its primary regulator. On one hand, the FDA’s rigorous review process ensures quality standards that put the pharmaceutical industry on a pedestal way above the snake-oil salesmen hawking nutraceuticals on late-night infomercials. The industry loves that, and when its companies are successful, they love how FDA regulation provides high barriers to entry for new competitors. But of course, the FDA sometimes bites companies in the butt, which they don’t like. If the pharma industry wants to appeal to the public, the same taxpaying public that the FDA is responsive to, then it needs to do something big to support this vital agency. I’m thinking of a pharma- and taxpayer-supported big data initiative that tracks adverse events in real-time. The FDA doesn’t have this kind of 21st century capability, which offers the promise of spotting rare, dangerous side effects before they become wide-scale drug safety catastrophes. Stossel told me he thinks this is a waste of time, because “the critics will trash it,” but I think it could be a real way to prove to the public that pharma is willing to put its money where its mouth is on safety. It’s also within our technological capabilities, and the right thing to do.
5. Don’t pay lip service to global health. Do something real. I’ve seen all the stories about CEOs of Big Pharma companies buddying up with Bill Gates at big summits devoted to coming up with vaccines and treatments for the world’s poorest people. Some of these efforts are well-intended, but others, if you scratch below the surface, are little more than PR exercises for the pharma companies. One of the bigger global health advances in recent years, a vaccine for meningitis in Africa, bears no Big Pharma fingerprints. And yet, people respond positively to stories like Merck’s development of mectizan, a cure for river blindness. If you spend $200 million coming up with a vaccine for malaria, and give it away for free, you could probably save millions of lives. It wouldn’t bankrupt any of the Big Pharma companies. And it just might generate 100 years of future customer goodwill in the developing countries where that kind of breakthrough occurred.
6. Discover more great drugs. Dazzle people. You can laugh at this one, because discovering drugs is easier said than done. But seriously, a redoubled industry effort on R&D at all levels, which delivers more great drugs, would be noticed. Create more drugs like Vertex’s ivacaftor (Kalydeco), Genentech’s trasztuzumab emtansine (Kadcyla) and Pharmacyclics’ and Johnson & Johnson’s ibrutinib (Imbruvica). People will always complain about price, but the pharma industry argument is far stronger when it’s defending life-changing therapies. Incremental innovation at a premium price is a losing business strategy in the long run. As they sometimes say in biotech venture capital, “Go big, or go home.”
7. Invest in your own employees. The biomedical industrial complex has educated lots of young graduate students and postdocs over the past decade, during the boom in NIH funding from the late-90s to the early 2000s. Many of these people are stuck with no job prospects, because they can’t get the precious few faculty gigs at cash-strapped universities, and most haven’t gotten all the training and mentoring they need to be relevant for jobs in industry. Ethan Perlstein, a former Princeton University postdoc who struck out recently on his own as an independent scientist, has referred to this phenomenon as the “postdocalypse.” This is a huge recruiting opportunity for pharma, to snap up lots of bright people at entry and mid-levels and train them for long careers in industry. Instead, you just see wave after wave of layoffs in R&D, as companies seem to be almost throwing in the towel on all their good medicinal chemists, molecular biologists, biochemists, and more. It’s short-sighted, and unfair to those people. This isn’t a poverty-stricken industry like my former world of newspapers, which can’t afford to hire people. Pharma can and should do this for its long-term survival.
8. Stop breaking the law in your sales and marketing departments. “Off-label” marketing has got to stop. If you want to market a drug for a new population of patients, spend the money and do the hard work of proving it works. Industry insider John LaMattina, a former president of R&D at Pfizer, said so himself in a January column on Forbes.com.
9. Invest more in the basic public R&D system. Put your own money into more sponsored research at academic institutions, which are starving because of NIH budget cuts. Be the white knight for basic research into understanding of genomics and cell biology, which will lead in all kinds of fascinating directions. And don’t stop there. Use your political clout in Washington, DC, to go to bat for the NIH, for real. The public knows that you fight tooth and nail for your patent rights, and for your Medicare Part D drug benefit—things that benefit your industry’s narrow self-interest. Pharma spent more money on lobbying than any other industry in 2012, although it dialled back spending earlier this year, according to the Center for Responsive Politics. How about putting some money to work aligning pharma with basic biomedical research, a broader public interest, that also happens to benefit the industry? How about playing hardball politics on behalf of the public? I wonder what would happen if Big Pharma called on its friends in Congress, and vowed to withdraw campaign contributions from people like Sen. Ted Cruz until they restore NIH funding to pre-sequester levels. What would elected officials do if this powerful lobby used its resources to run TV ads that shame them, in their home states, for pulling the rug out from under our nation’s great biomedical research centers? A majority of the public would cheer.
10. Stop direct-to-consumer TV advertising. These ads make the industry look like a bunch of hucksters, not all that different from juicer-masters or whatever of late-night TV. It cheapens the value of these drugs, making important advances like AbbVie’s adalimumab (Humira) look like bar soap or breakfast cereal. It’s all white noise to consumers after a while. If you want to be seen as a science-based industry genuinely interested in human health, then make your best arguments on data to doctors and patients, not emotional or demographic identity-based appeals. The 30 or 60-second spot is for entertainment, not medical information. You’re probably wasting your money, so why not stop? TV ratings aren’t what they used to be anyway.
11. Work more on enabling technologies, and find creative ways to fix the clinical trial process. “The industry must figure out how to fail faster,” said Shaywitz. That partly means working with regulators on new study designs. But it also depends on the industry’s own ability to find technological ways—bioinformatics, stem cell models, organs-on-a-chip, whatever—that will reduce the time, expense, and risk of clinical trials. The randomized, prospective, double-blind, placebo-controlled clinical trial is still the gold standard for determining whether a new drug or vaccine works, but that may not always be the case. The technology industry used to have high costs to entry as well, during the dot-com era, when every Internet company had to spend millions of dollars on infrastructure, like servers. Now you can build an Internet startup quickly, on a shoestring budget, while renting cloud server space from Amazon. It’s made it much easier for people to start companies, try things, fail, see what works, and iterate fast to get some traction. Pharma and biotech still don’t have an enabling technology quite like cloud computing, and it needs to invest in that kind of thing if it wants to do better.
12. Come up with a moonshot. It was beyond most people’s imaginations in the 1960s when John F. Kennedy set a goal of putting a man on the moon before the end of the decade and bringing him home safely. It was a classic “big hairy audacious goal” or BHAG, as they say in the business schools. These can be incredibly motivating, inspiring things for people in the industry, and can captivate the imagination of the public too. What is pharma’s moonshot today? A cure for Alzheimer’s by 2025? Or is it Calico, the Google-backed startup led by former Genentech CEO Art Levinson, which aspires to extend human lifespan by decades? I don’t know what it is, or should be, but I have to believe that some success on a pharmaceutical or biotech BHAG would be enough to earn the respect of most people, even in our cynical world.
That’s it for my suggestions this week. Am I totally full of beans? Got any better ideas? Please share. Leave a comment in the section below, drop me a note at [email protected], or fire away on Twitter @ldtimmerman
