Latest Drugwonks' Blog

BIO's Seven-Year Itch

07.02.2009

Suffering from the seven-year itch?

Consider what Steve Usdin of BioCentury has to say on the subject of biosimilars in the wake of the recent Federal Trade Commission (FTC) report.

“A Federal Trade Commission (FTC) report released last week, and the responses to it from members of Congress and industry, demonstrate that the prolonged debate has not diminished the controversy over the best ways to balance incentives for biomedical innovation with the economic benefits to patients and payers that could be produced by a robust biosimilars market.

The FTC flatly rejected arguments the Biotechnology Industry Organization (BIO) has made to justify its contention that a 14-year exclusivity period for pioneer biologic products is essential to ensure the future ability of companies to attract capital and to invest in new product development.

Indeed, all four FTC commissioners signed off on the report, “Emerging Health Care Issues: Follow-on Biologic Drug Competition,” which argues there is no need for any market exclusivity for pioneer biologics beyond that provided by patents, save for products for Orphan diseases and unpatentable drugs.”

Ouch.

According to the FTC, “There is no evidence that patents claiming a biologic drug product have been designed around more frequently than those claiming small molecule products.”

Double ouch.

Usdin’s complete article is worth a careful read.

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Samson Forever

07.01.2009

Samson, my yellow labrador and constant companion for 14 years, passed away this morning. Just wanted to share a couple of photos and one of my favorite poems to let everyone know who he was and what he meant...

The House Dog's Grave (Haig, an English bulldog)

I've changed my ways a little; I cannot now
Run with you in the evenings along the shore,
Except in a kind of dream; and you, if you dream a moment,
You see me there.

So leave awhile the paw-marks on the front door
Where I used to scratch to go out or in,
And you'd soon open; leave on the kitchen floor
The marks of my drinking-pan.

I cannot lie by your fire as I used to do
On the warm stone,
Nor at the foot of your bed; no, all the night through
I lie alone.

But your kind thought has laid me less than six feet
Outside your window where firelight so often plays,
And where you sit to read--and I fear often grieving for me--
Every night your lamplight lies on my place.

You, man and woman, live so long, it is hard
To think of you ever dying
A little dog would get tired, living so long.
I hope than when you are lying

Under the ground like me your lives will appear
As good and joyful as mine.
No, dear, that's too much hope: you are not so well cared for
As I have been.

And never have known the passionate undivided
Fidelities that I knew.
Your minds are perhaps too active, too many-sided. . . .
But to me you were true.

You were never masters, but friends. I was your friend.
I loved you well, and was loved. Deep love endures
To the end and far past the end. If this is my end,
I am not lonely. I am not afraid. I am still yours.

Robinson Jeffers, 1941

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The Foreclosure Myth: Why Millions of Americans Arenâ€™t Really Losing Their Homes to Medical Bills

06.30.2009

It is presently in vogue to blame most any problem or set back on health care costs. And why not? After all, telling Americans that they are one illness from being bankrupted and landing on the street is an effective strategy for getting them to support your solution. A couple weeks ago, I explained in depth why you should not trust statistics that claim that more than 62 percent of bankruptcies in the US are medically linked. But there is another statistic that is popping up here and there, that 1.5 million Americans will lose homes this year due to medical costs.

This number comes from an article by Christopher Tarver Robertson, Richard Egelhof and Michael Hoke published last year. You shouldn’t be surprised that the authors thank Elizabeth Warren, one of the authors of the flawed studies on bankruptcy and medical bills, because they have made precisely the same mistakes.

First, the authors report that 49 percent of the people surveyed, all of whom were on the brink of foreclosure, said that the situation “was caused in part by a medical problem” (emphasis original). Of this group, 32 percent cited illness or injuries, 23 percent pointed to high health care costs, 27 percent indicated time off from work, and 14 percent mentioned time spent taking care of someone else in their family.

The authors then add those who meet a host of other criteria to reach a total reported figure of around 7 in 10 foreclosures being caused in part by health care costs. Again a low threshold of medical bills ($2,000) and being out of work for two weeks in the last two years are among the criteria used to classify addition foreclosures as medically linked.

To begin with, it is unclear what exactly the first category, “illness or injury,” covers since both the costs and the lost wages that are the financial consequences of ill health are included separately. The $2,000 threshold is far too low to meaningfully measure whether medical bills were a serious contributor, especially in the absence of information about other debts and costs. Nor is this above the average out of pocket health expenses for a typical American family. And, as I have argued before, time spent out of work, whether for one’s own illness or to care for someone else, is not directly linked to the health care system but to larger social policy issues.

Second, the study also includes gambling, addiction, birth, and death in at least some of the calculations of which foreclosures are health care related. The health care expenses associated with the latter two belong with other medical costs. The expense of treating the former two could arguably be included as health care costs, although this is debatable, but the money squandered on such habits certainly should not be.

Third, the study relies on self-reporting by the home-owners and had a very low response rate (about 7 percent) or 128 responses, creating significant potential for bias or over reporting. Attempts to control for this were inadequate and rather cursory. Finally, the article looks at only four states and then generalizes from them.

As in the case of bankruptcies, other studies have shown significantly different results and the authors admit that “most debtors cited one, two, or three other, completely distinct causes of foreclosure.” Given that the people surveyed are those already stretched by multiple debts and expenses, placing blame on medical costs is simply inaccurate in many, many cases.

You can read the whole article here.

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No Social Media Please, We're Pharma

06.30.2009

Ambiguity is a virus. When it comes to social media, the more the FDA says about what is and what is not “in compliance” vis-à-vis social media, the less we seem to understand – and more conservative we become. This is not the right answer.

The right answer is to understand the medium and use it to advance both the public health and specific marketing objectives. The two are not mutually exclusive.

Let's take blogs as our example.

Blogging is a potent weapon in both the war of ideas and the marketplace of communications. Blogs are wonderful tools when used appropriately. They are pithy, witty, and timely. A wonderful triple play – but counter-intuitive to many pharmaceutical marketing cultures. Brevity is the soul of wit – but not necessarily of medical marketing.

The tools of the blogosphere are immediacy, emotion, humor, asperity and acerbity. “Let me ponder the nuances of your argument” is just so 20th century. The best bloggers are both incisive and sassy. Blogs act as message accelerators. While a good Op-Ed is absorbed, a timely blog is injected, main-streamed into the collective consciousness of a variety of interconnected audiences. Good blogs resonate.

How can healthcare companies take advantage of this phenomenon? One word – engage. But engage carefully. Legal and regulatory issues abound, but a smart place to start is to spend quality time identifying which blogistas are the most relevant to a product or an issue or a company and then read them every day throughout the day. The best blogs are updated more than once a day. It's hard work, but it's worth it. And, relative to metrics, it isn't the top 10 – it's the right 10.

Blogs are the new frontier of pharmaceutical communications. The best bloggers are activist, educated, unpaid, unprompted and uncontrolled. Blogs are real-time focus groups without either the design or permission of the sponsor. Its voyeuristic marketing – wonderfully, terribly, brutally naked in both honesty and utility. The medium is the message.

And the message is being regularly trawled by the mainstream media for “what's next.” I blog every day and regularly get calls from “traditional” journalists to discuss what I'm saying and where I think its going. And if your cognitive mapping is having a hard time accepting this proposition – ask Maureen Dowd.

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Going "Open Kimono" at the FDA

06.29.2009

Some interesting tidbits from the FDA’s June 24^th meeting on the issue of transparency.

“FDA should make it obvious, to those who are interested, how scientific data leads to its approval decisions.” -- PhRMA Assistant General Counsel Jeffrey Francer. As an example, Francer pointed to FDA approval decisions that do not track with advisory committee recommendations. "That's often confusing, not only to those of us in industry, but people generally."

Absolutely. But, since transparency cuts both ways, wouldn’t it be equally beneficial for pharmaceutical companies to proactively release complete response letters received from the agency once a final action has been taken?

Transparency thrives in an atmosphere of clarity. And that was also a topic of conversation.

BIO’s Director for Science and Regulatory Affairs Andrew Emmett, commented that the FDA does not meet and communicate with firms on a consistent basis early in the development and review process. He urged, and appropriately so, that the agency work with industry to minimize barriers to such meetings.

Emmett also called for the agency to provide more information so industry can understand how FDA makes decisions. There needs to be "regulatory transparency and clear articulation of FDA's policies and expectations."

Since it can take several years for FDA to finalize guidance, "This leaves companies to ascertain FDA policy by interpreting the agency's regulatory decisions and enforcement actions, which is an inefficient way for industry to understand and meet the agency's regulatory expectations."

If we’re going to go “open kimono” on this, then the real 800 pound gorilla in the room is the fact that many inside the FDA prefer to leave guidances in draft form – because that ambiguity gives them almost unlimited and perpetual power. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.

Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.

FDA transparency cannot be achieved without FDA predictability. Predictability is power in pursuit of the public health.

On a related note (and at a different venue – the annual DIA meeting in San Diego), Sandy Kweder (Deputy Director, FDA Office of New Drugs) and Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) discussed the need to begin REMS conversations as early as Phase II. Dal Pan commented that "REMS are as new for us] as they are for all of you. It's not that we hold some secret and we're just not telling anybody about it. We're all navigating through this and trying to figure it out.”

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(Dr.) Kit and Kaboodle

06.26.2009

Looks like the FDA is getting down to some serious social science

According to the Pink Sheet, a study proposed by FDA to evaluate how benefit information is conveyed through direct to consumer advertisements could end up showing drug marketers how to describe "high" and "low" efficacy drugs.

The proposed study will evaluate how consumers' interpretations of a drug's efficacy after viewing DTC ads compare to the efficacy data in the product's label.

The study will be conducted in two concurrent parts - one looking at print ads and one at TV ads - and examine three factors: drug efficacy, visual format, and type of statistic.

The agency defines drug efficacy as a quantifiable, objective metric that can be conveyed in graphical representations of the drug versus placebo, with "high efficacy" meaning "noticeably better than placebo" and "low efficacy" meaning "minimally better than placebo."

The agency traditionally has discouraged companies from making such qualitative claims - or even making too much of quantitative numbers - in its advertising. But the proposed study endpoints suggest a growing FDA comfort with, and even an interest in, consumers receiving this kind of information.

Testing Pfizer-like pictographs

The study will examine graphs, pictographs and pie charts as ways to visually present that efficacy information, and whether statistical information is best conveyed as frequency, relative frequency, or percentage.

The test product will be for a cholesterol treatment and modeled on an actual drug, such as Pfizer's Lipitor (atorvastatin), with labeling used as the reference for defining efficacy levels and the objective metrics for clinical performances.

The study will include 4,500 participants, 2,250 in each group (television or print). The subjects will read or view one advertisement version, and then make a series of judgments about the drug in a 20-minute interview.

FDA first will test whether, within each format, the participants were able to distinguish between low- and high-efficacy drugs. Then, it will look at whether the participants' efficacy estimates differ across formats and how accurate the estimates are.

Comments on the proposed study, called "Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisement for Prescription Drugs," are due by Aug. 21.

All to the good. And it sure beats the ignorant "drug facts box" – the a la nutrition facts panel idea,that’s being kept alive via legislation introduced by Senators Jack Reed (D, RI) and Barbara Mikulski, (D, MD) which, BTW, would also require comparative effectiveness information to be included in product labeling.

Vey izmir.

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Between a Roche and a Hard Place

06.26.2009

What's the difference between PhRMA and BIO?

Roche.

Roche is leaving the Pharmaceutical Research & Manufacturers of America trade association effective June 30.

Roche describes the action as a "business decision" by "the newly combined Genentech-Roche US commercial organization."

According to the Pink Sheet, "As a practical matter, the departure will add to the strain on PhRMA for resources as it works on all fronts to build alliances and promote its reform agenda. The pending mergers of Pfizer/Wyeth and Merck/Schering-Plough will further reduce the group's core member base. The association traditionally adjusts dues following periods of consolidation."

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Looking beyond Europe: Health care in Japan

06.25.2009

From the discussions of how American car companies are put at a disadvantage because they have to pay health insurance costs that firms in other countries avoid, it isn’t surprising that many people have concluded that health care systems in these nations are single payer. In fact, neither Germany nor Japan, two of the countries most commonly cited in this connection are government run or paid. I have already discussed Germany on several occasions, today I want to talk about Japan.

The Japanese health care system is rather complicated, with different, somewhat interlinked, plans for citizens depending on their employer and stage of life. Japan’s Employee Health Insurance Program obligates any business with 700 or more people working for it to offer health coverage to its employees. About 85 percent of companies essentially self-insure. For these companies, around 8.5 percent of payroll goes to health care and employee and employers split the cost more or less in half. Around 26 percent of people in Japan fall under this part of the system.

Companies with fewer than 700 employees participate in a federal, health insurance scheme for small businesses, run by the state. Approximately 30 percent of Japanese are in this group. Small companies pay about 8.2 percent of payroll and the state then puts in additional money.

Those who are self-employed fall under the government’s Citizens Insurance Program. It is managed by municipal rather than national authorities and is paid for by a self-employment tax, taxes on insurance companies and the government plan for small businesses, and, when necessary, direct government contributions. Those who are unemployed retain the coverage they had while working.

Finally, the health coverage for the elderly is called Roken and does not have separate financing of its own but is paid for by money from the other three parts of the system and government money. Private health insurance is possible, but rare.

In addition to taxes and the percentage of their wages they pay out for health care, people in Japan also have significant co-pays, usually around 30 percent, and other out of pocket costs for medical services. There is a ceiling on co-pays, for a middle class family, it is about $677 a month, and a normal family spends around $2,300 in a year on medical care in addition to what they pay through work. Out of pocket costs amount to about 17 percent of annual medical spending.

Japanese hospital and medical facilities are usually privately owned and operated. Small facilities tend to belong to one doctor or family, even those carrying out advanced procedures. Hospitals and doctors in private practice usually get paid a set amount for each treatment or other service and drugs also cost the same throughout the country because the prices are determined by the government.

That doesn’t mean that some people haven’t figured out ways to game this system. In some cases, doctors have bribed government officials in charge of setting fees. Doctors also benefit from ordering unnecessary tests and from seeing as many patients as they can in as little time as feasible. As a result, “two-thirds of patients spend less than 10 minutes with their doctor; 18 percent spend less than 3 minutes.”

The upside of health coverage in Japan is that it includes almost everything, sometimes reimbursement for travel expenses. Patients can go to any doctor or hospital and usually they do not need a referral or approval from a primary care physician to see a specialist. Technology is highly advanced and very accessible. And, because the cost is the same everywhere, medical facilities compete on the basis of quality or having the latest treatments. Some top hospitals do end up with queues, however, and some people pay illegally to jump to the head of the line.

Contrary to the situation elsewhere in the world, many argue that Japan needs to spend more money on health care, which consumed about 8.2 percent of GDP in 2005, less than similar systems in Europe or the US. However, the system is strapped for cash with the costs of care outstripping what is paid in. Further, people in Japan go to the doctor a lot, especially the elderly who pay less out of pocket for their care, whether for minor complaints or just to chat. This is particularly a problem because the elderly account for a staggering 90 percent of the growth in health care costs and are steadily rising in number, producing fear for the future of the system.

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What Don't They Get About Govt Run Healthcare

06.25.2009

From an oped by Paul Duncan

"To be sure, if the same public program that competes with the private entities also gets to write and enforce the rules of the competition, that might create a problem. But almost all serious observers anticipate that the public program alternative currently being proposed will not also control the regulatory framework in which services are offered; it will simply be available as another option, and will survive only if it can succeed as a genuine alternative to those private companies. "

Read Op-Ed here.

Can we say delusional?

Let's take a look at how public plans work here and around the world. Do they compete like the postal service (oh sorry, no real competition) or do they set the prices and lowball providers and then just expand budgets in response to demand generated at taxpayer expense without regard to profitability, waste, corruption.

Does Medicaid compete? Medicare? How about the Indian Health Service?

Further, we already have public options such as Medicaid and SCHIP. What we don't have are more private choices that promote prevention and well-being and that should be the point of reform.

Making the government the lowball option is a bait and switch that will eliminate individual choices of health care plans. Why? Government's can tax and spend without the timely accountability that only a private choice based system protects.

Aetna's profits declined this year because it lowered prices to gain market share even as it spent more on medical services, disease management and prevention. Reform should encourage more of this and build on such efforts rather than kill them.

That's what is at stake. And more.

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Buenos DIA

06.25.2009

Just returning from San Diego and the 45th annual Drug Information Association (DIA) conference where I participated on a panel about how to improve FDA communications. It was only 90 minutes long and we didn't solve all of the world's problems -- but there was some forward motion.

The panel was chaired by the always alert Julie Zawisza, CDER's Director of Communications and I was joined on the dais by Ray Kerins (Pfizer) and Steve Usdin (BioCentury).

We coverered a lot of ground, but what really was on the mind of the audience was the FDA's stance (or lack of one) on issues related to social media. We talked about DDMAC letters and the risk communications advisory committee, blogging, Facebook, Twitter -- and yes, even Cheerios. And the general consensus was that the agency was behind the curve.

I know, duh. But that's when Julie Z. stepped up to the plate with the following comment, "The FDA has no intention to stiffle the use of social media." It might have sounded like a throw-away line -- but if that sentiment is genuine (and Ms. Z, is as genuine as they come), then there's hope for FDA to be both regulator of and partner in using social media to communicate important public health information. In fact, Julie said (twice) that she was going to talk with Janet Woodcock about holding a series of external meetings on the subject of "Web 2.0."

She also, aptly, pointed out that when it comes to understanding, regulating, and using social media channels, it's important to understand that "it's not just information, but context and perspective."

You go girl.

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Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.