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Examining drug issues in depth

This story was produced by Stat, a national publication from Boston Globe Media Partners that will launch online this fall with coverage of health, medicine, and life sciences. Learn more and sign up for exclusive content at Statnews.com.

Open your medicine chest and you’ll find bottles and vials that contain so much more than a needed remedy.

Each container actually holds a fascinating tale about the drawn-out process it took to develop the drug, the delicate dance required to win regulatory approval, the sometimes controversial steps taken to persuade doctors to prescribe the medicine, or the complicated calculus that was used to set pricing.

These are the sorts of issues that you will read about in Pharmalot, a weekly column that is debuting today as part of Stat, a national publication from Boston Globe Media that will launch online this fall and that will be dedicated to coverage of health and medicine news. This column will also continue to run in the Globe.


Let me introduce myself. I’ve run a blog known as Pharmalot for about eight years, most recently at The Wall Street Journal. During that time, I’ve tracked research and development; marketing wars; government oversight; the use of social media to reach patients; and pricing tussles with insurers, among other issues. The bio-pharmaceutical industry is, indeed, fascinating, but it can also be highly complicated.

So what I hope to do is help you identify and understand some of the biggest issues, many of which will ultimately affect your health as well as your pocketbook. Here are a few I’ll be following soon:

■  You can have sex or you can drink, but you can’t do both.

This crucial warning pertains to Addyi, the drug that was recently approved by the FDA to help women achieve sexual arousal.

A clinical study — largely conducted with men, believe it or not — found that mixing Addyi with alcohol can cause a precipitous drop in a person’s blood pressure and even fainting. Despite FDA rules designed to discourage women from drinking and popping an Addyi, some women’s groups and consumer advocates are concerned that some will do so, anyway. That, in turn, could prompt a backlash against the agency, which approved Addyi despite the drug’s somewhat limited ability to generate sexual arousal and despite concerns about interactions with other drugs.


■  Drug makers have free speech rights, too. Seriously, they do.

A few months ago, a small drug maker called Amarin filed a lawsuit arguing that its First Amendment rights would be violated if the FDA blocked it from distributing promotional material about unapproved uses of its drug. The agency has long argued that drug makers should be barred from actively promoting off-label uses, even though doctors routinely prescribe medicines for uses not approved by the FDA.

A federal court judge in the case reaffirmed Amarin’s argument, as long as material distributed to doctors is true and not misleading. The judge also suggested drug makers should first clear material with the FDA, to avoid legal trouble. Now, though, there are questions about the extent to which the FDA may pursue promotion of off-label uses.

■  My medicine costs how much? The rising costs of prescription drugs — they jumped 12 percent in the United States last year — is quickly becoming a problem for many Americans. Nearly one-quarter say they have difficulty affording their medicines, according to a recent poll. Meanwhile, government agencies and commercial insurers are scrambling to find ways to either limit usage of a steady stream of new, expensive medicines or somehow make room in their budgets.


Some doctors are also concerned. One high-profile group of oncologists launched a petition to ask Congress and the Obama administration to allow Medicare to negotiate drug prices and allow Americans to import cancer drugs. Still others are promoting formulas to assess value. What remains unclear is whether any of these efforts will compel drug makers to put a lid on prices.

■  Is the sky the limit . . . or is the sky falling?

Until the recent market plunge, most every biotech seemed to be worth, well, lots of money. Consider Axovant. The company, formed only recently, paid just $5 million to a big drug maker for an Alzheimer’s compound that in a study had only modest study results. Yet Axovant’s stock was worth $3 billion on the first day its shares traded publicly. The episode quickly prompted talk of a biotech bubble, and for good reason. But whether the big drop in stocks last week will truly temper such enthusiasm longer term is uncertain.

■  No, Virginia, we don’t yet have a cure for cancer, but . . .

This has been a historic year for therapies that harness the immune system to combat cancer. And several of the world’s largest drug makers are making strides testing treatments for different cancers. But the medicines are also raising intriguing questions. Will these treatments really succeed in combating different forms of cancer and, if so, how soon? Will high prices preclude access for some? And which drug maker may dominate the field?


■  You’re dying, but getting access to experimental medicine may be nearly impossible.

Patients and advocacy groups blame the FDA and drug makers for arbitrary and cumbersome procedures and are using social media and “right to try” state laws to speed the process. In fact, two dozen states now permit patients to approach companies that are testing experimental medicines. But critics say these laws are more about the right to beg than the right to try. Instead, Congress would probably have to adjust the process by passing new legislation. But how likely is that?

There are many other topics to explore. Meanwhile, feel free to send suggestions and story tips and follow me on Twitter. See you next week.

Ed Silverman can be reached at ed.silverman@statnews.com. Follow him on Twitter @Pharmalot. Follow Stat on Twitter @statnews.