. That means if you want to charge $100,000 for a drug, you had better be able to prove that you save the healthcare system even more money by reducing hospitalizations, disease complications, and improved quality of life/work productivity for the affected patients. Healthcare reform is making cost-effectiveness essential anyway, so it only makes sense to get on board.
2. Support greater data transparency. Share data widely, even the bad stuff. There’s been a transparency movement going on for a while now, as industry critics in academia are seeking highly granular data from clinical trials to evaluate drug safety and effectiveness. This is the kind of granular data that regulators at the FDA and EMA get to see, but is typically off-limits to all others. A few companies have taken steps in the direction of greater data transparency and data sharing, but it’s mostly lip service at this point. I know the pharma industry fears that it would be giving away a gold mine of data to its competitors, putting patient privacy at risk, and a treasure trove of details for tort lawyers trying to play gotcha games. These are issues that need to be worked out, and shouldn’t be excuses for inaction. It’s time to get on board with transparency, because it would build more trust, and it’s how the world works in the Internet age. Wide-scale data sharing is also one of the best ideas out there for helping the industry break out of its R&D funk.
3. Get real about patient engagement. Shaywitz suggested this one. It’s about “really trying to understand and solve the patient’s problem, not just selling them more pills,” he says. “we need to be less transactional and more relationship-focused.” This is partly a culture thing. Genzyme, for instance, was famous years ago within the industry for its dedication to helping patients with Gaucher’s disease, a rare and debilitating condition. Selling them the company’s lead product was part of it, but Genzyme sought to take a more holistic view of the patient, to really listen to what their issues were, and try hard to solve them. Pharma would be wise to dust off the old Atul Gawande article in The New Yorker to see what patient engagement looks like in the treatment of cystic fibrosis. In the future, drugs will be part of the solution, along with integrated digital health offerings that help keep track of whether patients are staying on their meds or suffering any unusual effects. If people felt like the pharma companies truly cared about solving their problem, that would be a great way to replenish the goodwill reservoir.
4. Support the FDA, even when it might hurt. The industry has a love/hate relationship with … Next Page »
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