Katrina Part II

I just returned from the South. The situation in Florida is deteriorating fast. The Federal government is bringing in waves of Haitian immigrants into Florida hospitals for medical treatment. Wait times are up for appointments. Already over-worked nurses are being asked to do even more. Hospitals are struggling to keep up with the load. And the State of Florida is being asked to shoulder the financial burden for the U.S. Government’s response.

The tragedy in Haiti is catastrophic. And the United States has the moral duty to assist in every way possible. Unfortunately, there is a Failure of Leadership in this crisis. The Ivy League brain trust in President Obama’s Administration hasn’t made any arrangements with Florida on how to manage this. So, it is leaving the State of Florida to shoulder almost the entire financial burden of the medical relief efforts for Haiti (as well as all of the logistical considerations). It’s not right to ask a State to perform the job of the Federal Government. It wasn’t right with Hurricane Katrina. And it’s not right with the earthquake in Haiti.

There is a failure of leadership at the Federal level to handle the Haiti relief efforts. Readers of this blog know that I’m not a fan of HHS Secretary Kathleen Sebelius. Frankly, Elmo from Sesame Street could have more of an impact, but since she was a major backer of then-candidate Obama, we’re stuck with her. Sadly, the response from President Obama hasn’t been any better. He’s struggling to keep his head above water (and bring up his sagging poll numbers) with domestic initiatives, so he can’t focus on the Haiti situation. The crisis isn’t going away.

Today, the New York Times has reported that the U.S. military has stopped medical evacuations out of Haiti because Florida hospitals refuse to accept new patients. This also isn’t the answer. The U.S. needs to spread out the Haitian patients across the healthcare system to lessen the burden on individual hospitals. And, as loathe I am to admit it, the Federal Government needs to shoulder the financial burden – now. It might mean fewer lavish, tax-payer funded vacations for the Obama family to Martha’s Vineyard or Hawaii, but it is necessary. The Haitian earthquake is Obama’s Hurricane Katrina. How will he respond? This situation needs real leadership, real fast.

A Tale of Two Recalls

On November 16, 2007, I wrote a blog post “If Tylenol Happened Today.” In observing Johnson & Johnson’s new corporate position of attacking the American Red Cross and suing it for trademark infringement, I noticed that Johnson & Johnson had undergone a major cultural shift from the J&J of 1982. I observed that the creedo was greedo. I speculated what would happen if a Tylenol-like problem would happen again. I never realized how right I would be.

Since that day, the Tylenol situation has happened again – and again it was J&J’s Tylenol. Many batches and lots of Tylenol (and now many, many other J&J products) contain a funky, moldy odor that has made some patients sick.

In my blog posting, I talked about J&J’s adoption of “Slow Cooking” – their new approach to communications and crisis (“Slow Cooking” is how the company itself describes its approach). In 2007, I said, “When your products are a matter of life and death, you don’t have luxury of taking your time. Communications can’t be a ‘J&J by the way’ afterthought; they need to be fully integrated into your overall strategy.”

And now we can see the implications of The New Johnson & Johnson. When the latest round of Tylenol product problems first emerged in 2008, the company waited over a YEAR to report it to the FDA – and even then the company was dismissive of patient claims of adverse events. Even then, the company did not aggressively recall the product (as they did during the Tylenol recall in 1982). A year after problems with Tylenol emerged (in December 2009), the company began recalling some products – very slowly. This is the J&J Slow Cooking approach.

This response completely validates my comments back in 2007. At that time, I wrote: “If the Tylenol tampering occurred today, we would be looking at a response that would have taken weeks or months, not days.” I was wrong. The J&J response didn’t take weeks or months – it took months and now potentially years.

Since Johnson & Johnson’s culture of integrity has failed, the FDA has weighed in and issued the company a warning letter for failing to take these problems seriously. J&J has two weeks to respond back to the FDA.

Pharma’s Response to Haiti

Like most of the world, at Pharm Aid we’ve been watching the aftermath of the earthquake in Haiti. Pharm Aid has done its part in donating to the American Red Cross and Doctor’s Without Borders (both groups are on the ground in Haiti providing assistance).

But I was curious how some of the pharma companies had responded:

Amgen has donated $2 million. Merck provided an immediate donation of $350,000 in cash, plus another $200,000 in products. Eli Lilly is donating $250,000, plus another $250,000 from employees. Bristol-Myers Squibb has donated $200,000. AstraZeneca has donated $160,000.

GlaxoSmithKline (GSK), Pfizer and Abbott are providing in-kind donations of medicines, although they have not quantified those donations.

Johnson & Johnson, which sued the American Red Cross in 2007 over its logo, has made some contributions to other groups, although they have not disclosed the amounts. However, it is perhaps unsurprising to see that Johnson & Johnson did not donate to the American Red Cross. I guess there’s still some bad blood there. With the tragedy in Haiti, J&J could have worked with the American Red Cross to put that unfortunate period behind them – an opportunity squandered.

Be a Flu Fighter

In the too-weird-to-be-fiction, the Department of Health and Human Services is stepping into high gear by launching a Facebook application called “I’m a Flu Fighter.” The theory is that you’re supposed to tell your friends that you are taking steps to reduce influenza transmission and getting vaccinated. That’s after you’ve picked a cool avatar for yourself.

Given HHS Secretary Kathleen Sebelius complete incompetence when it came to handling the H1N1 outbreak, I guess we can see how she’s been spending her time – Facebook. In typical Sebelius-style, she’s doing a terrific job! As of my writing this, HHS has managed to secure 80 fans. Wow! Really impressive work! One has to wonder how much money HHS spent to get the word out to those 80 people.

In the HHS press release, Secretary Sebelius says: "Friends, family and neighbors can make the difference in whether or not someone gets vaccinated against the flu. Social media has been an important tool to communicate with young people and all Americans about the importance of getting the H1N1 Flu vaccine throughout our vaccination program. This new Facebook application will help friends encourage each other to get the H1N1 flu vaccine."

You know, she’s right. However, social media is something you do AFTER you’ve mastered the basics (like a comprehensive plan for fighting flu and distributing vaccine to Americans in priority groups). So, instead of actually being a Flu Fighter, HHS Secretary Sebelius decided that she was going to pick an avatar for herself and pretend to be a flu fighter. The time for Sebelius to get engaged was months ago – before her agency completely bungled the handling of the H1N1 vaccine distribution.

HHS likes to point to the fact that 1 in 5 Americans received the H1N1 vaccine (that’s 20%) – and the majority of those received the vaccine too late. This is hardly a success story. Here’s the reality of Sebelius’ handling of H1N1: 55 million people contracted the disease with 246,000 requiring prolonged hospitalization and 11,160 dying of the disease. I hate to be critical here, but this is an absolute public health embarrassment. The Government, under Sebelius' leadership, did far too little, far too late.

America needs an HHS Secretary that can do more than play house. Perhaps she could try something novel – actually being the Secretary of HHS. I know I’m asking a lot of her, but I think Americans deserve more than the Scarecrow Governor from Kansas who goes to Washington.

Skyrocketing Prescription Prices?

The General Account Office issued a report with sensational headlines announcing “extraordinary price increases” for pharmaceuticals. Like most of the government pricing reports, the GAO looked at brand name drugs and ignored actual utilization, including the fact that many of those drugs have generic competition. The report looked back nearly a decade and found major price increases – particularly on new drugs just coming to market. Kudos to the GAO for studying the obvious and driving to meaningless conclusions.

Rather than looking at brand name only drugs, it’s important to look at the drugs in the context of how they’re actually prescribed. This would include looking at how over 60% of the drugs dispensed in the U.S. are generics – at a significantly lower price point.

Sadly, government reports love to pick on the drug industry, but don’t look at other aspects of the healthcare system. If drug prices are going up so alarmingly, then why is the percentage of pharmaceuticals still only 10% of the overall healthcare expense? If drug prices are skyrocketing, then the same must also be true of physician fees, lab tests, malpractice insurance and everything else that makes up the healthcare industry. You can’t change the numerator and keep the denominator constant and still end up with the same percentage.

In fairness, the GAO did fess up that most of the products they studied cost less than $25 per unit. The GAO also acknowledged that in more than half of the cases they looked at, the price increases were not drug companies charging more, instead, it was distributors increasing prices.

What is clear from this report and the way the conclusions were framed, is that the results were completely political.

Government Says Healthcare Reform Will Cost More

A new report issued by the Obama Administration casts doubt on the Administration’s own claims. The new report from the Centers for Medicare & Medicaid Services (CMS) says that the health reform bill working its way through Congress will cost Americans more than the Government is claiming and millions of Americans will lose their employer coverage.

Worst of all, the healthcare reform bill currently pending in Congress would force many physicians, particularly those in rural areas, out of business entirely, or force them to stop seeing patients with Medicare. So, while more Americans will be “covered,” they will find it incredibly difficult to find a doctor that is going to accept them. This really shouldn’t be a news flash to anyone. Those of us old enough to Medicare have been experiencing this problem for many years as our physicians have decided they will no longer accept the Government-run insurance plan.

Instead of looking ways to truly reform healthcare (and tackle the real problems of medical malpractice and tort reform), we’re on the verge of enacting meaningless “healthcare reform” that will increase profits for trial lawyers, provide more Americans with coverage they can’t actually use and saddle future generations with trillions of dollars in debt.

FDA Approves RA Drug

More than a year after asking for additional data, the FDA approved Actemra for the treatment of moderate-to-severe rheumatoid arthritis. Actemra is the great hope in Roche’s portfolio and a major driver in Roche’s total acquisition of Genentech.

Roche has every reason to be optimistic. Actemra enters an already crowded market with Johnson & Johnson’s Remicade and Abbott’s Humira have been firmly entrenched for many years and inhibit tumor necrosis favor (TNF). In 2009, J&J received approval Simponi, which is also a TNF inhibitor. However, Actemra, which uses a different mechanism of action and targets IL-6, is approved to treat patients that have failed these existing therapies.

Watch for Actemra to achieve blockbuster status.

2009 FDA Drug Approvals

The results are out and pharmaceutical innovation inched up in 2009. The FDA approved 26 compounds, including 7 biotech therapies. This was up from 25 drugs, and 4 biotech therapies in 2008.

Much has been made in the popular press about the innovation draught. But there is clearly a backlog of compounds awaiting review at review at the FDA (nobody knows this more painfully than the generic drug manufacturers). At the FDA, it’s gotten to the point that PDUFA now stands for Particularly Dreadful, Under-Funded Agency. Off the top of my head, I can’t think of a single drug in 2009 where the agency met the PDUFA deadline. I’m sure there’s a positive example somewhere, I can’t think of it.

Reference: Fierce Biotech

Security of Patient Privacy

This is interesting. The U.S. Department of Health and Human Services is looking for a contractor to test privacy rule under the Health Information Portability and Accountability Act (HIPAA). More specifically, the contractor will be tasked to look at de-identified patient data sets and determine if re-identification is possible.

Re-identification has not only been theorized by patient privacy advocates, but they remain convinced that it routinely happens in grassy knoll-inspired conspiracy theories. Deborah Peel and the folks over at the Patient Privacy Rights group have long used scare tactics to convince Americans that access to all of their health records was almost as easy as looking them up in a phone book. The privacy community loves to use use analogies that de-identified data is a “house built on shifting sand,” “a levee about break,” or even the 9/11 inspired “jetliner heading straight at the building you’re in” - all brilliantly vivid and totally designed to scare ignorant people.

Health systems, information brokers (such as IMS Health or SDI Health) and even the federal government all maintain de-identified information sources for health research purposes. The data is maintained as de-identified. In fact, there’s no incentive to re-identify – the research interest in is in trends over time, not what I had for breakfast (Yoplait blueberry yogurt and oatmeal – at my age, I need all the fiber I can get).

I’ve long said, the real issue here isn’t patient privacy at all. It’s money. The head of a patient privacy rights organization sat on an advisory board to a company developing personal health records. All was well, until large financial “donations” were demanded. In other words, the company was being told, we’ll come out against you unless you give us money. Back in my day, we called that a shakedown. Such is the real issue with these patient privacy rights groups. There’s an organization that issues a report card on the privacy of personal health record vendors that, you guessed it, matches up nicely to donors who contribute money (fair disclosure: this organization refuses to update their financial disclosures since 2007 – my guess is they are hiding something).

I wish HHS luck in their quest. Frankly, I look for anything that falls under HHS Secretary Kathleen Sebelius to sink like the Titantic. However, maybe she’s learned her lesson. Good luck to whoever HHS taps for this Don Quixote mission.

Ref: Washington Technology