Prostate Cancer Pessimism in the Pepto-Pink Season

I’ve been spending a lot of time traveling over the last few months, and that gives me the opportunity to read a lot of news. In case you’ve missed it, there is an all out war on the men with prostate cancer in America.

It is a fact that PSA tests will diagnose men with prostate cancer that will develop a form of the disease that does not progress. In some men, “watchful waiting” is prudent medical advice. However, there are some in America (including some currently lobbying hard for the passage of healthcare reform in Congress) that would like to see no PSA testing at all for prostate cancer and “watchful waiting” should be the mandatory default step.

Forgive me for sounding jaded, but at my age, I’ve seen a lot of shit. And that’s just what this is. It is sex discrimination, plain and simple. If I proposed for one minute that we NOT treat women with breast cancer, the Susan G. Komen drones would assassinate me. Period. And right they should.

Withholding proven science because of concerns of “over-diagnosis” and “over-treatment” is equivalent to medical malpractice and voluntary manslaughter. Plain and simple. As a man, I get really concerned when I hear the chorus of care rationing coming from Washington, D.C. because it costs money to treat men with prostate cancer. And I get downright pissed off when people begin talking about the 30,000 men who die of prostate cancer every year as “acceptable deaths” because they helped keep costs down. Somehow, I doubt there would be the same response to the 40,000 women who die every year of breast cancer.

It comes down to this: the “system’s” (i.e., the Government, greedy insurance companies, or activist do-gooders) desires to control costs regardless of the outcome is directly opposed with the individual’s desire to live. This is not making healthcare decisions on what is in the best interest of the patient, it is making healthcare decisions in what is in the financial interest of the payer. There’s a big, big difference.

And all of this brings me to Dendreon. Poor little Dendreon has sodomized from Washington State to Washington, D.C. It’s product Provenge was torpedoed by a greedy doctor in a get rich quick scheme. Subsequent trials have demonstrated what we all knew the first time – Provenge should have been approved, it is safe, and it is effective.

But along the way, Dendreon has had to publicly battle the FDA. That battle has proved very time consuming and expensive for Dendreon. And it has been extremely embarrassing for the FDA. Over the last six months, I still had a high degree of optimism that the FDA would eventually allow Provenge to be approved once it had let the bruises heal.

My optimism is gone. I’m convinced the wounds are too great at the FDA to allow this one to pass (although I would love it if I’m proved wrong). Dendreon maintains its optimism (including this recent press release), but I think they are just continuing to be naive.

As FDA begins to make more and more decisions in back-room deals that have nothing to do with science or medicine (but have a lot to do with politics, financial payoffs and cost containment strategies), I’m convinced that Provenge will never be approved for the treatment of prostate cancer. I bet Provenge would have been approved for breast cancer – had it treated breast cancer. But, it seems the prevailing medical theory is that men need “watchful waiting” until they die, while women deserve medical treatment.

As we enter Pepto-pink Breast Cancer Awareness Month and the flood of pink products and paid-off celebrities trying to sound like they care, I’m not very optimistic about other cancers (including prostate cancer and pancreatic cancer).

Public Option Goes Down in Flames

In a bi-partisan effort, both Democrats and Republicans joined forces to defeat the controversial “public option” in healthcare reform legislation. The public option has been advocated by liberal Democrats, but today’s vote makes it all by impossible for the option to ever pass.

As one of the AARP set, I have to wonder why anyone would want to be on a government health program. It’s not like Medicare is wonderful. I’ve been struggling to find doctors that will actually accept Medicare. What good is a government program if doctors won’t take it? What good is a government program if it doesn’t help you?

Sequenom Sacks Senior Leadership

Upstart diagnostic firm Sequenom sacked nearly all of its entire senior leadership team today after completing a probe of its internally testing processes. Those fired include president and CEO Harry Stylli and R&D chief Elizabeth Dragon. The CFO, Paul Hawran, was able to resign gracefully.

So, it goes like this – in April, Sequenom announced that it could not rely on ANY data from its pivotal trials of its SEQureDx test used to test for Trisomy 21 (a.k.a. Down syndrome). Excuse me?

The company has said: “The company failed to put in place adequate protocols and controls for the conduct of studies in the Trisomy 21 (Down syndrome) program… Certain of the company’s employees also failed to provide adequate supervision…” In other words, mistakes were made. However, how does a company botch something this big and not have it be willful? How is it not criminal? And how can any self-respecting Board of Directors NOT pursue damages from the dismissed executives?

And sure enough, there’s a shareholder lawsuit in the making.

Abbott to Acquire to Solvay’s Drug Unit

The Wall Street Journal is reporting that Abbott Laboratories will acquire Solvay’s pharmaceutical unit for $7 billion (about Euro 4.8 billion). Abbott and Solvay have already been in partnerships together for several drugs, including Tricor and Trilipix.

Abbott has relied on Humira to pull it through in recent years. Humira now faces yet another major competitor in the form of J&J’s new Stelara, which was approved by the FDA on Friday.

Complete details of the deal should be announced on Monday.

India Quietly Weighs in On ObamaCare; Exporting Jobs

It’s unusual when a foreign government weighs in on another country’s domestic issues. It tends to incite a very negative reaction in the domestic country. But such was the case this weekend. Officials from India came to Chicago to make their case to a small gathering of healthcare executives. Gathering in the Chicago hotel to hear the Indian Government’s pitch were the heads of several major U.S. pharmaceutical companies, medical device firms and at least five significant biotech companies. Each executive brought a small contingent of confidants and legal counsel – packing into the small meeting room and clustering around round tables with colors to identify themselves – no name badges, no company names, even the meeting room was identified only with the generic listing “Training Session.” It was all very secretive – and quaint.

And what a pitch it was. The Indian Government did an amazing job starting off the presentation by highlighting their growing role in the pharmaceutical industry. The leading provider of the world’s API. They are a growing powerhouse in the generics industry (although, as readers of Pharm-Aid know, I have been very critical of the Indian generics industry for poor quality control standards and corruption among Indian company officials). Yet, the executives in the room knew all of this. I don’t think there was anyone in the room who hadn’t been to India at least once to see this first hand. This was only to be the amuse bouche for the main event.

The main event was a panel of noted academics, industry experts and think tank gurus to discuss the impact of ObamaCare on the U.S. market. From the $80 billion cut in pharma reimbursement to the $40 billion medical device excise tax, the U.S. market wasn’t what it once was. The panel discussed in mind-numbing detail the numbers of what ObamaCare finance reform would to do the healthcare industry. While nearly every company engages in some degree of outsourcing (from API to contract manufacturing, etc.), nobody has gone all the way – yet.

And then came dessert. An Indian official took the podium and began outlining what India was willing to do for companies that wanted to bring jobs. Do you want to open an R&D center? India has significant incentives. Who is going to run these facilities? You can – through extremely generous expatriate packages. He called Obama’s health reform initiative the single greatest opportunity in global outsourcing the world has ever seen – and he is right. India’s opportunity is America’s lost jobs.

This is a period of incredible change in the United States. The pharmaceutical and healthcare industries have been a growth engine for the U.S. over the last 40 years. Over 700,000 people are directly employed in pharmaceutical related jobs and another 2.5 million people rely on the pharmaceutical industry for their livelihood. No country in the world can compete with the level of innovation that has occurred here. The U.S. has been the gem of the world’s envy. Are those days gone forever?

The general tone from this weekend’s meeting of healthcare executives is that we’re on the cusp of taking the last great American industry and destroying it. Current proposals from President Barack Obama and Congress would turn the healthcare industry into something like the automotive industry – unprofitable, ignorant, stagnant, dependant on government subsidies and of such inferior quality as to be laughable. We’re going to take BMS, Amgen and Genentech and turn them into Ford, Chrysler and General Motors (Note: for the record, I’m not saying BMS, Amgen or Genentech were at the meeting, I’m only using them as an example of companies that have been strongly innovative). It’s a sad, sad day for American innovation.

You have to give credit to the Indian government for identifying a real opportunity here. Without a doubt, healthcare reform will fuel outsourcing and the exportation of American jobs.

Sanjay Gupta Gets H1N1

This is a little outside my normal coverage, but I thought it interesting that CNN’s Dr. Sanjay Gupta contracted H1N1 flu in Afghanistan earlier this week. He noted his experience on his personal blog.

As the winter flu season gears up this winter, I think there will be a lot more discussion of H1N1. Hopefully, the media will cover this issue responsibly. After the coverage this past Spring, in which all of us were going to die of swine flu in a matter of days, I started to tune out the coverage. Is H1N1 serious? Sure. But the media-instilled panic was reckless.

I’m glad that Dr. Gupta is better. Hopefully his personal experiences will inform a more responsible degree of media coverage on CNN and other media outlets.

J&J Gets Stelara Approved – Finally

On Friday, Johnson & Johnson’s Centocor Ortho Biotech division received approval for Stelara (ustekinumab) for the treatment of psoriasis. It’s new mechanism of action, which is probably why the FDA spent over two years reviewing the drug. So much for PDUFA deadlines.

Stelara offers quarterly dosing every 12 weeks, with equivalent efficacy to other drugs on the market.

So the real question is – what took so long? Was J&J distracted in its internal merger of Centocor and Ortho Biotech? Was J&J slow in its responses to the FDA? Was the hang-up at the FDA due to the new mechanism of action? I think it’s safe to say that it has been many years since I’ve seen a review take this long at the FDA.

There are some pretty significant adverse events with Stelara that patients should be aware of – including an increase in the risk of cancer. Stelara has also been associated with at least one case of reversible posterior leukoencephalopathy syndrome (RPLS) – a rare condition that can affect the brain and might lead to death.

In Canada, Stelara costs between CAN $18,000-$33,000 a year. Individual patient costs in the U.S. will depend on formulary adoption. Given the number of other options on the market, it will be interesting to see what kind of up-take J&J/Centocor Ortho Biotech will get. J&J is expecting sales of half billion in the next few years.

Reference: Reuters and J&J Press Release

Healthcare Reform Gag Order

As President Barack Obama has been unable to win over the American voters based on the merits of his healthcare reform plan, he has begun resorting to secrecy and McCarthyist techniques. Actually, let me clarify my comments, as President Obama doesn’t actually have a healthcare reform plan, but Senator Max Baucus does. Yet still the Obama/Baucus alliance continues to trying woe support for their failing healthcare bill.

President Obama himself addressed a joint session of Congress and promised not to cut Medicare benefits. It was a promise he couldn’t keep. And Baucus is moving forward with the healthcare reform package that will eliminate over $120 billion in coverage for Medicare patients and nearly 3 million American Seniors will lose Medicare coverage altogether. That’s not rhetoric, it’s a simple statement of fact. Now, that’s as the bill is currently conceived by Senator Baucus and President Barack Obama, and it’s possible it could change at some point in time. But what’s interesting is these dire assessments aren’t coming from screaming right-wing neoconservatives, they are coming from the non-partisan Congressional Budget Office (CBO), which has consistently underestimated the cost of every healthcare bill before Congress since 1965. It’s likely the real damage of ObamaCare could be much, much worse.

But here’s the new wrinkle in the healthcare reform debate. Senator Baucus leaned on President Barack Obama to pressure the new puppet director at CMS, Jonathan Blum, to issue a federal gag order not to discuss any aspect of the healthcare reform bill. Even if it’s written in Senator Baucus’ bill, nobody is allowed to speak of it – unless you are supporting the healthcare reform bill. How did this happen?

Earlier this week, it was revealed that Humana sent a letter to Medicare Advantage beneficiaries stating exactly what is in the healthcare reform bill. Humana provided objective statements of fact and provided its customers with an early warning their benefits might change. So, why is it that President Barack Obama and Senator Max Baucus are afraid of the truth? Why is it that they don’t want the American public to know exactly what is in their little healthcare reform bill? How is this Democratic?

Here’s a thought: why doesn’t Humana CEO Michael B. McCallister openly challenge President Barack Hussein Obama to a public debate? Obama has proclaimed from the Congressional floor that he is open to a civil dialogue, why doesn’t he prove it? President Obama isn’t able to convince Americans of his proposals on merit, so he’s resorting to intimidation and Constitutional abuses.

Healthcare Reform – Where’s the Beef?

President Barack Obama gave his 29th speech on healthcare reform tonight to a joint session of Congress. Two things really struck me about Obama’s speech – his new insistence that you can keep your own doctor and his new insistence that his plan won’t add anything to the budget deficit (a deficit that Obama has pushed to $9 trillion dollars through his various social programs).

First, Obama’s claim that: “If you have insurance…nothing will REQUIRE YOU to change the plan or doctor you already have.” Well, yes and no. For a speech in which he challenged Republicans to honesty, I was really disappointed by this spin from Obama. First, it’s true. There are no explicit words in the bill that will force you to change your doctor under penalty of death. It doesn’t exist. But you also probably won’t be able to keep your doctor. In fact, it’s happening already.

Let’s look at Medicare. There’s nothing in the Medicare laws and policies that force you to change your doctor. So Obama’s right. But you try to find a doctor who takes Medicare. This isn’t partisan. Take it from the New York Times – doctors are dropping Medicare like a hot potato. Let me give you my own experience. I recently tried to find an oncologist who takes Medicare in my area. The first 12 doctors I called would NOT accept Medicare. So, you have the Government picking up the tab for your healthcare, but you can’t actually get care. [By the way, I’m still searching for a good oncologist in the Eastern Pennsylvania area that takes Medicare – let me know if you know one.]

Second, Obama has claimed that he will not add a dime to the federal deficit. After, he’s added another $7-13 Trillion (depending on who is doing the counting); President Obama has decided that enough is enough. He’s not going to add any more to the federal deficit…and he’s not going to cut care for Americans. Personally, I’ve heard this dozens of times from various President’s over the last 50 years. “We’re going to trim the waste out of the system.” How? Is he going to trim “waste” like diagnostic test for colorectal cancer? For those who don’t know, earlier this year, Obama’s Administration pressured CMS to not cover virtual colonoscopies for America’s seniors. Obama’s actions speak louder than his words.

Like nearly all of America, I turned into the Obama’s speech expecting to hear something new – leadership. President Obama did look and sound very Presidential. But I was left with a “where’s the beef?” feeling. I didn’t hear anything out of Obama’s mouth that I haven’t heard before. It was a broken record experience for me. I was hoping for some fresh ideas and some real leadership, not tired partisan politics with a healthy dose of Bush bashing.