New Hampshire Data Ban Struck Down

A New Hampshire law that restricted the collection and sale of information that would identify physicians was struck down by a federal judge for being unconstitutional. The judge ruled that the law was a restriction on free speech. [Press release from IMS Health and Verispan.]

This has been an interesting story up in the northeast, which I have recently discussed. New Hampshire, a state that is fiercely independent and anti-big government, became the first state in the nation to enact physician privacy/secrecy legislation. It seems that this wasn’t really a law to protect physicians as much as it was a piece of special interest legislation introduced by a New Hampshire Representative on behalf of her husband, a cardiologist in NH. This law is just a manifestation of the physician paternalism I’ve previously discussed.

Now, according to this state representative and her husband’s friends, the stated objective of the law was to rein in the State of New Hampshire’s spending on prescription drugs in the Medicaid program. Unfortunately, the representative and her husband’s friends were not able to offer any specifics on how this law would decrease drug costs (as previously discussed)

Just a guess, but I imagine that The State of New Hampshire will probably try and appeal the decision. If I were a resident of the State of New Hampshire, having already lost one costly legal battle over a flawed law, I’d have to wonder what the State will gain by pursuing an appeal (other than blowing a bunch of the State’s money).

Thanks to Mike Porter for the tip. Photo courtesy of Pharmalot.

Pfizer Wins Approval for Celsentri

Last week, an FDA advisory committee unanimously voted to recommend Pfizer’s Celsentri (maraviroc) for approval. The drug is the first in a new class of drugs targeting the CCR5 receptor.

The drug holds great promise for patients with HIV, but the same may not be true for Pfizer. Cost and access will be a significant issue for patients and Pfizer is likely to face significant patient activism.

Pfizer’s not out of the woods yet.

NLARx – Back from the Dead

The group of about six state legislators that calls itself the National Legislative Association on Prescription Drug Prices (NLARx) has not gone out of business (contrary to my previous posting). It would appear that the group just forgot to pay the bill on the old NLARx.org website domain. With NLARx.org gone, they are transitioning over to their new operational headquarters at NLARx.com (as noted in a recent Associated Press story).

The old domain, NLARx.org, spent the last few months hawking virility pills. I guess they are encouraging men to stay harder, longer. In all seriousness, this is a group of state legislators that claims to be solving the problems of high drug prices. How can we take fiscal advice from a group that can’t even pay the website bill?

The Week Ahead – April 30-May 6

April 30 – Health and Human Services Department (HHS); Food and Drug Administration (FDA) are holding a Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, Manufacturing Subcommittee, to discuss issues pertaining to the stability of tablets split for patient use; receive a general update and discuss current strategies on quality by design and the Office of Generic Drugs' question-based review; and receive an update on and discuss the status of the Office of New Drug Quality Assessment Chemistry, Manufacturing, and Controls Pilot Program.

May 1 – Food and Drug Administration and HHS is holding a Pulmonary-Allergy Drugs Advisory Committee to provide advice and recommendations to the agency on FDA's regulatory issues.

May 2 – Senate Finance Committee is having a Medicare Prescription Drug Benefit full committee hearing entitled "The Medicare Prescription Drug Benefit: Monitoring Early Experiences." Witnesses include Kris Gross, director of the Senior Health Insurance Information Program in the Iowa Insurance Division; Vicki Gottlich, senior policy attorney for the Center for Medicare Advocacy, Inc.; Tobey Schule of Sykes Pharmacy, Kalispell, Mont.; and Timothy Tucker, president-elect of the American Pharmacists Assn.

May 2 – House Energy and Commerce Committee is having a Biosimilar Medicines Policy Health Subcommittee hearing on "Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States."

May 3 – Healthcare Businesswomen’s Association is having their 18th Annual HBA Woman of the Year luncheon in New York. The Healthcare Businesswomen’s Association (HBA) has named Meryl Zausner, Vice President and Chief Financial Officer, Novartis Oncology, as the 2007 “Woman of the Year.”

May 6-9 – BIO International Convention at the Boston Convention & Exhibition Center.

Arcoxia Flushed

It's official sports fans - FDA rejects Arcoxia.

And exactly no one is surprised.

40 Years of Pharma

And we’ve come a long way baby!

In 1968, the country was still recovering from the Summer of Love. There were really two countries—one desperately clutching to the 1950s and one rocketing into the modern era.

The pharmaceutical industry mirrored the country as a whole. Medicine was in a wholly different place. Sales reps detailed doctors with almost no accountability. Reps didn’t have access to physician prescribing information, so they made friends with pharmacists to try and figure it out while detailing every doctor in a geography—a waste of both the doctors and reps time.

One of the most popular products in the bag of nearly every rep was amphetamine tablets—essentially speed. That’s right. Before 1971, amphetamines were prescription products that were sampled by reps (classified Schedule III). Amphetamine was routinely prescribed for pregnant women in the 3rd trimester to elevate the mood (and oh boy, did it ever elevate the mood) and also to curb the appetite to prevent too much weight gain. The amazing thing is that amphetamine crosses the placental barrier, so do the analysis on that situation. And before 1968, there were no chain-of-custody requirements or physician signature requirements on amphetamine samples. There was nothing to stop reps from using them discretely or sharing/selling them. And it happened.

Not to be outdone, many physicians did a booming “side business” in giving/selling amphetamine “happy pills.” The physicians were so desperate to replenish their stashes they often called the reps to ask for more. The amphetamine side business was a cash business, not likely to be reported on a doctor’s income tax return.

Physicians had no ethical concerns about directly asking for bribes and gifts. This included cash, trips, meals, new tires for their car, gifts for their kids, etc. In the very early days, the drug companies would not oblige, but reps would do so out of their own pockets to further the relationship. Doctors would play reps off each other for the most lucrative handouts. In the early days, these requests were initiated by the doctor, and not offered by the rep.

In the last few days, much has been made of the physician-rep interaction. I wanted to take this stroll down memory lane to make two points:

1. Whatever perceived improprieties (be they real or fabricated) may exist today, it has improved significantly.
2. Any discussion of rep behavior must also discuss the corresponding physician behavior.
   

Old timers in the industry can attest to the changes we’ve seen. So yes, we’ve come a long way baby!

Physician Paternalists Bring Out Big Guns

The New England Journal of Medicine published a study today examining physician relationships with drug companies. According to the study authors, more needs to be done to address their concerns about physician-industry relationships.

I’m sorry. I’m so tired of the paternalists saying that doctors are manipulated by drug reps because they bring pens and salads. If these relationships are so detrimental, why don’t doctors stop seeing reps? More importantly, what evidence do the paternalists have that these inactions are bad? (Hint: This study does not provide any evidence to support those assertions.)

Just like the PLoS study by Adriane Fugh-Berman and Shahram Ahari which was underwritten by trial lawyers through their paid-for testimony in court cases, this study is also suspect. Study authors Eric Campbell and David Blumenthal of the Institute for Health Policy at the Massachusetts General Hospital and Harvard Medical School both have strong and compelling anti-industry ties. The Institute for Health Policy does not disclose its sources of funding on its website.

David Blumenthal epitomizes the physician paternalists. He argues doctors are so corrupt and deluded that they need every aspect of their professional lives to be regulated by the government. He states, “We have given physicians a lot of freedom to govern themselves and to voluntarily follow guidelines set by the profession. If they are unable to monitor and manage these practices, there will be increasing pressure on government to do it for them.” Brilliant.

And what compelling evidence has led Blumenthal to the radical position of a government-sanctioned crackdown on doctors? It is this: 94 percent of doctors report that they have had one interaction with the pharmaceutical industry (be it lunch or free samples to help their poor patients).

The only conclusion that can reasonably be drawn by this study is that nearly all doctors have had some interaction with the pharmaceutical industry. And that’s it and nothing more. There is nothing in this study to suggest that those interactions exert undue influence or harm patients. In fact, quite the opposite appears to be true from other studies—the physicians who do interact with reps receive samples that benefit poorer patients.

Disgruntled Rep Strikes Back

And it’s not Jamie Reidy.

The open-access journal Public Library of Science (PLoS Medicine) pushed an article this week that was written by Adriane Fugh-Berman, Georgetown University Medical Center researcher, and former Eli Lilly rep Shahram Ahari.

Their “study,” whose methodology is so weak that it could only be published in this open-access forum, contends that drug representatives have a huge impact on physician’s prescriber behavior. In the article, they contend that being nice to doctors is so compelling that doctors just swoon whenever a rep walks in the door. Making small talk about the doctor’s lives is so dramatic that it creates undue influence.

Don’t bother looking up the article (although the reference is below in the interest in fair disclosure). There’s no real substance here, just a string of non-related facts and quotes about the pharmaceutical industry intended to advance Shahram Ahari’s opinion (though they just say “SA” in the article to make it seem more legitimate than just one former sales rep-turned-paid-legal-witness). [Speaking of which, anyone got any copies of Ahari’s legal testimony?] The PLoS journal article notes that much of Shahram Ahari’s contribution (and Adriane Fugh-Berman for that matter) was funded by trial lawyers in their work as paid-for “experts” in court cases…hardly unbiased.

Here’s the journal article:
Citation: Fugh-Berman A, Ahari S (2007) Following the Script: How Drug Reps Make Friends and Influence Doctors. PLoS Med 4(4): e150 doi:10.1371/journal.pmed.0040150

[Note: Stay turned late in the day as the physician paternalists will be breaking big "news"…]

Senator Stabenow Takes Aim at Market Exclusivity

Back on April 11, Senator Stabenow (D-MI) has introduced the Lower Priced Drugs Act (S. 1088) which would cut market exclusivity for certain drugs. The bill has been referred to the Senate Health, Education, Labor and Pensions (HELP) Committee.

Introduction of the bill comes on the heels of Stabenow’s junket to a swanky Arizona golf resort and spa with generic industry insiders (see Biosimilars Heat Up in Washington). It looks like the Generic Pharmaceutical Association's (GPhA) efforts at legislative relationship building are really paying off.

AstraZeneca buys MedImmune, huh?

AstraZeneca plopped down $15.2 billion this morning to purchase MedImmune. And for its $15 billion, AstraZeneca gets…not much—a second-generation Synagis, Numax and refrigerated FluMist. And that’s about it.

As part of the deal, MedImmune will bring its experience with biologics, hopefully goosing AstraZeneca’s lagging R&D initiatives. AZ does get access and influence in an area where they haven’t been able to successfully play before, including MedImmune’s 400 specialty sales reps. But that’s an awfully tall order for $15 billion.

When I first heard rumors of this proposed merger in February, I had to say, “huh?” My reaction is pretty much unchanged. MedImmune has been plagued by management issues and an all-consuming need to sell itself. AstraZeneca took the hook. Unfortunately, AZ doesn’t exactly have a strong reputation when it comes to integrating on mergers and acquisitions.

The Week Ahead – April 23-29

April 23—The Center for Health Transformation is holding a briefing on "Personal Health Records: Connecting Consumers, Transforming Health." Among the participants is Former House Speaker Newt Gingrich (R-GA), founder of the Center for Health Transformation; Scott Serota, president and CEO of Blue Cross and Blue Shield Assn.

April 23-24—The National Minority Health Month Foundation hosts the “4th Annual National Summit on Health Disparities, "Improving the Quality of Care.” Being held at the Ritz Carlton Washington, D.C. in Washington, D.C. Members of congress, distinguished honorees, and renowned clinical experts discuss solutions that may help to reduce the healthcare quality gap that exists with minorities.

April 24—The American Enterprise Institute for Public Policy Research is presenting "Medicare's Fiscal Future: Getting Worse? Getting Better?" This is the first part of a health policy double feature to be held at AEI on April 24. Following the Medicare panel, secretary of the Department of Health and Human Services Michael Leavitt will deliver a major policy address on promoting health insurance. Address and dialogue with Health and Human Services Secretary Michael Leavitt in an event titled: "Promoting Health Insurance for Children and All Americans," focusing on the State Children's Health Insurance Program that (SCHIP) pays a part of the cost of insurance coverage for millions of low-income children who are not eligible for Medicaid. SCHIP is a focus for expansion by the Democratic leadership on Capitol Hill.

April 24—The Food and Drug Administration is hosting an Antiviral Drugs Advisory Committee to discuss new drug application proposed for the treatment of antiretroviral-experienced patients with tropic HIV. The committee will discuss new drug application (NDA) Pfizer, Inc., proposed for the treatment of antiretroviral-experienced patients with chemokine receptor 5-tropic human immunodeficiency virus (HIV).

April 25—Food and Drug Administration is holding a forum to provide information to small pharmaceutical businesses about FDA's premarket requirements, good manufacturing practices, and over-the-counter and generic drug issues.

April 25—House Energy and Commerce Committee is holding a Health Insurance Coverage meeting. Health Subcommittee hearing on "Living Without Health Insurance: Why Every American Needs Coverage."

April 26-27—Harvard University Program in Ethics and Health is holding a Conference, "Responsibility for Health Ethical Issues," at Harvard Medical School. This conference seeks to clarify the issues at stake in debates over responsibility for health and to enlist the methods and theories from a number of disciplines in forging a coherent social response to the issues. The first day of the conference is primarily theoretical; the second is devoted to law and policy responses.

April 27—The Food and Drug Administration (FDA) is announcing a public hearing to solicit views and information from interested parties concerning the concept of electronic distribution of FDA-approved prescribing information currently contained in the package insert (or PIs) for human prescription drug and biological products. In particular, FDA is seeking views and information on the feasibility of establishing a modern and efficient process for industry to electronically distribute prescribing information to dispensers.

Pfizer Disappoints

It’s a bad day on East 42nd Street.

Pfizer first quarter earnings fell (and fell) on special charges, anemic sales of Exubera and increased generic competition for Norvasc and Lipitor. In first quarter 2007, Pfizer earning $3.39 billion compared to $4.11 billion last year ($0.48 vs. $0.56 on a per share basis). And that was the good news.

The bad news is that Pfizer is looking at about 6 more quarters of this before anything might get better. They are still in the midst of cutting over 10,000 jobs by 2008.

To be fair to Pfizer, they were able to grow top-line revenue by about 6% in the quarter. The company’s animal health unit did well in 2006 and has some new products on the horizon (see Animal Health Boosts Pharma?). The Lipitor patent seems to be holding strong (see A Mixed Week for Pfizer and A Good Day for Lipitor). Finally, Pfizer won a key challenge on three patents for Celebrex.

Kaiser Finds Medicare Being Bilked Billions

The researchers over the Kaiser Foundation ran an announcement in their Daily Health Policy yesterday under the headline, “Medicare Fraud Costs Billions of Dollars Each Year, CMS Officials Testify.” Medicare fraud is nothing new and I’ve discussed this before in The Truth of Medicare Spending.

According to the report, CMS Administrator Leslie Norwalk testified this week at the House Energy and Commerce Subcommittee on Health hearing that Medicare fraud costs the government billions. She said, “The fraudulent business practices of unscrupulous durable medical equipment, orthotics, prosthetics and supplies suppliers continue to cost the Medicare program billions of dollars… [CMS] has seen a marked increase in fraud and abuse activities over the past few years that can be directly tied to provider enrollment issues.” Norwalk specifically noted this fraud is perpetuated by corrupt physicians who utilize high-cost medical equipment and then take a kick-back from the device manufacturers.

In Florida, The HHS Office of Inspector General found in a recent analysis that about 20% of medical equipment and providers were fraudulently billing the government and stripped them of their Medicare eligibility. This was just one county in Florida and represents the tip of the iceberg nationwide.

When I first heard about this report, I was skeptical, fearing that it was another Kaiser Family Foundation report, subject to all of the normal assumptions, biases and errors that come along with their research. However, given this is based on HHS and CMS testimony to Congress, this is probably quite reputable. You can read the Kaiser Daily Health Policy Report here.

Unfortunate Events Result in Comment Moderation

It is with regret that I must now moderate comments. I knew that my previous posting Anti-Science Propaganda would result in criticism from the anti-scientist crowd. I mistakenly believed that an intellectual exchange of ideas was possible with these individuals. However, someone decided that it would be appropriate to post racist hate speech in the comments. I would like to extend my apologies to anyone who has been offended by their inappropriate comments.

I am disappointed with the anti-scientists—the parental activists and the Scientologists. Frankly, I expected mature behavior and their ability to respond with thoughtful ideas of their own, perhaps even some facts. Instead, they could only offer yelling (typing in caps) and racist hate speech. If they ever get their Congressional Inquiry, I would hope they could do better (but I’m not holding my breath).

My comment policy is this—I believe in the intellectual exchange of ideas and am willing to post all thoughtful comments to my blog, including contrarian views.

Anti-Science Propaganda

All the news about Cho Seung-Hui and the potential that he may (or may not) have been taking antidepressants has fanned the flames of the anti-science crowd.

This discussion reminded me about the first time I ever heard about the belief that SSRI’s were the cause of violent (including suicidal) behaviors. I was taking a flight from Las Vegas to Newark almost a decade ago and sat next to a very “unique” woman. Somewhere near the Mississippi River, just after telling me about her brother’s “alien encounter” and her sister living in a pluralistic marriage in Nevada as wife #3, she told me about the evils of antidepressants. It was a surreal experience one doesn’t forget.

The anti-science crowd is gathering all its resources on this one. They have been arguing that individuals are perfectly normal, although a little sad, until prescribed antidepressants and then became crazy killers (i.e., it was the drugs fault). This whole issue goes to causality. An individual can be taking antidepressants and commit terrible crimes. They can be taking Lipitor and commit terrible crimes. Or they could eat a Twinkie and commit terrible crimes. Did the drug (or Twinkie) cause the crimes? The anti-science crowd offers anecdotes, logical fallacies and voodoo, hoping the public will bite on sensational stories.

Their movement is fed by trial lawyers, who often underwrite the anti-science crowd financially. [Note: The anti-scientists have also closely aligned themselves to the Church of Scientology through a front group called the Citizens Commission on Human Rights. Oops, here comes the Guardian Office…] They feed into these people’s insecurities, offering them abdication of responsibility and the hope of huge financial payoffs. In a comment posted yesterday on a blog, one of these parents indicated that her daughter was mis-diagnosed with depression. She faults the drug’s manufacturer, not the doctor who botched the diagnosis and wants lots of money from the pharma company. You see, the drug companies provide a more lucrative financial target.

As evidence for their opinions, they offer up a collection of newspaper articles from the last decade of 1,572 individuals that took antidepressants and then committed crimes. Again, they can’t prove causality here. In a back-of-the-envelope calculation using the anti-science crowd’s own numbers, it comes down to 0.0022% of people taking antidepressants commit crimes. To put this into perspective, this is half the violent crime rate in most cities (Philadelphia is 4.2 per 1000 or 0.0042%; Raritan, NJ is 0.0082%; Paducah, KY is 0.0089%).

Having angered the anti-scientists, here are some of the comments they posted in response on another blog yesterday:

• “there is ABSOLUTELY NO SCIENTIFIC EVEIDENCE TO BACK UP A SINGLE PSYCHIATRIC "DISEASE".”
• “drugs don't work in most people. What they do is make people sicker. I saw my father in law and my grandmother both die earlier than they should because of drugs. WAKE UP AMERICA.”
• “WE, the so called "anti-med" crowd are not anti med..we are pro heal”

In 14 comment posts, not a single scientific fact was offered (although there was a lot of hyper-emotional typing in all caps).

As evidence, the anti-science crowd says you only need to look at the adverse events in the products labeling in the PDR or Drugs.com. So, let’s do that. I will be the first to admit that in clinical trials, SSRIs and other antidepressants are associated with sweating, sleep disorder, nausea, decreased appetite, ejaculatory disturbance, decreased sexual desire, dizziness, insomnia, tremors/shakes, constipation, nervousness, agitation and anxiety. For good measure, we should throw in the ubiquitous dry mouth, headache and muscle aches. I will also be the first to admit that if you look at clinical studies on people with diagnosed mood disorders not currently taking medication, you will find the following symptoms: sleep disorders, increased or decreased appetite, decreased sexual desire, insomnia, agitation and anxiety. So, I have asked the question—chicken or egg? Do these patients have these symptoms, go on antidepressants and continue to have symptoms (science seems to say yes)? Or is what the anti-scientists contend—that these patients are 100% normal, are forced to take these medications, become “involuntarily intoxicated” (using their terminology), and then go on crazy rampages killing people?

As a solution, the anti-scientists think a Congressional Inquiry is necessary. Why, you might ask? They have been unsuccessful in advancing their social/religious agendas through the regulatory process and, more importantly, through the rigors of peer-reviewed science. Years ago when they began trying to prove causality through anecdote, the science was mixed. However, recent studies (including a government-funded study earlier this week in the Journal of the American Medical Association which looked at 27 major clinical trials in 4,400 children) have demonstrated that “antidepressants benefits exceed risks.” These scientific results have not rested well with the anti-science crowd.

By all means, let’s have an investigation…a scientific one. Not Tom Cruise jumping on Oprah’s couch or Church of Scientology testimonials from Xenu and their aliens…we’re talking real science. That means blinded, controlled clinical trials. Let’s make them unbiased (not funded by any pharmaceutical manufacturer or the Church of Scientology).

If I’m wrong, then I’m wrong. But the discussion should be informed by science, not myth and anecdote. I’ll take science over aliens and polygamy any day.

AARP Boosts Bottom Line with Medicare Advantage Plans

Bloomberg has reported that the American Association of Retired Persons (now d.b.a. as AARP) has struck deals with Aetna and UnitedHealth for new insurance plans. AARP’s revenue from insurance will jump about 50% next year (from about $409 million this year) to about $628 million next year. No word on when AARP will launch its new tagline: The Power to Make More Money!

As part of the deal, UnitedHealth will run the first AARP-branded and endorsed Medicare Advantage insurance plan. These Medicare Advantage plans are really cash cows and AARP is looking to capitalize on government overpayments to MA plans (recent media stories have noted that Medicare Advantage plans receive 12% more from the government than traditional plans).

According to Bloomberg, “AARP says it’s backing a Medicare Advantage program while continuing to oppose what it recently called ‘inflated payments’ to privately run plans.” In other words, AARP opposes overpayments to others, but is more than willing to collect inflated payments itself (AARP calls this a “leadership position”).

This isn’t the first time that AARP has put profits first. AARP’s endorsement of the Medicare Part D benefit landed the organization in a whole lot of criticism along with the organization’s very cozy relationships with insurance companies and others. One of AARP CEO Bill Novelli’s first moves was to bring in big business like Home Depot for sponsorships.

AARP can spin this anyway it wants, but its completely hypocritical to criticize Medicare Advantage plans one week and then announce you are launching your own the next.

Medicare Direct Price Negotiations – A Summary

Recapping the topic du jour, Medicare Direct Price Negotiations—

Pharmalot has a lovely profile of Senator Harry Reid (D-NV) up on his site. (Photo taken from Pharmalot) I wonder what the elders of the Church of Jesus Christ of Latter-Day Saints (LDS) would have to say about it. Are these the ideals of the Mormon church?

While Reid plays partisan politics on Medicare direct negotiations, AARP’s Bill Novelli is throwing a few more punches in support of S. 3, the Medicare Fair Prescription Drug Price Act of 2007. According to AARP CEO Bill Novelli, “The American people need and deserve to know where their Senators stand on this widely supported issue.” The translation: “If you oppose this bill for any reason, AARP will blacklist you as an enemy of America’s seniors.” Too bad Novelli hasn’t told America’s seniors that this bill won’t reduce the price of their prescription drugs.

As I have previously explained, this issue is a whole lot of partisan flag waving. (see Senate Panel Advances Medicare Direct Price Negotiations and Direct Price Negotiations for Medicare? and finally Direct Price Negotiations to Save Billions). After extensive study, even the Congressional Budget Office (CBO) has concluded that lifting the ban on direct price negotiations is not likely to result in any noticeable savings under Medicare.

Cancer-Killing Viruses and Novel Approaches to Cancer Treatment

More good research at the American Association for Cancer Research annual meeting in LA. Oncolytic viruses that could be harnessed in cancer vaccines are receiving attention, including “smart search-and-destroy tumor busters that will leave normal cells alone” (AACR’s words; claims not evaluated by the FDA).

Study—Targeted Release of Oncolytic Measles Virus By Blood Outgrowth Endothelial Cells in situ Inhibits Orthotopic Gliomas (Abstract 4185)

This is interesting scientific study that could help shape the second generation of cancer vaccines. German researchers at the University Children’s Hospital in Ulm have hidden measles virus inside artificially generated blood cells, providing a way to avoid detecting by the immune system.

This early study in mice, demonstrates the possibility that a virus can destroy glioma brain cancer by getting inside the tumor cells and replicating—destroying the cancer from the inside out. The researchers note that this approach has been tested in clinical trials, with only limited effectiveness.

“In an immune-competent patient, the immune system will fight the virus, and most adults are immune against measles since they have been vaccinated against the disease in childhood or have had measles,” said Christian Beltinger, M.D., an associate professor at the University Children’s Hospital in Ulm. “Although cancer patients are immune-compromised by their disease or because of therapy, they still may mount a sufficient attack against vaccine measles virus.”

Study—Δ-9 Tetrahydrocannabinol Inhibits Growth and Metastasis of Lung Cancer (Abstract 4749)

This study will not doubt be mis-represented on websites in no time. So, straight from the source, “The active ingredient in marijuana cuts tumor growth in common lung cancer in half and significantly reduces the ability of the cancer to spread, say researchers at Harvard University who tested the chemical in both lab and mouse studies.”

The compound, Δ-9 tetrahydrocannabinol (THC), inhibits EGF-induced growth and migration in epidermal growth factor receptor (EGFR) expressing non-small cell lung cancer cell lines. Lung cancers that over-express EGFR are usually highly aggressive and resistant to chemotherapy.

“The beauty of this study is that we are showing that a substance of abuse, if used prudently, may offer a new road to therapy against lung cancer,” said Anju Preet, Ph.D., a researcher in the Division of Experimental Medicine, Harvard University.

Aspirin May Reduce Cancer Risk

A crop of studies at AACR today show that reducing inflammation may reduce the risks of cancer. One study found that women who use aspirins frequently developed fewer cancers than women who did use aspirin.

Study—Association of Aspirin and Non-Aspirin NSAIDs with Cancer Incidence and Mortality in a Large Prospective Cohort Study (Abstract 3400)

A study by the Mayo Clinic of women in the Iowa Women’s Health Study found that regular aspirin use reduced cancer incidence and mortality. Interestingly, these benefits were not associated with non-aspirin NSAID drugs that have been the subject of much media attention recently (or, to be more specific, the benefits were not statistically significant with NSAIDs).

The proof was in the numbers, where aspirin dropped the risk of developing cancer by 16% and decreased mortality by 13%. This study was unique because it did not look at a specific cancer, like breast cancer, rather it looked at overall cancer incidence.

“These study results do not mean, however, that women should throw away their NSAIDs or pick up a bottle of aspirin,” says the study’s lead author, Aditya Bardia, M.D., M.P.H. “This is just one study,” he says. “However, it does provide provocative evidence that regular aspirin use may play a role in preventing the most common chronic diseases in western countries, namely cancer and heart disease.”

No Free Lunch Launches Doc Directory (Finally)

The paternalists at No Free Lunch have finally gotten their act together and posted their list of participants. I’ve previously discussed this group in my posting A Question of Influence – Are Doctors Morally Bankrupt. On its website, you can now find an extensive list of physicians who reject any interaction with pharmaceutical companies. According to Pharmalot, the extensive list of doctors numbers about 500. Which, by my math, 500 physicians is roughly 0.05% of the more than one million prescribers in the U.S. I guess this makes it more of an anomaly than a movement.

As I’ve previously mentioned, No Free Lunch is run by the Corporation for Non-Promotion-Based Medicine (which, according to its website, accepts donations, although does not disclose its sources of funding or its IRS 990; the group is not registered with the GuideStar non-profit clearing house). It took several years for them to post this list of physicians. I imagine it will take several more years for them to finally disclose their financial backing.

A New Era for Pharma Blogs

Last week, we entered a new era for pharma blogging. Allegedly, a group of AstraZeneca employees approached former-Pfizer whistleblower turned movie hopeful Peter Rost (and also journalist Ed Silverman) regarding allegations of off-label promotion at AstraZeneca. Much has been made of this, but few (if any) actual specifics have emerged. Substantial skepticism remains. Although Peter Rose promises a major announcement today, nothing has appeared on his website yet (9:00am ET/6:00am PT).

However, AstraZeneca has had to start taking bloggers seriously, a lesson they could have learned from J&J. Other companies would be wise to follow...

The Week Ahead – April 16-22

April 16 – Alliance for Health Reform is presenting a Briefing, "Medicaid 101: A Primer on the Health Insurance Program for Low-Income Americans." Panelists will be Diane Rowland, executive director of the Kaiser Commission on Medicaid and the Uninsured; Trish Riley, director of the Maine Governor's Office of Health Policy and Finance; and Jeffery Crowley of Georgetown University's Health Policy Institute.

April 16-18 – The CDC is presenting a Symposium, "Statistical Methods: Analyzing & Mapping Health Inequities To Impact Policies for Eliminating Disparities" in Atlanta.

April 17 – The Committee on Energy and Commerce is holding a meeting of "Reauthorization of the Prescription Drug User Fee Act (PDUFA)." This one will be lively.

April 17 – CMS is hosting “Physicians, Nurses & Allied Health Professionals Open Door Forum.”

April 18 – The Food and Drug Administration (FDA) is holding a "Cardiovascular and Renal Drugs Advisory Committee" to discuss supplemental new drug application (sNDA), AVALIDE (irbesartan plus hydrochlorothiazide), from Bristol-Myers Squibb.

April 18 – The Senate Health, Education, Labor and Pensions Committee is hosting Prescription Drug User Fees/Pending Nominations. A full committee markup of S.1082, the "Prescription Drug User Fee Amendments of 2007 as amended by the Food and Drug Administration Revitalization Act"; and vote on pending nominations.

April 18 – The Committee on Energy and Commerce is holding a meeting of Medicare Program Efficiency and Integrity is having a Subcommittee on Health hearing.

April 18-20 – The American Cancer Society (ACS) is hosting a conference on "Research and Programs to Eliminate Cancer Disparities" in New Orleans.

April 22-24 – The 4th Annual World Health Care Congress in Washington D.C. at the Washington Convention Center.

Diet and Lifestyle in the Fight Against Cancer

New studies at the American Association for Cancer Research Annual Meeting in Los Angeles show the role of diet and lifestyle in the fight against cancer.

Study—Flavonols and Pancreatic Cancer Risk: The Multiethnic Cohort Study (Abstract 856)

Researchers at the Cancer Research Center of Hawaii studied the diets of over 180,000 residents of California and Hawaii. The results suggest that a diet high in flavonols may reduce pancreatic cancer risk (especially in smokers). Flavonols are found in foods like onions, apples and broccoli.

Consuming large amounts of flavonols reduced the risk of developing pancreatic cancer by 23%. Results were even higher in smokers. So eat those apples!

The National Cancer Institute estimates there will be 37,170 new cases in the U.S. in 2007…and 33.370 deaths, making pancreatic cancer one of the deadliest (with very few patients surviving five years).

Study—Fruit and Vegetable Intake and Head and Neck Cancer in a Large United States Prospective Cohort Study (Abstract 849)

A study from researchers at the National Cancer Institute (NCI) of AARP members demonstrated the value of adding just a single serving of fruit and veggies. Those AARP members who had a single extra serving of fruit and vegetables had a 29% lower risk of head and neck cancers. Head and neck cancers result in 350,000 deaths each year.

“Identifying protective factors for head and neck cancer is particularly important as it has a high mortality rate,” said Neal Freedman, Ph.D., cancer prevention fellow at the National Cancer Institute.

Genetics and Race Play Role in Cancer Disparities

There are a couple of interesting studies on health disparities at the American Association for Cancer Research (AACR) Annual Meeting. According to AACR, “Minority individuals are much more likely to develop and die from cancer than the general U.S. population. Previous research points to lack of health insurance, poverty, language and cultural barriers, and inadequate access to early detection services and good medical care as causes.” Yet these new studies at AACR point to genetics as a important cause for the “disparity of cancer incidence and mortality between African-Americans, Hispanics and Caucasians.”

Study—The Effect of Hospital and Physician Volume on Racial Differences in Disease Recurrence Following Surgery for Prostate Cancer (Abstract 3416)

The study found that African Americans had a higher rate of recurrence of prostate cancer, despite receiving treatment at “hospitals or by surgeons who performed a high number of such operations.” In other words, they received equivalent care. This is contrary to previous research in which it was presumed that disparities stemmed from

Many previous studies and an Institute of Medicine report have shown that African Americans have a higher rate of prostate cancer recurrence and greater mortality. It was assumed that this was because of unequal access to care. However, in this study, when the researchers looked at the results, racial disparities persisted, even when African Americans received treatment at high-volume institutions.

Study—Differential Gene Expression in Normal Breast Tissue from African American and Caucasian Women (Abstract 43)

This is a fascinating study that identified biological differences in the expression of two genes in normal breast tissue from white and African American women, which may predispose African American women to develop “more aggressive tumors and poorer prognoses.” This may explain why tumors in African American women are “larger, more aggressive and more likely to spread to lymph nodes.”

Study—Familial Breast Cancer in a Cohort of 59,000 African American Women: the Black Women’s Health Study (Abstract 2500)

Results from the Black Women’s Health Study has found that, for African American women, having a mother or sister with breast cancer can increase the risks for developing breast cancer. This is similar to the results found in white women, however few previous studies have looked at cancer risk in African American women.

AACR Annual Meeting

Pharm Aid is covering the American Association for Cancer Research (AACR) annual meeting in Los Angeles this weekend. Watch for updates throughout the weekend.

Senate Panel Advances Medicare Direct Price Negotiations

Pharmaceutical direct price negotiations under Medicare took a step forward yesterday as a committee voted 13-8 to advance the bill to the full Senate (which is expected next week). The S.3 bill, known as the Medicare Prescription Drug Price Negotiation Act of 2007, would allow HHS to directly negotiate for lower drug prices.

Under the provisions of the bill, there would not be a mandate to directly negotiate drug prices. Rather it would simply remove the non-interference clause from the original legislation. The legislation is largely political and symbolic, as even the Congressional Budget Office (CBO) concedes the bill will have little to no effect on Medicare spending as the efficiencies are already built into the system.

I have previously discussed how this will not save the government money in
Direct Price Negotiations for Medicare? and in Direct Price Negotiations to Save Billions. And we’ve also seen what is really driving Medicare expenditures in The Truth of Medicare Spending.

The bill was authored by Max Baucus (D-MT) and supported by Sen. Kent Conrad (D-ND) and two Republicans—Sen. Olympia Snowe (R-ME) and Sen. Gordon Smith (R-OR).

Senator Charles Grassley (R-IA) has noted that Medicare is already costing the government significantly less than expected. He has said this is “political pandering” by Democratic leaders.

FDA Approves GSK’s Altabax

While GlaxoSmithKline (GSK) was trying to figure what to do about its advertising on the Imus’ show, the FDA approved Altabax (retapamulin), an antibiotic for the topical treatment of impetigo, caused by strains of Staphylococcus aureus or Streptococcus pyogenes. This is a new molecular entity in the U.S. Altabax was approved for use in children over nine months.

And the quote: “The introduction of Altabax comes at a time when antibiotic resistance is at an increasingly high level,” said Stan Block, MD, President, Kentucky Pediatric and Adult Research Inc. “Altabax provides clinicians with a convenient new means to effectively fight the bacteria that cause impetigo through an effect that is different from other antibiotics. In vitro, this new topical antibiotic has shown a low potential for the development of resistance, possibly because it works in a unique manner compared to other antibiotics.” (A pretty good quote for a drug approval press release.)

Shielding Doctors From Accountability

The movement to shield doctors from accountability seems to be growing in state houses across the country.

Yesterday, an Associated Press article by Joe Mullin discusses an expansion of New Hampshire’s physician secrecy law to other states, including Arizona, Illinois, Kansas, Maine, Nevada, New York, Massachusetts, Rhode Island, Vermont, Washington, West Virginia and Texas. Enacting physician secrecy legislation is yet another extension of the paternalistic attitudes to physicians that I have previously discussed (see A Question of Influence – Are Doctors Morally Bankrupt?).

And another Associated Press article by Ray Henry noted that there is a movement in the U.S. to enact “I’m-sorry-I-killed-your-mother” laws. The legislation is currently being considered in Rhode Island and eight other states. These laws have already been passed in 27 other states over the last four years and the AMA has lobbied for their passage. The goal is to pass legislation in which physicians can apologize for harming (or killing) patients and, potentially, shield them from accountability and malpractice suits.

I am not a fan of trial lawyers or the flood of frivolous malpractice suits. However, I am greatly concerned that shielding doctors from accountability can have a disastrous impact on patient health. Physicians make mistakes and they absolutely need to apologize for it, but creating shields of immunity are not likely to decrease medical errors (and could potentially have the opposite effect).

Animal Health Boosts Pharma?

Who would have thought?

I haven’t given a lot of thought to the animal health business in years. Last time I looked at this market segment, Pfizer was doing DTC ads for the doggie drugs Rimadyl and Revolution. Pfizer contended that animal health was the perfect compliment to its human business and, in fact, invested substantially by buying the animal health unit from SmithKline Beecham (the former Norden Laboratories).

In the late 1990’s, Pfizer was criticized for this decision since its animal health unit did not maintain the same financial margins as its recently launched blockbusters, including Viagra. At that time, animal health was a drag on the company.

And now, that decision seems quite smart (one of the few recent things to go Pfizer’s way). A recent Business Week article by Arlene Weintraub noted that Pfizer’s animal health business edged up 5% in 2006, compared to just 2% for human pharmaceuticals. Certainly not stellar growth, but every penny counts on 42nd Street.

Meanwhile, Pharmalot is writing on the Schering-Plough aquaculture business. I’m all for diversifying business, but aquaculture might be a bit of stretch for me.

If you think about it, animal health is a good fit to human health businesses. The biology is often similar and animal health products can be used to treat human diseases. An example is Merck’s effective use of the animal health product ivermectin in treating Africans (see What Ever Happened to Mectizan?).

FDA Committee Rejects Merck's Arcoxia

No surpises here, but Merck's successor to Vioxx, Arcoxia (etoricoxib), was vetoed 20-1 by an FDA advisory committee panel of outside committee of experts.

Vioxx was voluntarily withdrawn from the U.S. market on September 30, 2004 by Merck because of concerns about increased cardiovascular risks, namely heart attacks and strokes, which were associated with high-dose, long-term use of the product.

This leaves only Celebrex from Pfizer on the market in the Cox-2 class.

A final FDA decision is expected by the end of the month. It's not looking good for Merck.

New Jersey Veteos Drug Importer

The State of New Jersey has shut down the mail order pharmacy Medications4Less. Medications4Less claimed to be importing medications from “Canada” (see entry on the Realities of Importation from “Canadian” Internet Pharmacies). Medications4Less wasn’t so much a pharmacy as it was a room in Karen Azarchi’s house in Princeton, NJ. No word on if any patients died or were harmed from taking medications dispensed by this company.

According to Pharmalot, Medications4Less was dispensing drugs to state undercover agents who presented bogus prescriptions written by “fictious doctors.” Another order “involved two drugs that can cause dangerous, sometimes fatal, interactions.”

Ironically, Adam Fein of Drug Channels, found this gem of a newspaper article from 2002 touting the virtues of Karen and her company Medications4Less. Another reason to not believe everything you read in the media. The highlight of the article is a quote from Ms. Karen Azarchi stating, “I think it would be great but what would be better is if Medicare and Medicaid covered this.” How do you spell Medicare fraud?

Now, John Mack at the Pharma Marketing Blog, recently commented on this topic contending that importation is a “pharma fear” and a “negative, scare tactic.” However as this case illustrates, the risk of Internet pharmacies is more real than imagined.

Now, John Mack has asserted that counterfeit and bogus drugs are not just a problem when ordering online, but also in “neighborhood pharmacies, hospitals, or doctors.” You know, he’s right. However, I would be willing to bet that the likelihood of getting bogus meds online from Internet pharmacies that don’t check if a doctor is real or not is significantly higher than at your local Walgreen’s.

One thing is certain, this will happen again.

Physician Data and Drug Prices

Several states have been pursuing laws to restrict the collection and use of physician identifiable prescription data. New Hampshire was the first state to block the data and Nevada looks like it will be the second.

The logic here, according to a recent Associated Press article is: “Proponents say drug companies use the data to manipulate doctors and aggressively market off-patent drugs, which drives up health care prices and improperly interferes with doctors’ practices.” Really?

After I found this article on Saturday morning, I spent a large part of the Easter weekend trying to dig up any source to support the belief that access to this data drives up health care prices. I could not find a single source that would support these assertions. I did find a ton of quotes and anecdotes, but nothing documented.

And then today, PharmaLive carries a press release from the Information Policy Institute of the Political and Economic Research Council that they have done a study which proves the opposite—access to physician identifiable information actually holds down costs. The study found that the data makes biotech companies more effective in reaching “small patient populations.” It also found that without the data something called “mis-matches” between reps and doctors could amount to $1.4 billion and result and lost doctor time equivalent to 7 million patient visits.

This shouldn’t really come as a surprise, we have actually seen the same thing in other parts of health care. Transparency of information has helped to keep down prices in hospitals and insurance plans.

So what is it that doctors in New Hampshire and Nevada are really trying to achieve?

Anna Nicole Smith’s Positive Impact on Healthcare

Anna Nicole Smith was both a beauty and a joke—a caricature of all that we find admirable in the female sex. She was a former Playboy model with a strong personality who battled the demons of her weight, self-esteem and the endless criticisms of others.

I did not think very highly of her while she was alive. I viewed her with the kind of contempt that most people have for “reality TV stars.” I’ll admit to being fascinated by her TV show in the kind of way that people gawk at accidents.

Yet, in her death, Anna Nicole Smith has brought about a very important debate in the healthcare community. Smith’s accidental drug overdose, while personally tragic, was preventable. Many in the medical profession have been shocked to learn that nearly all of the prescriptions that Smith was ingesting with gusto were prescribed by the same physician—Dr. Khristine Eroshevich. My intent in mentioning this is not to find fault with Dr. Eroshevich’s professional medical judgment, which could surely be the subject of other blog entries. Rather, Smith’s death and Dr. Eroshevich’s role highlight several major problems with the health delivery system.

When I first got into the business, I had asked a physician friend to prescribe a PPI for my acid reflux, which had been diagnosed by a gastroenterologist. It was preferable to waiting months for an appointment with the gastro and dealing with HMO referrals. Citing ethics, my friend declined since it was inappropriate for him to treat me as his friend. Yet, Dr. Eroshevich was treating her friend Anna Nicole Smith. Slowly, the profession has wandered and somewhere along the way, the ethical concern of treating friends and family members has been lost.

This has coincided with the rise in opinion that physicians are not responsible for their professional medical decisions. At a recent dinner with physician, I was shocked to hear them discussing prescription errors with a detached view that it was the “drug” that caused the problem, not their decision to put the patient on it. One doctor felt no sense of ownership in his decision to put a patient with cardiovascular risk on Vioxx. I take the view that the drug wouldn’t have harmed the patient if the physician hadn’t instructed them to take it. Physicians must again “own” their professional decisions. This also includes admitting those instances in which they make mistakes. Dr. Eroshevich’s decisions led to Anna Nicole Smith’s premature demise.

The second issue that Smith’s death has raised is how a learned intermediary could not be aware of the various drug interactions. The alternative is that Dr. Eroshevich knew of the interactions, yet continued with her reckless professional behavior. Some are willing to make those charges, but I am not. Rather, I believe this is exactly the accident it appears to be. The doctor was treating the individual symptoms as they presented and was not considering the entire patient. This is not a problem with just Dr. Eroshevich, rather it is a failing of the healthcare system.

There are solutions to the problem of concomitant drug interactions. Electronic Health Records (HER)/Electronic Medical Records (EMR) could provide immediate warnings to physicians of interactions as the drugs are prescribed. This would not prevent errors attributed to “doctor shopping,” although would surely cut down on some of the 1.5 million physician prescribing errors.

A more active and comprehensive approach would be active prescription monitoring. Just as each doc has a DEA number, patients could be assigned a unique patient identifier to monitor the prescription and medical procedures they receive. This solution would also catch potential errors that slip by pharmacists when patient’s fill prescriptions at several different pharmacies. A patient ID system would certainly solve the problem. However, this is very “big brother” and too difficult for many people to swallow.

As a profession and an industry, we can view Anna Nicole’s death as an isolated incident and an oddity of Hollywood—something to be gawked at and joked about over our evening cocktails. We can allow it to be the sensational ending to the tabloid life. Or we can view it as representative of the drama that plays out in homes across America. The use and abuse of prescription products, and the doctor’s role in this crisis, is not a problem that the profession can sweep conveniently into the closet.

This lesson was brought home to me recently on a flight when I sat next to a family with a high school junior. She had a friend at her high school who passed away from an overdose of ativan. People, particularly young people, find it easy to get their hands on these powerful medications, and many physicians are eager to assist. Unless we take the problem seriously, there will be many more deaths like Anna Nicole’s. I hope we take the lesson of Anna Nicole Smith’s death as a prescription for a change.

The Week Ahead – April 9-15

April 10-11 – The Health and Human Services Department (HHS); Office of the Secretary of Health and Human Services' National Vaccine Program Office is holding a meeting on "Vaccine Safety Evaluation: Post-marketing Surveillance.”

April 11 – The FDA is holding the Anti-Infective Drugs Advisory Committee to provide advice and recommendations to the agency on regulatory issues in Rockville.

April 11 – The FDA is having a meeting of the Pediatric Advisory Committee to review adverse event reports for fluvastatin (LESCOL) and octreotide (SANDOSTATIN) and to receive updates to adverse event reports for orlistat (XENICAL) and oxybutynin (DITROPAN).

April 11 – The Senate Finance Committee for Medicare Advantage Program is holding a full committee hearing on "An Examination of the Medicare Advantage Program." Witnesses: Peter Orszag, director of the Congressional Budget Office; Glenn Hackbarth, chairman of the Medicare Payment Advisory Commission; Debra Draper, associate director at the Center for Studying Health Systems Change; and Steven Udvarhelyi, senior vice president and chief medical officer for Independence Blue Cross.

April 12 – The FDA is holding a Arthritis Advisory Committee. The committee will discuss the new drug application (NDA) 21-389/21-772, ARCOXIA (etoricoxib), Merck & Co., Inc., proposed treatment for the relief of signs and symptoms of osteoarthritis.

April 12 – The Centers for Medicare and Medicaid Services and HHS are holding a listening session on the “Draft Plan for Medicare Hospital Value-Based Purchasing.”

April 14-18 – The American Association for Cancer Research (AACR) is hosting their annual meeting in Los Angeles.

More Flu Drug Drama for Biota

I find myself spending a great deal of time on flu this week. Yesterday’s news of resistance with flu drugs like Roche’s Tamiflu and GSK’s Relenza refocused my attention on Biota’s lawsuit against GlaxoSmithKline.

When I first wrote on this last week, consultants for Biota were implying that Relenza did not have the same resistance issues as Tamiflu, and was also a potentially superior drug (and deserving of a much larger market share if it weren’t for GSK’s failure to market the drug). Yesterday’s JAMA study appears to undermine the resistance assertions showing how the virus itself is prone to changes. In fact, a case could be made that Relenza’s poor market share has meant the virus has not had the chance to develop resistance.

Biota and their consultants have not responded to my requests (four in total) for the medical studies to support their lawsuit or more information, although I was able to find some information myself. Interestingly enough, the Lancet article that Biota cites does indicate that Relenza may be superior (vindicating Biota’s claims), however it also gives us a picture as to why Relenza’s market share is not what Biota was expecting—dosage and administration.

With Tamiflu, patients take an easy-to-swallow capsule or liquid. With Relenza, patient’s need to follow a complex set of instructions, which includes: watching an educational video to figure out how to take the medication, then following the 6-step process to load the medication into the inhaler, then the 4-step procedure to puncture the blister, followed by the 4-step inhalation process, and then the 3-step advancement process. For a doctor, which is easier—tell the patient to pop a capsule or follow a five page set of instructions? I got lost trying to follow the little white tray with the silver disk and the half-circle.

In Biota documents, we get a glimpse at their solution to the inflexible form of dosing an inhaled medication—Intravenous administration. Somehow, I think patients (and their doctors) will still prefer the oral Tamiflu. It is GSK’s lack of push for a new IV formulation that Biota cites as one of its major complaints.

And Biota wonders why their market share is negligible compared to Tamiflu? Was it GSK’s lack of support for the product? Or is it that Relenza is a potentially superior product with a terribly inconvenient method of delivery, thereby being used in only more complicated and advanced cases?

I love small start-up companies, especially biotechs. I love the underdog. You want to back the small partners in these deals. Having been through nearly 100 pages of Biota documents, I believe this entire case rests squarely on assumptions made by Biota’s management of sales and market share for the product. These assumptions were developed during a time when Relenza had no competition, much less a competitor offering a significantly more convenient delivery system.

Abbott’s Thai AIDS Problem

Abbott is really taking a hit these days.

First, the military junta in Thailand that deposed of the Prime Minister, declared martial law and suspended the constitution has announced it would issue compulsory licenses for Abbott’s Kaletra, thereby violating World Trade Organization (WTO) regulations. While WTO regs gives countries the option to grant compulsory licenses in times of national emergency, this isn’t one of them. Abbott is powerless to stop the compulsory licensing of its products.

With the Thai government holding the company hostage and looking down the barrel of the gun, the company is refusing to register its products in the country. Frankly, what other choice do they have? It’s like the guy who tries to rob you for your watch and you know he’s going to shoot you anyway.

Meanwhile, Abbott is being criticized on the homefront by abbottsgreed.com, a wiki launched by activist groups such as Health Gap and Students for Global AIDS Campaign, who are criticizing the company and trying to pressure it into giving its products away.

Abbott has yet to take any kind of stand. No press release. No media statement. No posting on its website. Ed at Pharmalot makes the point that they are losing the public relations war. But it seems like the Abbott folks haven’t even shown up.

A Mixed Week for Pfizer

It’s been a mixed week for Pfizer. First, Pfizer/Pharmacia settled with the Department of Justice (DoJ) for $34.7 million to resolve matters related to off-label promotion of Genotropin.

And in the win column, the U.S. Supreme Court rejected an appeal by Ranbaxy Laboratories in its now failed bid to challenge Pfizer’s patent on Lipitor.

Still too soon to say if the tides are turning...

National Legislative Association on Prescription Drug Prices Disappears?

So, the seven state legislators that call themselves the “National Legislative Association on Prescription Drug Prices (NLARx)” seems to have gone out of business (thanks to Mike Porter for the tip!). I first wrote on this group about a month ago. Of all the ironies, the NLARx website now sells virility pills! I tried calling the group’s phone number earlier today and got a busy signal for several hours. Looks like they have finally folded.

It’s a shame really. Before beginning its new life of selling sexual enhancement products, the NLARx website contained of wealth of myths and urban legends about the pharmaceutical industry. But one such tidbit really caught my attention and made me wonder if they had gone from eccentric to just plain dillusional. They claimed that someone showed up in their offices in Maine requesting a copy of their IRS Form 990. NLARX even put out a press release about it (see below; thanks again to Mike for grabbing a copy of this before the site went away).

My initial reaction was that this was masterful publicity stunt from a marginal, grassroots organization. In the past, this has worked very well for the fringes of the environmental movement. You fabricate an incident in which you are the victims of a vast conspiracy of the industrialized, pro-globalization community in order to gain sympathy and credibility. Initially, it seemed like this National Legislative Association on Prescription Drug Prices was creating just such an incident.

However, I decided to take the organizations’ Executive Director, Ms. Sharon Treat at her word, “that being public information” she would be happy to “oblige.” So for the last month, I have attempted to obtain a copy of the National Legislative Association on Prescription Drug Prices IRS Form 990 (directly from them). The outcome—two ignored e-mails, one ignored fax and one hang up when I called them. Unfortunately, they are not registered with the non-profit clearing house GuideStar. Evidently the only way to get a copy of the Form 990 from this organization is to show up at their offices unannounced and demand a copy—just like the “mysterious man posing as a blogger” (I wish I had thought of it first).

Legitimate organizations from the Epilepsy Foundation to the Nature Conservancy and groups in between all put their IRS Form 990s on their website. Why not the National Legislative Association on Prescription Drug Prices? What is the National Legislative Association on Prescription Drug Prices trying to hide? Why did they make such a fuss about a tax form and put out a press release about it? Why is this group going to such lengths to keep this information a secret? Who is truly behind this organization? Ms. Treat, inquiring minds want to know.

NATIONAL LEGISLATIVE ASSOCIATION ON PRESCRIPTION DRUG PRICES
MYSTERIOUS SO-CALLED "BLOGGER" VISITS NLARx OFFICES

Who sent him, and what was he really looking for?
Media Advisory

Call us paranoid, but the visit last Friday to our remotely located offices in Hallowell, Maine by a mysterious man posing as a blogger seeking financial information on the National Legislative Association on Prescription Drug Prices has us wondering who or what is behind it all. Refusing to give us a business card, and providing what turned out to be fake contact information, a man showed up seeking copies of our IRS 990. That being public information, we obliged, but we wondered why drive up from New Hampshire (he said) to get a document that could have been faxed? And why would someone with a blog (oh, sorry, no name or web address, he hasn’t actually started it) seek such information in the first place? And why was the phone number he gave us out of order? And was he connected to the mysterious woman calling our office the day before from (she said) Massachusetts , asking where our offices are located but refusing to give her name? Who sent this guy, and why go to such lengths to keep your identity a secret? What was he really trying to find out? And why did he peel out of the public boat landing parking lot nearby in his late model car faster than you can say “Karasik Conspiracy”?* Inquiring minds want to know.

April Medical Meetings

Each month I will highlight a few upcoming medical meetings that are both significant and interesting—

April 14-18 – American Association for Cancer Research (AACR) Annual Meeting in Los Angeles.

April 28-May 5 – American Academy of Neurology 2007 Annual Meeting in Boston.

Partnership for Prescription Assistance Turns Two

The Partnership for Prescription Assistance (PPA) celebrated its second anniversary today. The program has provided free or deeply discounted meds to over 3.6 million struggling Americans. It's a shame that drug companies unjustly get a bad reputation for not helping the poor and unfortunate.

I’m also thankful that industry opponents have not figured out the real motivation here. By giving the poor and unfortunate in America free drugs, the industry enables people to spend their money on things like McDonald’s, cigarettes, and alcohol, leading to unhealthy lifestyles and driving the need for additional pharmacotherapy. It's a vicious cycle.

Free drugs are a loss leader for a lifetime of dependence by the welfare class!

Now pass the fries...

Flu Drug Resistance

Who would have thought that antivirals for the flu could generate so much excitement? It makes me long for the annual visit to the Today Show by the Flu Bugs.

Today’s news from the Associated Press is that a study in the Journal of the American Medical Association (JAMA) found that a strain of flu in Japan is developing resistance to antiviral drugs—namely Roche’s Tamiflu, but potentially GlaxoSmithKline’s Relenza. Previous studies had documented resistance with Tamiflu, but this shows a potential class effect.

This comes on the heels of Japan dealing with a rash of adverse events in which “odd behavior” is observed in children taking the drug Tamiflu. These odd behaviors include suicide (which isn’t all that odd if you’ve ever spent any time in Japan) as well as the “overwhelming desire to hop” (yeah, that’s odd). The ever watchful Japanese Health Ministry issued a warning to doctor’s about these odd behaviors last month.

And soon all the drug firms will be looking into their pipelines for the next promising compound.

Direct Price Negotiations to Save Billions

Or will it?

Bloomberg is reporting that direct price negotiations would save the U.S. over $30 billion, according to a new report released by Senator Debbie Stabenow (D-MI), who is back from her Generic Pharmaceuticals Association (GPhA) junket to the golf and spa resort in Arizona.

I personally have doubts that this will save money based on the government’s historic inability to effective negotiate anything. Former CMS head McClellan has said that this an “apples to oranges” comparison because the VA relies on mail order and tight formularies compared to a retail-based approach in Medicare. At any rate, let’s assume that the two systems are analogous and that it will save money. At least initially.

The first issue is that the VA formulary is restrictive. The Institute of Medicine has been quoted as saying that the VA formulary is “not overly restrictive.” Which is a good thing, especially if it “almost covers drugs that might save your life.” It’s only “not overly restrictive” if its not your parent or grandparent who can’t get the medicine she needs because of “formulary restrictions.” Did we not learn anything from the HMO debacle of the 1990s?

Of the 77-priority reviewed drugs from 1997-2005, only 22% were on the VA formulary. This restrictive formulary has meant that new and innovative treatments for HIV/AIDS and other chronic medical conditions are often delayed on the VA formulary or never included.

So I contend that direct negotiations might save some money initially (given the overly optimistic assumption that government negotiations are effective). However, as seniors (and AARP) realize that life-improving and life-saving medications are being delayed from reaching them, they will begin lobbying Congress to expand the formulary, thereby diluting/eliminating any potential cost savings.

A Modest Proposal for America’s Seniors

While flipping through Business Week magazine, I spied a fascinating article entitled, “Thank you for dying,” and I realized that we finally had the solution to America’s healthcare crisis. The tongue-in-cheek article comes from the new Christopher Buckley novel “Boomsday.” However, I see no reason why his modest proposal could not be successful.

You see, the problem with healthcare isn’t really a problem. It’s the perception of a problem. The system works, it’s just that seniors are now expecting more entitlement perks than the program was meant to provide. However, there is a solution!

The solution to America’s healthcare crisis is mandatory lethal injections for all seniors at age 65. This eliminates countless problems—social security, the healthcare crisis, exploding Medicare costs—that America’s seniors are forcing onto their children and grandchildren. This would be a beautiful and selfless act from the “Me Generation” of self-absorbed Baby Boomers who are receiving their AARP cards.

And that, my dear friends at AARP, is the answer. You’re right. “I think we can do better. A lot better.”

Kaiser Family Foundation Election Tracking Poll

The Kaiser Family Foundation has launched a new health/election tracking poll. I always love these rule-of-the-mob polls.

However, there are some interesting insights here. First, the cost of prescription drugs didn’t rank as one of the five most important health issues. Second, according to Kaiser, the majority of Americans favor universal healthcare. Count me as one of them, just don’t force me or my family into the program. There’s a reason why people in the UK, Canada and other countries with socialized medical systems “opt-out” for some services—poor quality (which, incidentally, ranked fourth on the Kaiser partisan poll).

Does anyone else remember when the Kaiser Family Foundation was actually credible and non-partisan?

Prescription Drug Expenditures

Much is made of the ever escalating prescription drug prices. Are prices increasing? Sure, so is the price of milk. But is it relevant?

Last week, I received my annual copy of the “Medical Cost Reference Guide: Facts and Trends Supporting Knowledge-Driven Solutions” published by the folks over at the BlueCross BlueShield Association. Arguably this is one of the most comprehensive and least biased reports out there and stands in stark contrast to the partisan puff-pieces published by Kaiser Family Foundation and others.

One thing struck me, prescription drugs are still 10% of the healthcare dollar.

With all the talk about how prescription drug prices are growing so much faster than everything else, you’d expect that the percent of prescription drug expenditures would be increasing every year. It isn’t.

In fact, the report shows that both payments to physicians and hospital expenditures are increasing faster than prescription drugs (for 2004, the most recent year for which information is available). Prescription drug growth rates have declined every year since 2000.

I went back and looked at old Drug Trend reports from Merck Medco, Express Scripts and others from 1996-1999 (just a decade ago). You guessed it—prescription drugs accounted for just 10% of the healthcare dollar.

To be fair, in certain private insurance plans (which account for 35% of the total market), prescription drugs have risen to just under 14% of the healthcare dollar…all due to increased utilization. In other words, people with better insurance take more drugs because they can. And that is a fundamentally different problem than increasing drug costs.

Cancer Vaccines Back in the News

Back in 2002, it seemed like hardly a week would go by without a news story about cancer vaccines. They were quite the rage at the BIO annual meeting. And then, they seemed to fade into the background.

Well, cancer vaccines are back, driven partly, by approval of Merck’s Gardasil. Therapeutic cancer vaccines are making news again. An FDA advisory committee is backing approval of Dendreon’s Provenge.

sanofi-aventis’ is getting back in the cancer vaccine game with a $690 million deal for Oxford BioMedica’s TroVax vaccine. TroVax is moving through Phase III trials for renal cancer and pipelines for colorectal, lung, breast and prostate cancers. No word on where this leaves sanofi-aventis other cancer vaccine program.

Finally, there’s a buzz about cancer vaccines at this year’s AACR. There are nearly 200 posters and presentations on cancer vaccines this year and I’m expecting some very interesting results.

The Week Ahead – April 2-6

April 3—The American Enterprise Institute for Public Policy Research is hosting a discussion, "Is There a Solution to the Medicare Physician Payment Problem?” The discussion is in response to the upcoming cuts to the Medicare fees paid to physicians, which will be cut automatically 10 percent next year, with additional cuts of about 5 percent every year beginning in 2009. Physicians are protesting the cuts.

April 3—George Washington University School of Public and Health Services is hosting a discussion, "Protecting the Nation's Health: Major Challenges of the 21st Century.” The panel will feature six former directors of the Centers for Disease Control and Prevention (CDC), including Jeffrey Koplan, David Satcher, William Roper, James Mason, William Foege, and David Sencer.

April 4—The Senate Finance Committee is hosting a ski-season junket to Billings, Mt. for a field hearing "The Children's Health Insurance Program (CHIP) in Action: A State's Perspective on CHIP." Included in the discussion is Barbara Lyons, deputy director of the Kaiser Family Foundation Commission on Medicaid and the Uninsured; Joan Miles, director of the Montana Department of Health and Human Services; Janis Langohr, a pediatrician with the Children's Clinic in Billings. Attending the session is Max Baucus (D-MT) and Charles Grassley (R-IA).