2009 Year in Review; A Look at 2010

Every year, I compile my top stories of the year and offer some predictions on where I think we're going. Last year, I set off a storm as I waded into preemption and in 2007 I called the growing focus on "sunshine laws" - those troubling relationships between doctors.

So, what happened in 2009 and what does it hold for 2010?

The War on Patients
The battle for and against healthcare screening has become nothing short of a war on patient's health. 2009 saw rationing, restrictions and "guidelines" designed to restrict access and increase the mortality of disease across a range of disease: colorectal cancer (CMS torpedoed virtual colonoscopies), breast cancer screenings in which women were cautioned to be screened much less frequently and allow their tumors to progress (courtesy of the USPSTF), the ongoing battle for healthcare parity for XY humans (recommendations against PSA prostate cancer screening for me) and recommendations screening for cervical cancer. Given the government's desire to claim victory in healthcare reform (while not enacting any actual major reforms), I'd look for the war on patients to escalate significantly in 2010 - and move beyond cancers into other diseases.

Hype and Hesitation over H1N1
H1N1. Swine flu. Words barely in anyone's vocabulary at the beginning of the year have become completely mainstream thanks to media hype and sensationalism not seen since Monica's blue dress. But within the hype was the real story - a near complete meltdown within the CDC to manage the outbreak. The CDC received top marks for public education and ongoing communications; however, the agency completely bungled the H1N1 vaccine distribution. Even now, in some states (Pennsylvania) the vaccine is almost completely unavailable even for high-risk groups.

Drug Resistance
In 2009, it seems like nearly every disease was becoming resistant to the drugs used to treat it. It was reported that H1N1 was resistant to Tamiflu and the regular flu was showing some resistance. In Africa, a new and highly dangerous strain of HIV emerged that is resistant to just about everything - even in cocktail form (prediction for 2010: just wait for this to start hitting major cities in the Western world). And antibiotic resistance for MRSA and other pathogens reached record levels.

(Lack of) Real Healthcare Reform
With all of the real stories in healthcare out there, the gorilla in the room is still the (lack of) real healthcare reform. Sure, Congress will push through a deficit-exploding multi-trillion package to expand access for the uninsured, raise taxes on the insured and restrict care for everyone. But this isn't healthcare REFORM. It's political gift wrapping - handouts to trial lawyers and others who bankrolled Obama's victory. Real healthcare reform takes time (not months) and incredible political will to tackle tough issues (that seems to be lacking in the Harry Reid Healthcare Reform Legislation). Instead of looking at how we could truly change the system, we got a potential bill that looks to prop-up inefficiencies will exploding costs. Sure, it will win politicians (both Democrats and Republicans) cheap points from their respective camps, but it won't do anything to actually fix the system. In 2010, I'd look for Harry Reid's health finance reform to pass - and I'd look for the first cracks in the facade to start appearing by December 2010 as Americans find out the truth of what they really got handed.

Looking forward to next year, here are a few other things I'm looking at:

Provenge D-Day
May 1, 2010 - The PDUFA date for Dendreon's Provenge. This story has dragged out for years. I still don't think the FDA will own up and admit to the Agency's mistakes. Approval for Provenge should have happened years ago, but in the new environment of cost-cutting/care-rationing and the embarrassment to the FDA, I look for Provenge not to be approved.

Up in Smoke
Anti-smoking advocate Dr. Thomas Frieden seems to have completely backed off on smoking prevention since he got his political appointment from the Smoker in Chief Brack Obama. Under Dr. Frieden's leadership, we saw the first increase in smoking rates in decades. I'm looking for that trend to continue in 2010.

Medicare Fraud
Healthcare reform will have two clear winners: doctors and trial lawyers. Given the massive sums of money involved, I would look for Medicare Fraud to top $250 billion next year. That's right - a quarter of a trillion dollars in Fraud - fraud that CMS doesn't seem all that anxious in stopping and the White House would prefer to ignore. It would seem to me one way to help pay for real healthcare reform would be to aggressively tackle fraud, but the Obama administration sees it otherwise.

2009 was a wild year, but 2010 will be even wilder.

San Antonio Breast

It’s been an interesting weekend at the annual San Antonio Breast Cancer Symposium sponsored by the American Association for Cancer Research. The weather has been pretty good this year, thankfully it is warmer than it is back home.

Of course, the USPSTF opposition to breast cancer screening is generating a lot of informal chatter among participants, which is to be expected. The breast cancer survivors, many of them diagnosed under the age of 50, are absolutely belligerent at the idea that government is playing politics with their health.

In San Antonio, there are two major stories that I’m following. In the first, Onyx Pharmaceuticals and Bayer’s Nexavar (sorafenib) was able to resensitize hormone-sensitive breast cancers and boost the treatment with aromatase inhibitors. Since Nexavar is approved for kidney and liver cancer, this opens a new avenue for Onyx to pursue and a large trial is in the works. The addition of Nexavar allowed the aromatase inhibitors (including, AstraZeneca’s Arimidex and Pfizer’s Aromasin) to continue working and shrink tumors.

The other story I’m following at San Antonio Breast – combining Genentech’s Herceptin and GlaxoSmithKline’s Tykerb, which extends survival in women by five months vs. women who received just Tykerb. This is in women with very advanced stage breast cancer, so the benefits in early-stage tumors are likely to be more pronounced.

Of course, the problem with these pharmacological therapies is the dependency on coverage and reimbursement. Is five months of survival worth the extra money? I’d say yes, but given the recent actions of the government in rationing breast cancer diagnosis and treatment options, I’m rather pessimistic.

Congress Takes Up Doctor Data

The issue of privacy and accountability got a lot murkier last week when Senators Herb Kohl (D-WI) and Dick Durbin (D-IL) introduced an amendment on the Senate health reform bill that would block the sale and utilization of physicians’ prescribing information. This has been a hot topic on the state level for several years with various States (New Hampshire, Vermont and Maine) passing similar bills and various legal challenges. The Supreme Court has declined to weigh in, opening the door for this potential federal law.

The laws would pertain only to the sale and use of this information for “marketing purposes.” However, as we’ve seen in various Federal Court testimony, it is assumed that the only possible way the pharmaceutical companies could use this data is in “marketing,” so this is essentially eliminating this data stream. In the case of New Hampshire, the physicians arguing in favor of these bans have other motivations.

The doctors lobbying the hardest for this legislation are also the ones with the most to hide – physicians who have been investigated for Medicare fraud and doctors who help patients obtain opioid pain medications. These doctors are the silent and sometimes not so silent partners in doctor shopping behavior. Destroying the data stream for pharmaceutical marketing purposes will make it more difficult for the DEA and other law enforcement agencies to track criminal behavior. For the doctors in New England who have pushed this initiative, this is the ultimate motivation. This is one of the primary reasons why New Hampshire has one of the highest rates of prescription drug abuse in America (see New Hampshire Prescription Drug Abuse).

I believe that this legislation is inevitable. The motivation of the AMA-backed doctor lobby is too strong. As physicians find their revenue streams curtailed through healthcare reform in Washington, D.C., many doctors will continue to supplement their incomes in other (and less legal) ways – notably selling prescriptions for opioid pain medications.

There is another possible implication for this. A few weeks ago, IMS announced that it would be selling itself to private equity firms for $22 a share, or $5.2 billion. IMS is one of several market research firms that provide this kind of information. If this Congressional legislation goes through, it will be interesting to see if the IMS deal goes through.

Ref: Wall Street Journal Health Blog
Ref: Bloomberg
Ref: IMS Statement

H1N1 Death Toll Tops 10,000 in U.S.

CDC officials have acknowledged that the H1N1 death toll has exceeded 10,000 since April, well after the alarms were sounded. More than 200,000 Americans have been hospitalized and 15% of the American population has been sickened with the swine flu.

Availability of the H1N1 vaccine continues to be a nationwide crisis. Earlier today, CDC head Dr. Thomas Frieden told reporters that the vaccine is now more generally available to the point that they are opening up access to the general populous. I have to wonder what planet Dr. Frieden is living on (or what recreational drugs he’s indulging in). In some parts of the country, there are still waiting lists for priority groups (such as children and healthcare providers), much less making the vaccine available to general public.

Despite his personal promise to become actively engaged in the H1N1 vaccine crisis, President Barack Obama has largely ignored the massive supply problems of the vaccine. The recent OpEd on MSNBC really hit the nail on the head – calling the White House’s flu response “dismal at best.” The article states, “The Obama administration bears much of the blame for the fear the public and health care workers have of the swine flu vaccine.”

While President Barack Obama has finally declared a state of emergency, he hasn't gone beyond that. Many critical months were lost when his Administration could have responded, but didn't. Clearly, Obama’s trust in HHS Secretary Kathleen Sebelius was misplaced at best. It’s a pity that President Obama hasn’t addressed this crisis and investigated the failings of his Administration to adequately distribute the limited vaccine supplies.

Ref: Reuters
Ref: H1N1 Death Toll Soars

AZ’s Seroquel XR Gets MDD Indication

AstraZeneca received FDA approval for Seroquel XR for adjunctive treatment of Major Depressive Disorder (MDD) on Friday. The announcement is an acknowledgement of how many physicians have been using the drug off-label for some time.

This won’t have major implications for product sales, but does help AZ in promoting the product in a heavily congested class.

Lilly’s Zyprexa Gets Additional Indications

The FDA gave Eli Lilly approval for Zyprexa (olanzapine) to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old. The drug offers a new opportunity for physicians in younger patients that did not respond to other pharmaceutical therapies. The approval followed a positive recommendation from an FDA advisory panel in June.

Zyprexa joins BMS’s Abilify and J&J’s Risperdal, which already have approval for pediatric use.

Zyprexa is a certified blockbuster with global sales of $4.7 billion in 2008, providing over 23% of Lilly’s revenues. Americans spent over $14.6 billion on antipsychotics in 2008 – making it the best selling type of medication in the U.S.

Reference: Eli Lilly

Pharmas Developing New Drugs for HIV/AIDS

A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that drug companies have 97 compounds and vaccines in development for the treatment of HIV and AIDS. Drug companies have 54 antiviral compounds and 23 vaccines in research – either in clinical trials or awaiting approval by the FDA.

Pharmaceutical companies have already developed 31 medicines to treat HIV and AIDS.

Some good news for World AIDS Day earlier this week.

Ref: PhRMA Press Release