Sunday, August 29, 2010

FDA Warning Letters: The 30,000 Foot View

In 2008, the FDA issued 21 warning letters for what it considered misleading marketing tactics. So far this year, the agency has issued 68 – Baxter International Inc. received one in early September. A week after the FDA said that the drug maker made misleading claims about the efficacy of its lung drug, Aralast, Baxter withdrew the offending material.

We think it’s time to take the 30,000 foot view on the FDA’s aggressive game plan.

Are industry members behaving so badly that the agency has had no choice but to triple the number of warnings? We think that’s unlikely. What is more likely is that the FDA is reacting to political pressure to rein in industry members. While in some cases there is arguably a need for such pressure, we have to ask: Are patients getting good information from all this regulation, and is it even valuable?

From our vantage point, the FDA's promotional review processes are over-regulating marketing materials, and all these warning letters show that. One unintended consequence of the agency’s overzealousness -- as well as some industry attorneys' -- is that the public thinks that industry products are unsafe. Now our interpretation of the FDA's guidance is to warn and make people aware of the risks, but should the risks outweigh the benefits a new therapy can have?

Could all this "regulated information" being put out by companies be creating more harm than benefit?  More patients are looking for product information on the Internet. What happens when they end up on sites where the information is less than accurate?

While we suggest that industry members follow FDA regs to the letter so they can avoid embarrassing mentions in the media, we also would love to see the agency explain how its mandates are contributing to the public’s health. Is the end product of a FDA promotional review really well received by the public?

Thursday, August 26, 2010

EHRs are real, but business execs may not think so

No surprises here: More than 100 IT-healthcare managers and execs, in a recent survey conducted by Embarcadero Technologies, said what worried them most about running an electronic health records system were database performance; integration of different data; and data quality. But these same executives said they are also ready for it.  

Right now, about 6% of doctors in the U.S. have Electronic Health Records (EHRs), and even fewer hospitals have them; but that’s expected to change once the new HITECH (Health Information Technology for Economic and Clinical Health) stimulus money kicks in. So why are we talking about this type of IT topic?

Because it also mentions that with more than $19 billion dollars available as part of the HITECH act, it is no surprise that close to 60% of respondents were in the process of implementing an EHR system. The HITECH Act also establishes 25 major “Meaningful Use” (MU) requirements that all electronic medical records systems must implement in order to have their users qualify for billions in government incentive money. 

So if these guys say they are ready and the dollars are behind it, why is the adoption of EHRs going so slowly?  When will we reach the tipping point? Our thought, IT professionals do not drive the business, the business people do, and they are not driving adoption of this type of "record keeping" because it is messy and complicated.  Oh, by the way, they do not have to interact with these systems to get the information they need to do their jobs, so they do not support its implementation as much as they should.  

The survey also asked these IT professionals to rank their level of agreement with areas related to “meaningful use.” Half strongly agreed or agreed that the existing information on MU and Certification and suggested their level of knowledge and technical competence was adequate to implement these systems. 

Again, this work has the potential to fundamentally change the way medicine in this country is practiced. The IT know-how is there, the money to get it started is there, so why is it not being adopted more quickly?  John Kenneth Galbraith once said, "When people are faced with change or proving why they should not change, they get busy with the proof."  We cannot help but think, all stakeholders involved with this change are kicking and screaming with their reasons to not change.  

Of course, that doesn’t mean everyone will buy the same equipment. The survey found the respondents were contracting with many vendors. Perhaps it would make sense for industry to think about vendor collaboration. Better yet, let's make all the business folks enter their healthcare data into an EHR, work with its output for several months, and then we believe adoption will grow.  

Industry will gain a good deal from the secondary use of electronic health records. Whether the information is captured at the patient level and used to help in the research and development programs or the data are gathered during a clinical trial, EHRs can help all parts of medicine, as Deloitte points out.

Monday, August 23, 2010

Data Mining in the Real World

Once upon a time, the business of data mining did not exist -- drug reps gathered such data on their own. Predicting sales was less than scientific. But, as the business of data mining grew, the science of predicting sales became more accurate, and industry loved it.

Today, not everyone feels the love. Three states -- New Hampshire, Maine and Vermont -- all have some type of ban on data mining. Critics of data mining say that letting industry have this information interferes with the doctor-patient relationship and more money is spent on expensive medicines. They also argue that data mining violates a physicians’ privacy – an issue these folks need to take up with the AMA, we think.

We argue that data mining serves an excellent purpose – and that is to see how drugs are being prescribed in the real world. Drug A was expected to bring in this much revenue,  but it's brought in that much. Why? Does it have an unknown side effect? Drug B was approved for this purpose, but it seems doctors are prescribing it for another purpose. Does it warrant a study?

Eliminating data mining will have unintended consequences for the general public. While it will eliminate the privacy concerns -- something the critics want -- it will limit health care data to only those government health officials with access to Medicare and Medicaid prescription data. These patients represent only a portion of the population, and a skewed portion at that.
Still, we see this glass as half full.  Eliminating data mining may force drug reps to return to their roots, something that seems to be happening to pharma companies in other areas as well. Then, the focus was not so much on who to call on, but on supplying information of value to the provider. Flying blind might have been scary for some, but for many of us older reps, we found it worked because we developed relationships built on trust and credibility.

Isn't that why qualified, experienced reps are hired in the first place? 

Thursday, August 19, 2010

The Free Sample Debate

A blog post on KevinMD about how free drug samples raise health care costs garnered lots of responses. What we found interesting was the diversity in the responses – some extremely anti-pharma, some very pro-pharma, some were in the middle and saying let’s be practical about this.

The author’s essential argument, often opined before: Once the patient is finished taking the free samples, he will get a script for the drug, instead of a generic version, thus raising the cost of health care. But is it really?

One of the practical responders used Lipitor as an example. A patient’s LDL is 160, and the physician wants it under 100. While the generic simvastatin is effective, the patient would need the highest dose of 80mg to reach the goal – but the higher the dose, the higher the odds that side effects will occur. Simvastatin has no samples, and costs $10 per month at the local pharmacy. The physician prescribes Lipitor. Why? He can reach the goal at the 20mg dose. Even though it costs $25 per month, the physician has a free 4-week drug supply to ensure there are no side effects, plus coupons that can stretch for a year. By then, Lipitor should be generic. “Using the branded product with samples and coupons [I] just saved you $120 for the year, allowed you to try the med first, and gave you a drug that worked better with fewer side effects,” he wrote.

This scenario shows how important free samples can be. What have we learned from this? That some doctors don’t know their drugs, even the well known ones. That drug samples have a place in the world, because a physician could show what Lipitor at 20mg v simvastatin 80mg could do. What concerns us is that not one of the dissenters in the "ban the sample debate" chooses to share their stories like this one.

No one denies that free samples are a successful marketing tool. But denying that free samples can often help the right person, at the right time is short-sighted. Industry critics need to keep in mind the unintended consquences of their intentions.

Monday, August 16, 2010

Separating Industry and KOLs – How It’s Really Playing Out

We have been watching with keen interest the reaction of those people who want all dealings between industry and the medical community squelched, and their reaction to how separating industry and physicians is really playing out.

It's not happening quickly. In our recent blog post, we cited a study in which most physicians surveyed had no problem with an industry paid-for lunch. And in this blog, we discussed how quickly the ACCME changed its mind about allowing some types of industry-sponsored content at CME events after some major KOLs said, "Wait a minute, is this really necessary?"

Maybe people who want to keep industry and physician advisers at arms' length thought it would be easy to undo decades of collaborative effort. That a few editorials, some subcommittee hearings, a few influential reports, and some accusations would do the trick. While it is impacting these business practices, our concern continues to be the lack of focus these pundits have on understanding the unintended consequences.

Industry and the medical community have been collaborating for decades. This merger of bench and the clinic has been often helpful, and profitable. There is no evidence to suggest that this collaboration cannot continue now: The remarkable collaboration that just took place among Alzheimer's researchers is proof-positive.

We are not arguing against transparency. We are arguing against branding physicians as guilty until proven innocent.

Wednesday, August 11, 2010

Prescription Drug Web Sites: A Few Wrong Rubs

A study that looked at the Web sites of the top 100 pharmaceutical brands and concluded that the FDA needs to exercise more control over how these sites look rubbed us the wrong way. The paper, called “Manufacturers' prescription drug web sites: A gray area of discourse and ethics,” was presented at a conference in June. If the study’s on the Web, we couldn’t find it.

A few words on the wrong rubs.

First, women do most of the health-related shopping in the U.S., and few of them – or so says the Pink Study – get their information about a drug from the brand’s Web site, so is there a excessive reason to be alarmed? The Pink Study, primarily of college-educated ladies, showed that these women rely on their own research to get the answers they need about prescriptions they’re received. While the web may be one source of information, it is not the sole source of the information.

As for others who visit the Web site: Presuming that consumers will be misled by information they read on the site presumes that all consumers are stupid. This we believe is an assumption our FDA believes is true.  Even the study authors – from Dartmouth and the University of Minnesota -- want the drug information pages to be tagged with a genre name such as “infomercial.” But do people realize that most if not all the content on a drug web site is regulated?  The content needs to be "fair and balanced" according to the FDA; the industry spends a lot of money to hire attorneys to make sure this happens.

But in all fairness, maybe we're shooting the messenger here. While we understand the FDA's need to protect the American consumer from inaccurate, false and misleading information, might the study's findings also be a reflection of the agency's regulations? If the study authors understand that the FDA controls the content, the study doesn't reflect that. The FDA sets policy, and it's FDA policy or lack of leadership that skews content in this way.

Yes, some of the fonts on the Web sites are small, there’s no question about that. It would not be a big deal for the FDA to say: Make it 18-point, or something like that. But what is needed here is leadership, something the FDA doesn't seem to want to provide companies with that it regulates, or what the American consumer may want.

Something else bothered us about this whole thing, but it had nothing to do with the study. It had to do with the way the press covered this story. There was a time when the press made an effort to get both sides of the story. Not here. After putting the title of the paper in Google, we searched all the entries. Not one media outlet that covered the release of the study called any industry member for comment.

Not sure if that’s a sign of the quality of journalism today, or an indication of industry’s reputation. Either way, it’s not good. Food for thought as marketers try to get a handle on their marketing channels.

Monday, August 9, 2010

Physicians, Conflicts of Interest, and Wishful Thinking

A PostScript blogger seemed surprised about study results showing that a majority of doctors in hospitals in the Mount Sinai School of Medicine consortium were okay with accepting meals and small gifts from industry. According to the study, which appeared in the Archives of Surgery, 72.2% had no problem having lunch on pharma’s dime, and 25.4% were good with accepting gifts. Again, if gifts and lunches are having such a deleterious effect on patient care, where is the outcome data to suggest this assertion?

PostScript surveyed doctors as well. It found: “Despite [the] sea change in public and governmental attitudes during the last several years, the physicians surveyed retain generally positive attitudes toward many industry gifts, and more than two-thirds still find gifts and lunches from industry acceptable. In fact, our findings are remarkably similar to results of other studies of physician attitudes toward industry from as early as 2001….”

Did the purists expect change would happen right away once states instituted conflict of interest guidelines and regulations? The answer is yes, but it is not happening fast enough for some.  Take a look at some of the various medical associations listed on Pam Pohly’s Net Guide: Industry-physician relationships are alive and well. Look at the amounts companies are reporting on their own compliance Web sites for payments.

This relationship is not easy to untangle. Yes, industry is selling drugs and devices, but they are developing drugs and devices, too, and physicians are interested in the science of how this happens. In fact, many of them are the ones driving this forward.  Many universities are receiving significant royalty payments for work done in their labs as a result of these talented physicians.  For its part, industry is not in the clinic – it needs to hear that side of the story.

And there is prestige in being a sought-after Key Opinion Leader; anyone who has ever sat in an advisory board can see the pride these physicians take in being asked and in giving their opinion. If they don’t like a drug, they generally say so. If they do not think it should be developed, companies typically will not develop the drug or device.

The PostScript blog says that the culture of medicine must reject “industry marketing interactions more fully” before physicians’ attitudes will concur with the public’s stance on conflict of interest. Our point of view is that while culture may change the course of behavior in medicine, people need to ask: What are the consequences to the advancement of medicine if practicing experts are not able to give their opinions to drug and medical device developers? Who will launch these innovations? 

Saturday, August 7, 2010

Global Forces: Learning to Read the Tea Leaves

“If senior executives wait for the full impact of global forces to manifest themselves at an industry and company level, they will have waited too long.” So writes the McKinsey Quarterly in “Global forces: An Introduction.”

Not too long ago, it was Macy’s and Gimbel’s, within virtual walking distance of one another, slugging it out for the customer’s attention. Now, companies compete across time zones – with more differences than just those seen on clocks -- like political, social, economic, and religious differences.

The McKinsey article points out five trends that companies must pay attention to to stay alive, and thrive, in this type of business world. They are: extensive, emerging market contributions; developing certain economies’ productivity imperatives; interconnectivity of the global grid; pricing of available resources; and maintaining social stability in a globalized world.

In a survey of more than 1,400 company executives, it’s not surprising that what McKinsey calls the great rebalancing – the emerging market contributions – that is the trend which executives consider the most important for their businesses to aware of. 85% said it’s important for business; 48% said it will affect profits; 72% said their companies are pursuing these markets. According to McKinsey, these emerging-market companies will “contribute more growth than the developed ones” in the next few years. The impact: new middle-class consumers, new product designs, value chains, and market infrastructure.

The question is: How can pharma reach customers in parts of the world that are, by U.S. standards, still undeveloped? To their credit, some industry members have allowed royalty-free manufacturing of their retroviral drugs in poor countries, if not outright free distribution. That’s excellent name recognition, but certainly not enough to win lifelong customers.

Industry will need to be more savvy in these new markets, learning the culture while making itself aware of what the competition is doing at the same time. He who naps, loses.

Here’s a thought: Put pictures of the GM, Ford, and Chrysler logos above your computer, along with this story’s lead-off quote. That could help.

Wednesday, August 4, 2010

Foreign Clinical Trials: Bye Bye, U.S. Trial Investigators

Can we say for certain that industry is conducting more clinical trials overseas because fewer U.S. physicians, who once ran those trials, don’t want to see their remuneration made public?

Probably not, but what we can say is this: It is a factor.

A week before the Inspector General of the Department of Health and Human Services published his report saying that most drugs approved in 2008 were based on trials conducted in foreign countries, Pharmalot published a survey, conducted by the Association of Clinical Research Organizations.

ACRO found that between 2004 and 2007, the number of FDA-regulated trial investigators was dropping in the U.S. and Europe, and climbing in Eastern Europe, Asia, and Latin America. The reasons cited: medical liability, COI rules, and regs that physicians must publish financial relationships – 24% of U.S. investigators were “less likely” to be involved if they had to disclose what they made. U.S. investigators are more interested in making money than their peers in Western Europe – 68% vs. 26%, according to the report.

For those of you who missed the IG’s report: It looked at 121 approved drug applications. Of these, 80% “contained data from foreign clinical trials.” The vast majority of trial participants were not Americans. The vast majority of sites were not FDA-inspected.

This trend is expected to continue, and expand into countries like China. The FDA didn’t inspect sites in countries where political relationships are generally just fine; are we going to get into China? In 2008, the FDA examined .7% of foreign clinical trial sites, and 1.9% of domestic sites. And that, of course, is if the company has even filed an IND. The “FDA may be unaware of some ongoing, early-phase clinical trials because sponsors are increasingly conducting early-phase clinical trials outside the United States without INDs,” the report said.

The agency agreed with the IG’s recommendations to improve the situation, including standardizing electronic data filing and creating inspection agreements with oversees regulatory bodies. Anyone remotely aware of the problems involved with conducting clinical trials these days knows it will take more than the IG’s recommendations to reverse the overseas trend.

Here’s an idea on paying U.S. clinical investigators: Perhaps the solution calls for something like a blind trust. All those industry members conducting clinical trials in a particular year would throw money in a pot, and clinical investigators would be paid from that pot. Their names would be published, but not aligned with any one drug, or industry member.

Is it a dumb idea? Maybe. But we need ideas. Dumb ones can spawn good ones.

Transparency is all well and good, but as we’ve said before, we need to find ways to keep industry and physicians working together, or the medical progress we’ve enjoyed will be compromised.