Wednesday, March 26, 2008

The Big Business of Patient Privacy

There is a booming business in America of selling patients fear and telling them there is a massive privacy problem. Fear is worth millions of dollars to individuals who run “privacy” groups.

This started a year or two ago. Patient privacy rights groups started a campaign of telling outright lies to instill fear in people. These lies include the notion that the government, insurance companies and drug companies are engaged in a vast conspiracy to expose private patient medical information. The root of this view is that HIPAA is completely worthless and only these patient privacy rights groups possess the knowledge to truly protect patient privacy.

The patient privacy rights groups claim that all data can be “easily re-identified” with only three pieces of information: zip code, sex and age. If you are a 59 year old man living in zip code 37205, then your name must be Al Gore…because there can only be one 59 year old man in that zip code (there’s at least one other 59 year old man living in that zip code and probably many, many more). Obviously it’s absurd and the patient privacy rights folks know it. But it doesn’t stop them telling lies or selling fear.

Why the big business? You can make more money selling fear than you can as a physician. It takes a lot of money to have houses in multiple states and swanky condos in Washington, DC. It takes a lot of money to jet around to “privacy conferences” and lecture about the “risks” to patients (conveniently ignoring that those “risks” are the fabrications of individuals with ulterior motives). Many of these conferences take place at tropical beach resorts or ski chalets.

How do the patient privacy rights groups make money? The leaders are on the lecture circuit and sell their consulting services to organizations and their “expert” testimony to trial lawyers. But their most recent program is truly insidious. In my day, we called it a shakedown or extortion, but they call it “certification.”

The patient privacy rights groups start by telling lies about a specific company or organization. They then have a meeting with a company and tell them that the only way the lies will stop is if the company goes through the certification program (which obviously has costs associated with it). And low and behold, the patient privacy rights groups claim that the companies are fully complaint and get the gold star of approval.

But here’s the rub, there was never a problem to begin with. The companies were fully complaint with existing law and company policies often exceeded federal standards. Patient information was never at risk. EVER. But this hasn’t stopped these patient privacy rights groups from advancing an agenda to extort money from companies.

If you think back, the breaches in patient privacy in American haven’t come from a conspiracy of insurance companies, drug companies and the government flying around in black helicopters together and using secret technologies derived from secret government programs. It comes from doctors, nurses and hospital staff snooping (illegally, I might add) into hospital computer systems. Britney Spears privacy wasn’t breached by the government, a drug company, a data miner or an insurance company. It was a group of doctors and nurses looking to make a quick buck at selling her personal information. All the privacy protections that these privacy rights groups advocate for will never stop that. That is the real privacy problem. The issue is not electronic databases, it’s the people who deliver the care who are corruptable.

No patient has died or was harmed because their health information was stored in an electronic database. I’d challenge the patient privacy rights groups to prove otherwise. Yet there are countless examples in the literature of instances where patients could have been saved or not harmed through EMR/EHR technologies. Privacy is important, but so is rational thought. Just because the patient privacy rights groups sell fear and ignorance doesn’t mean you need to buy it.

Tuesday, March 25, 2008

Universal Health Coverage Doesn’t Mean Universal Health Care

As I have discussed in this column before, universal coverage for medical expenses doesn’t mean universal access to health care. Patients commonly confuse the two and politicians are more than happy to oblige because it scores the easy votes with the AARP crowd.

On a recent trip to Europe, there was a major news sensation because women had finally started complaining that they were not receiving adequate coverage for breast cancer. In Ireland, the media report that from the time a woman requests a mammogram until she actually gets one ranges from 5 months to 2 years. If you actually detect a possible lump, you get expedited care (usually about 4 months) [See BBC] In the UK, it’s a bit better at around 3-6 months. In the U.S., it’s usually less than week.

In the United States, if a woman had to wait months for mammogram, the Susan G. Komen drones would go absolutely jihadist and lead a revolution. There would be protests the likes of which this country has never seen and would make ACT-UP look like the elementary school drama club. It would be organized, loud and very, very ugly.

Women should take heart that their sisters in Europe are finally getting sick of this. But their sisters in Europe don’t really have a choice – they live in systems of “universal healthcare.” So they have three choices – wait it out, pay huge amounts of money at private clinics or travel to the United States or other medical destinations for quality (and timely) medical care.

I’d love to have free healthcare. But I’d like to have the health care when I really need it. I don’t trust my insurance company to do what’s in my best interest. But I trust my government even less.

Monday, March 24, 2008

New York Times Pushes for Academic Detailing

In last week’s editorial on “counter-detailing,” the New York Times has launched its latest volley against the pharmaceutical industry. No real surprises here.

However, I’m embarrassed that the New York Times gets it so wrong (although it doesn’t really surprise me). The essence of the New York Times Editorial is an endorsement of Jerry Avorn’s attempt to institute national-level counter-detailing against the efforts of those vile pharmaceutical reps.

Avorn’s been on this kick for decades and has been unable to demonstrate in a peer-reviewed setting that his theories actually work. While testifying under oath, he himself has acknowledged his ideas are idealistic at best and would require billions of dollars to actually be successful. I wonder if Herb Kohl is willing to invest billions of dollars with no proof of concept. I doubt it.

But I digress. The New York Times has editorialized, “With comprehensive, unbiased information, doctors should be more likely to prescribe the best drug for a patient, not necessarily the newest, high-priced drug that is being pushed by a drug company sales representative.” The “unbiased information” is where the Times gets it wrong.

I’m willing to support academic detailing and I think truly unbiased information is what we should all be striving for. Unlike the New York Times, I don’t believe that stifling anyone’s speech is ultimately in the best interest of patients. And unlike the New York Times, I don’t think that suppressing information is helpful to doctor’s in determining what is in the best interest of patients.

Insurance company giants have lobbied the folks at Harvard around the content of their academic detailing program. Many of the “unbiased” medical experts get the official Gold Seal of Approval from the nation’s largest and wealthiest HMOs. The insurance company’s interests are not “unbiased information.” It is purely cost containment – and anyone who has been around since the early 1990s (or seen Michael Moore’s movie SiCKO) knows that HMOs don’t exactly have patient’s best interests at heart. The New York Times must have missed this in its quest for “unbiased information.”

I’ll support academic detailing, but only if it isn’t a rubber stamp on HMO’s attempts to ration care and shift the entire cost burden onto patients while they pay record bonuses to their CEOs.

Thursday, March 20, 2008

Nigeria to Interrogate Pfizer ex-CEO

NGO’s and advocates like Bono are pushing companies to invest in Africa and forgive African debt. Health advocates like the Bill and Melinda Gates Foundation want companies to invest in research for tropical and emerging diseases that impact Africa and other tropical and lesser-developed areas.

Against this backdrop, you have African nations like Nigeria that are waging war on pharma. Nigeria wants to interrogate Pfizer’s ex-CEO Bill Steere. Countries are also looking to invalidate patents and break intellectual property agreements.

Nigeria’s issue is that Trovan was tested in children in Nigeria at the height of a cholera epidemic. Some children were born with deformities and some died, however causal link to Pfizer’s Trovan has not been established. Nigeria contends that Pfizer tested the drug in the country illegally. Pfizer maintains it received all proper government approvals.

The public interrogations and trial are scheduled for mid-April. I’m looking for Pfizer to bring forth evidence showing proof that government officials signed off on the tests. I’m also looking for Nigeria to then assert that either 1) the officials lacked authority or 2) claimed that Pfizer bribed the officials. Nigeria’s real aim is to use this as bargaining chip with pharma companies and the U.S. government, not to prove that Pfizer ever actually did anything illegal.

Given this, some pharma companies (at least two that I know of) are considering dropping current research programs aimed at tropical and emerging diseases. Why invest in Africa if you’ll be punished for it?

Wednesday, March 19, 2008

Takeda To Take TAP In-House

Takeda is offering about $5 billion to purchase Abbott’s stake of their U.S. joint venture. TAP has marketed two blockbusters – Prevacid and Lupron – but has recently stumbled.

Meanwhile, Takeda has been trying to grow its own organic presence in the U.S. Takeda will be getting TAP’s reps and its building north of Chicago.

Pharma M&A

It looks like we’re in for another round of M&A activity.

According to JP Morgan, AstraZeneca is looking to acquire Shire. We also have rumors of Johnson & Johnson looking at Sepracor. And Amgen is desperately looking for anything to reverse its slide.

However, buying revenue won’t boost pipelines. And that’s the real challenge.

Monday, March 17, 2008

Has Pharma Hit the Bottom?

The news last week out of IMS Health was sobering. The pharma industry in the U.S. grew an anemic 3.8% in 2007, totaling $286.5 billion. While that seems like a whopping big number, it’s still pretty small when you figure that pharmaceuticals are only about 10% of the entire healthcare spend (estimates range from 9-12%).

IMS says the meager sales growth is from the increasing number of generics, a rash of patent expiries of blockbuster drugs, a trickle of FDA approvals reflecting the agency’s new stance on risk-vs-benefit, and massive safety issues in 2007.

“In 2007, the U.S. pharmaceutical market experienced its lowest growth rate since 1961,” said IMS’s Murray Aitken, Senior Vice President of Healthcare Insights. “The moderating growth trend that began in 2001 resumed last year following the one-time impact on market growth in 2006 from the implementation of Medicare Part D. Last year, we saw a continuing shift away from primary care classes to biotech and specialist-driven therapies, which grew at a 9 percent and 10 percent pace, respectively. Among the leading therapy classes, oncology drugs continued their rapid growth, at 14 percent — the result of innovative new medicines, expanded indications and accelerated uptake of products to fill unmet needs.”

In financial markets, you usually hit the bottom when the news is the worst. And the news can’t get much worse for pharma. Could 2007 be the bottom of pharma’s decline?