Envisioning 2.0

I will be taking a break from blogging until the first week of June.

Those interested in reading some of my content during this period can head over to HealthCareVox.  I’ve set up my blogging software to post a series of popular posts on social media, the biotech industry and other topics.

I’d like to take this time to thank all those who read, comment and share content posted on this blog each week.  Your ongoing support and readership is appreciated.

I’ll see you in June

Today’s New York Times features an interesting article focusing on how the anti-abortion movement is starting to gain ground due, in part, to a change in communications strategy.  In past decades, abortion foes have focused on the fetus rather than the woman having the procedure.  Today, according to the Times, pro-life advocates are focusing on how abortion may impact women.  Specifically, they argue that an abortion negatively affects a woman’s physical and mental health.

This argument is gaining ground legally.  In a recent Supreme Court decision upholding a ban on partial birth abortions, Justice Anthony Kennedy said: “While we find no reliable data to measure the phenomenon, it seems unexceptionable to conclude some women come to regret their choice to abort the infant life they once created and sustained . . . Severe depression and loss of esteem can follow.”

Anti-abortion strategists consider their fight to reframe the abortion debate as similar to the effort to define smoking as harmful.  According to the Times: “Allan E. Parker Jr., president of the Justice Foundation, a conservative group based in Texas, compares the campaign intended for women to the long struggle to inform Americans about the risks of smoking. ‘We’re kind of in the early stages of tobacco litigation,’ Mr. Parker said.”

Right now, it appears that the pro-life movement’s strategy of re-framing the abortion debate is becoming increasingly effective.  To date, abortion proponents have not yet come up with an effective counter-strategy.

Last week, Purdue Pharma pled guilty to “misbranding” the powerful painkiller OxyContin. According to the Wall Street Journal, company executives admitted that they misled the public about the drug’s addictive qualities.

The settlement not only damages Purdue’s reputation, but Big Pharma’s as a whole, as news of yet another scandal saturates the Internet, newspapers and the airwaves. Sidney Wolfe of public citizen said that it will take a “PR miracle for executives at Purdue to regain trust in their consumers due to their deceitful efforts . . .”

Sally Satel, resident scholar at the American Enterprise Institute, has a different opinion. In an editorial published in yesterday’s Wall Street Journal, she asserted that the “real public health damage” of the OxyContin scandal “comes from the pitched campaign conducted by zealous prosecutors and public-interest advocates to demonize the drug itself.” Later in the editorial she said: “Was the penalty for Purdue Frederick out of line? I don’t know. But the price for those already in pain promises to be steep. Pharmaceutical development of improved slow-acting opiate medications may be derailed by fresh paranoia . . . This newest injection of malignant hype is the last thing they need.”

What world is Satel living in? I agree with David Williams, author of the Health Business Blog who said: “Purdue has a duty to promote the drug appropriately to keep it available for those who need it. But Purdue stepped over the line in promotion and in doing so may inadvertently make it harder for people with serious pain to get access to powerful meds.”

Purdue admitted that company leadership, including the CEO, contributed to the problem. Will pain sufferers be cautious about taking a highly addictive medication? They should be. With this settlement we can finally be sure that consumers will receive the appropriate warnings and guidance on how to benefit from OxyContin.

Novartis has been touting its new rennin inhibitor Aliskiren as a new breakthrough in high blood pressure treatment, but some prominent physicians disagree. Drs. John Laragh and Jean E. Sealey conducted an analysis of six Aliskiren clinical trials and concluded that the drug is no better at lowering blood pressure than older treatments. However, some researchers are questioning their analysis because is partly based on the measurement of plasma rennin levels. Renin, an enzyme produced by the kidneys, helps to regulate blood pressure.

Laragh and Sealey concluded that: “aliskiren in combination with a diuretic appeared to lower blood pressure more than an aliskiren-angiotensin receptor blocker combination, but still failed to control blood pressure (<140/90) in 50% of . . . patients.” In addition, they assert that “while Aliskiren suppresses from 90% to 95% of plasma renin activity . . . it also causes significantly larger reactive rises in plasma renin concentrations than [other high blood pressure] drugs . . . an effect that cancels out its blood-pressure lowering effects.”

Dr. Matthew Weir, who helped to test Aliskiren in clinical trials disagreed with Laragh and Sealey’s assessment, saying:

“The claim that renin inhibitors are equally effective as other blood pressure drugs is true . . . [however] [t]hey’re creating hypotheses about how drugs affect the renin-angiotensin system, and in particular they’re referring to renin levels, which no one measures.”

Laragh & Sealey Tout Generics; Some Docs Sit On Fence

Laragh and Sealey conducted this analysis in part in order to make the case that older, cheaper blood pressure medications are just as effective as newer products. They say that diuretics (water pills) and other medications are safer and when “properly targeted” are “broadly effective.”

Other physicians are taking a wait and see attitude toward Aliskerin. Dr. Bob Centor, who writes DB’s Med Rants said that he normally waits a year before using any new medication. While “this class may [or may not] represent a major benefit,” he said. “We need to follow the literature and learn about this drug over time.

This week an interesting article by Robert Langreth was published in Forbes focusing on how Novartis has avoided some of the problems plaguing other drug firms by consistently pumping out new medications.  In an industry filled with dry pipelines, Novartis has introduced 15 new drugs in the past decade.  Its closest competitor in the R&D derby is Merck, which has had nine approved by the Food and Drug Administration.

Daniel Vasella, Novartis’ CEO has long bemoaned the quest for short-term financial results.  He’s been putting his money where his mouth is by diversifying the company’s portfolio and focusing on rare diseases.  According to Forbes:

“Rare diseases were long relegated to the backwaters of the drug business, targeted by tiny biotech companies, if at all, and often ignored by drug giants in their search for billion-dollar franchises. But Novartis is in pitched pursuit of some of the more obscure maladies in the world.”

Novartis is following in the footsteps of biotech firms like Genzyme, which have reaped large profits by developing treatments for uncommon conditions.  By focusing on the “long tail” of illnesses, Vasella hopes to protect the company from the ups and downs of the drug development business.  He said:

“One of the problems in the drug industry is that people believe they can manage the pipeline financially. . . If you look too early at the dollar signs, you get it wrong.”

So far, Novartis’ gamble appears to be paying off.

Last week Jim Edwards of BrandWeek reported on the lackluster sales of NitroMed�s flagship medication, BiDil. This drug, developed for “self-identified” African American patients with heart failure, has been a disappointment. Last quarter it only racked up $3.2 million in sales.

BiDil received a great deal of publicity when it was launched because it was the first drug approved by the FDA for the treatment of a specific racial group. Edwards suggests that BiDil’s woes cast “doubts on race-based medicine.” He argues this is because blacks may not be as black (genetically) as many may think.

John Mack, who writes Pharma Marketing Blog, disagrees. He blames NitroMed’s failed marketing campaign for BiDil’s woes. He says that the real problem with BiDil sales may “have more to do with inadequate or ineffective marketing than with less-black-than-you-think genes. It is notoriously difficult to market to minorities and I don’t believe the pharmaceutical industry knows how to do it well or invests enough time or effort figuring out how to do it. You don’t see, for example, very many industry conferences devoted to the subject.”

I know at least one person who would agree. In an interview I conducted with noted researcher Dr. George Bakris, who has done a lot of work with minority populations, Bakris gave the pharmaceutical industry a D on its communications efforts. He believes “drug firms spend more time educating on the product rather than the disease.”

While their arguments about the failure of BiDil are compelling, neither Edwards or Mack are correct. BiDil failed because it is simply a new formulation of two generic medications with a tedious dosing schedule. Dr. Keith Ferdinand, who helped to study BiDil, had this to say when I asked him whether marketing was to blame for BiDil’s poor performance:

“I do not believe that the slow uptake of BiDil (isosorbide dinitrate/hydralazine HCl) can be attributed to weak or inappropriate marketing. Perhaps clinicians were reluctant to use a branded medication when generics are available. Another barrier may have been the fact that patients must take the medication three times per day when they already have complex medical regimens.”

There you have it. Despite compelling clinical evidence and pressure from the NAACP, NitroMed has not been able to sell BiDil because it is hard to convince physicians (and insurers) to use a medication that has an equally effective generic counterpart. The company is currently developing an extended release, once daily formulation of BiDil. It remains to be seen whether the drug will be approved or successful.

Rather than focusing on race or marketing, BiDil’s failure can be traced to economics 101. It’s all about price.

at InsureBlog.

Update: I spoke with John Mack, who produces a podcast on pharmaceutical marketing, this week about Lilly’s disclosure of its grantmaking activities.  Click here to listen to it.

Yesterday, Eli Lilly and Company became the first drug firm to begin online posting of all “educational grant funding and other monetary contributions provided to US-based organizations.” According to Lilly, it posted this information to strengthen “the standards the company had established to assure ethical grant making. The registry will increase accountability and hopefully lead to greater public trust.”

Lilly’s move comes at an opportune time as government officials begin to closely scrutinize pharmaceutical industry funding of non-profit organizations and patient groups. In addition, as I announced last week, an Envision Solutions study indicates that many Americans are deeply skeptical of drug firms’ motives for funding medical societies and other organizations.

The new registry is a welcome sign. But, will other pharmaceutical companies follow suit? Are non-profit organizations prepared to become more transparent?

Lilly notes on its Website that it “will assume [its] industry peers will hear about our actions via the news media and other sources. While we cannot speculate, we hope their reactions are positive.” I hope so too.

To learn more about Lilly’s registry, please click here.
Information about Envision Solutions’ study can be found here.