Pharm Aid

IMS Health Sells Out

noreply@blogger.com (_) — Sat, 07 Nov 2009 02:37:00 +0000

As predicted a few weeks ago, IMS Health has sold itself to private equity for $5.2 billion ($4 billion in actual transaction, plus the acquisition of another $1.2 billion in debt). The buyers were private equity firms Texas Pacific Group (TPG) and the Canadian Pension Plan (CPP) Investment Board. The deal works out to $22 a share. I’d look for the new owners to break up the company – slipping the high-profit prescription data business from the consulting organization.

IMS has really struggled since the current CEO, David Carlucci, took over. The company recently lost a very high-profile legal challenge against the State of New Hampshire prohibiting sales of prescription data that identify individual physicians (there’s a little more to it). IMS vigorously defended itself in a costly legal battle that tapped the company of a significant amount of cash and proved to be a considerable distraction with customers.

Already, some law firms are looking into the deal on behalf of shareholders. While the deal represents a nice premium over the last 12 months (IMS’ shares have been in the toilet since long before the recession hit), it is well below the $31.49 of October 2007 – just two short years ago (and the high $20’s where the stock has traded for much of the past 5 years).

This deal is a rather significant windfall for IMS executives who received thousands of shares over the last few years. This deal is also the end of the once-formidable pharmaceutical market research firm. The only remaining question is: which company will take over reins in the industry?

A New Look for Pharm Aid

noreply@blogger.com (_) — Thu, 05 Nov 2009 01:34:00 +0000

Change is in the air. That holds true for Pharm Aid. We’ve just launched our new logo, both here and on Twitter. Let me know how you like it.

Health Reform Fuels Job Losses

noreply@blogger.com (_) — Wed, 04 Nov 2009 03:02:00 +0000

Healthcare reform efforts are driving further job cuts in the healthcare, pharmaceutical and medical device industries. What started as a rationalization of sales forces and a response to the global recession has accelerated in response to health finance reform legislation pending before Congress.

As noted in the Wall Street Journal Health Blog, there have been significant cuts. Today, Johnson & Johnson announced 8,000 jobs will be cut. Previous major layoffs include the Pfizer/Wyeth 20,000 cut, Eli Lilly’s decision to cut 5,000 jobs, and AstraZeneca’s 7,000 job elimination. And by adding them up, the Wall Street Journal gets to 40,000 job cuts.

I believe that is underestimated by at least half. And here’s why. These were only the major cuts and the only the ones that caught big headlines. There have been many other more subtle layoffs, including Merck/Schering (16,000) that will materialize soon, Caraco Pharmaceuticals (450), BMS (113 in Indiana), and Charles River (115). Other companies have not quantified their layoffs.

Most bluntly, Boston Scientific CEO Ray Elliott has indicated that Obamacare would cost his company an additional 1,000-2,000 jobs.

Into this fray, countries are stepping in and making a valiant pitch to American and European companies to outsource jobs there. These countries offer compelling financial incentives without any of the entanglements offered by the Obama regime.

One thing is certain, healthcare reform as envisioned by President Obama will accelerate American job losses.

Obama Promises H1N1 Vaccine - Again

noreply@blogger.com (_) — Wed, 04 Nov 2009 00:54:00 +0000

While I previously wrote about the White House Admission of Significant Mistakes on H1N1, things have deteriorated over the last 48 hours. Obama mouthpiece Robert Gibbs noted that President Barack Obama is frustrated with the H1N1 flu vaccine shortage. Gibbs also promised that President Barack Obama is personally tackling this issue “each and every day to fix this.”

That’s terrific, but President Obama needs to take much of the responsibility for the current H1N1 vaccine mess. It’s absolutely negligent that President Obama has waited so long to take H1N1 seriously. While President Obama spent 24 days golfing or taking a lavish vacation on Martha's Vineyard, H1N1 could have been addressed in a meaningful and significant way. Let’s face it – President Obama’s actions have been far too little. Now that Obama has his head out of wherever it was, hopefully it isn’t too late.

Don’t get me wrong, H1N1 isn’t an issue that the President needs to personally solve. Unfortunately, President Obama nominated Kathleen Sebelius to the job of HHS Secretary and that’s when the trouble started, so now Obama needs to compensate for Sebelius' significant shortcomings. Secretary Sebelius looks great in a St. John’s suit, she’s a staunch supporter of abortion and she's a great fundraiser for the Democratic Party. Unfortunately, that’s where Kathleen Sebelius’ qualifications end. She is woefully ignorant of healthcare issues and is in way over her head on public health issues like disease outbreaks. One has to wonder if we had a competent HHS Secretary whether we’d be in the same pickle we’re in.

Unfortunately, the Obama Administration has had yet another misstep with the H1N1 vaccine. While millions of Americans can’t get access to the vaccine, the Defense Department has announced that terrorist detainees at Guantanamo Bay will receive the H1N1 shots. Obama spokesman Robert Gibbs quickly backtracked saying that terrorist suspects won’t receive the vaccine because: 1) there is no vaccine currently in Guantanamo Bay and 2) there is no H1N1 vaccine currently being shipped to Guantanamo. The Pentagon noted that Gibbs is technically correct at this point in time, but immunization of Guantanamo inmates will commence later this month – long before millions of American citizens have access to the vaccine. That’s a huge political embarrassment for President Obama.

I’m glad Obama is finally taking H1N1 seriously, but I resent that thousands of Americans are dying of flu while President Obama has been distracted by his extracurricular activities – golfing, basketball, finding a dog for his daughters and lavish vacations in Martha’s Vineyard. We’re in the middle of a public health crisis and it’s time for President Obama get in the game.

Source: Reuters

White House Admits H1N1 Mistakes

noreply@blogger.com (_) — Sun, 01 Nov 2009 02:00:00 +0000

In speaking with NPR, senior Obama advisor David Axelrod admitted to serious mistakes in the White House’s handling of H1N1. Namely, it is the White House’s assessment that they overpromised on the country’s flu readiness and vaccine availability for H1N1. While offering a half-hearted apology, Axelrod also attempted to blame the shortage on information that was provided to them (presumably by vaccine manufacturers).

The White Houses’s reaction doesn’t seem be grounded in planet earth. When the CDC gave initial strains to vaccine manufacturers, it didn’t take for nearly all of the manufacturers. So, they needed to do it over again – a delay by the CDC of several weeks. Vaccine manufacturers had been advising the White House on production delays since August while the White House continued its overly optimistic assessments.

Overall, I think the CDC and the Federal Government has done a really good job counseling on flu prevention and basic sanitation. I think the CDC has done a pretty poor job in managing the vaccine distribution process. And I think HHS Secretary Kathleen Sebelius has done a pitiful job in managing the crisis overall and bringing the full resources of the Federal Government to the crisis. It took President Obama over 9 months to recognize the public health crisis and to become personally involved in the issue.

If the White House wants to take ownership for its failures in dealing with H1N1, I’d welcome that honesty. We’re still in the middle of the crisis and, by acknowledging it’s many failures, the Obama Administration could really turn the tide in this crisis. But it takes a humble nature and a willingness to admit mistakes and a the kind of leadership to make changes – all have been lacking from the Obama Administration. It would seem that the White House is destined to make this crisis worse before it gets better.

Background: NPR

GSK Scores FDA Approval for Arzerra

noreply@blogger.com (_) — Tue, 27 Oct 2009 02:06:00 +0000

GlaxoSmithKline secured approval from the U.S. FDA for Arzerra (ofatumumab) for patients with a cancer of the blood and bone marrow called chronic lymphocytic leukemia (CLL) that is not controlled with traditional forms of chemotherapy. GSK’s development partner is Genmab A/S of Denmark. Arzerra is clinically similar to Rituxan, from Roche and Biogen Idec (BIIB).

Arzerra is a win for GSK from an agency that is becoming increasing more conservative and has had a tendency of changing protocols mid-trial on companies. The product was approved under the FDA’s special approval process that allows accelerated approval of drugs that have an unmet clinical need. Approval is based on a surrogate endpoint, but the company intends to submit additional data.

Healthcare System Wastes $800 billion; $200 billion in Fraud

noreply@blogger.com (_) — Tue, 27 Oct 2009 01:22:00 +0000

Here’s a riddle – what kind of healthcare reform is it when it doesn’t actually reform? It’s the kind being advocated by President Barack Obama and Senator Harry Reid.

Today, Reuters released a new report finding over $800 billion in waste in the U.S. healthcare system. Much of that waste President Obama hopes to cure with electronic medical records (EMRs). Surely health IT and EMRs will help here.

However, President Obama’s unwillingness to actually address the medical malpractice system is dooming all of his efforts to squeeze defensive medicine from the system (i.e., defensive medicine when physicians order unnecessary tests to evade malpractice claims). This is the real tragedy of healthcare reform. We have the opportunity to enact real, meaningful reform, but we won’t – the lobbyists for the trial lawyers are too deep in bed with Obama to allow for real change. (Remember that word – CHANGE?)

Even more concerning is the revelation that 1 dollar in 5 is outright fraud - $200 billion in criminal fraud. When was the last time you heard President Obama talk about going after dirty doctors that are committing criminal fraud? NEVER.

Here’s the real problem with healthcare reform – too many things are off the table. We can’t have meaningful healthcare reform while our President and Congress are too busy protecting their trial lawyer lobbyist friends and physicians who commit fraud.

We need real healthcare reform and that means putting everything on the table – including Obama’s trial lawyer friends. If Obama and Harry Reid aren’t willing to step up on meaningful reform, maybe we should be their legislation on the back burner until such time as they are willing to tackle fraud and malpractice.

Source: Reuters

No Watchful Waiting for Webber

noreply@blogger.com (_) — Mon, 26 Oct 2009 01:38:00 +0000

Sir Andrew Lloyd Webber has been diagnosed with early stage prostate cancer, his spokeswoman from the PR firm Brown Lloyd James. Webber is the British composer of numerous musicals, including “Cats,” “Phantom of the Opera,” the glorification of Nazi sympathizers in “Evita,” and everyone’s favorite snorer “Joseph and the Amazing Technicolor Dreamcoat,”

All the more shocking was the revelation that Andrew Lloyd Webber is actually being treated for his prostate cancer. Gasp! I can only imagine that the medical community is completely upset at Sir Webber’s refusal to engage in the treatment du jour: “watchful waiting.”

Here’s my feeling on “watchful waiting” for prostate cancer. Watchful waiting is gambling with your life. Sure, watchful waiting helps the NHS and Medicare in the U.S. save money, but you’re gambling your prostate cancer won’t metastasize and kill you. Is helping the government save money potentially worth your life?

Medically, I think Watchful Waiting has its place. But it is a limited place. Patients need to understand both the benefits and the risks of Watchful Waiting and they need to be given the choice to engage in Watchful Waiting…or in receiving treatment. That Prostate Cancer still kills over 30,000 men every year is a tragegy.

I’m not willing to tolerate 30,000 dead men in the U.S. (and another 10,000 in the UK) as acceptable collateral damage in the government’s cost control scheme.

Hospital-Acquired Infections

noreply@blogger.com (_) — Sun, 25 Oct 2009 17:24:00 +0000

Over 100,000 Americans die every year of hospital-acquired infections and countless others acquire infections that require significant additional treatment. These infections represent a nearly $7 billion burden to the U.S. healthcare system. And these infections are totally preventable. However, a recent article by Wachter, RM and Pronovost, PJ in the October 1 issue of the New England Journal of Medicine really struck me as insightful.

In hospital systems, we’ve intentionally designed a system of “no blame” around hospital-acquired infections. Physicians that slip up are held harmless – an incentive that was developed as a way to motivate physicians to adjust their behavior and employ sanitary hand Washington techniques. Essentially, “No Blame” was designed to minimize malpractice lawsuits.

However, the authors challenge the current hospital culture of “No Blame.” Perhaps it’s time to reintroduce a little accountability into the system where physicians are once again held accountable for their mistakes (including even basic errors like a refusal to wash their hands). Motivating behavior change necessitates both the carrot and the stick.

Industry has also responded. Kimberly-Clark has countered with an education campaign “Not on My Watch.” They offer products to dispense protective equipment and hand sanitizers found on many hospital floors. So, while physicians may be reluctant to embrace sanitary techniques, there are products that make it easier for docs – the Kimberly-Clark dispensing station does everything but wash doctors hands for them.

In the United States, we have the ability to eradicate hospital-acquired infections. There’s no reason why 100,000 people need to die. Hopefully, my physician peers will adjust their behavior soon.

H1N1 is a National Emergency, Obama sez

noreply@blogger.com (_) — Sat, 24 Oct 2009 20:14:00 +0000

Despite his slow response to the H1N1 crisis, President Barack Obama was able to take time out of campaigning for Jon Corzine and having his family portrait done by Annie Leibovitz to declare H1N1 a national emergency. While I think the CDC has done a good job managing H1N1 in the U.S. (not a great job, just a good job), they have been successful in spite of President Obama’s leadership.

The President’s announcement of a national emergency on H1N1 came on October 23. However, back on May 1, we all recall President Obama’s assessment that he didn’t think H1N1 would be any more severe than the normal influenza season. He did ask HHS Secretary Kathleen Sebelius to do a “worse-case scenario,” but his Administration was reluctant to recognize the true public health crisis early on and to execute the “worst-case scenario” plan.

The President’s lack of experience in public health and his delay in putting the full weight of his Administration behind this disease has lead to a delay in the H1N1 vaccine being fully available. Doubly concerning is the complete lack of planning at the Federal level for how the vaccine should be administered and distributed. President Obama has left it up to the States to figure out distribution – a move that has led to mass confusion and failures in some States.

Since President Obama’s first tentative steps, over 1,000 Americans have died and over 20,000 have been hospitalized by H1N1. There are full outbreaks in 46 of the 50 states. One thing is for certain, the death toll will continue to increase as the epidemic takes hold. While it’s better late than never, I’m glad President Obama is finally starting to take H1N1 seriously.

IMS Health Evaluates Options

noreply@blogger.com (_) — Sat, 24 Oct 2009 19:40:00 +0000

Since losing its legal battle on prescription information and physician secrecy, IMS Health has struggled. CEO David R. Carlucci has long-maintained that the financial fortunes of the company were de-coupled from the fate of the pharmaceutical industry, but that now appears to be nothing more than wishful thinking. IMS is in crisis.

The company took a 3Q loss due to a restructuring announced in July. The company lost $9.3 million in the quarter and saw revenues fall 6%.

More interesting was the announcement the company is evaluating “strategic options.” Wall Street has punished the company. Despite having repurchased millions of shares to prop up the stock price, the stock has been nearly stagnant over the last seven years. It was time for the Board of Directors to intervene.

Since the buyout was announced, the stock has jumped 20%.

Boys Need HPV Vaccine Too

noreply@blogger.com (_) — Mon, 19 Oct 2009 20:47:00 +0000

On Friday, Merck got the nod from the FDA for Gardasil in boys up to 26 years old for the prevention of genital warts caused by HPV. Of course, the added benefit comes to women when the men are vaccinated. Don’t you love herd immunity?

I’m kind of surprised it took this long, but I’m thankful it finally happened.

Ref: Merck Press Release

More Birthday Campaign Conflicts with Health Reform

noreply@blogger.com (_) — Mon, 19 Oct 2009 20:34:00 +0000

The American Cancer Society (ACS) has been running a More Birthdays campaign for a while. Unless you’ve lived in a hole, you’ve probably seen the TV commercials. Don’t get me started on why they would waste resources on a TV campaign instead of research, but they are. However, by treating and preventing cancer earlier, they are helping live longer lives – and celebrate more birthdays.

But more birthdays means longer lives – and more money spent on healthcare.

The ACS campaign on more birthdays is directly in conflict with the current policies of the Obama Administration. We have seen the White House put pressure on CMS to decline coverage of important cancer treatments and detection methods, such as virtual colonoscopy. These decisions are not taken because things like virtual colonoscopy are unsafe or ineffective. In fact the opposite is true – the sole reason the White House has become involved is because it will help colon cancer patients live longer.

This is a dangerous precedent in the United States – healthcare decisions made against the best interest of the patients and against the best medical evidence and solely on the basis of care rationing to keep costs down.

More Birthdays from the ACS is a strong statement in favor of human life. More Birthdays is about innovation – diagnosis and treatment. More Birthdays is about the personal struggle for survival in the face of healthcare system (public and private) that would rather see you dead.

Healthcare reform is about cuts to costs and care rationing. The government’s desire to control costs is in direct conflict with an individual’s desire to live. Whether you get your next birthday shouldn’t be up to a bunch of government administrators.

The Secrecy of Healthcare Reform

noreply@blogger.com (_) — Mon, 19 Oct 2009 02:30:00 +0000

Like nearly everyone in the healthcare industry, I’ve been frustrated by the cloak of secrecy surrounding all of the healthcare reform discussions. Despite his claims of openness and transparency, the Administration of President Barack Obama and the Democrats in Congress continue to discuss, debate and negotiate healthcare reform in total secrecy. As a citizen, if you want to read the actual healthcare reform bill – you can’t. The Obama Administration’s approach to healthcare reform is extremely similar to the Bush Administration’s approach to terror interrogations – you know it’s happening, you’re told not worry about it, but you can’t find out anything about it.

I found this petition from the Center for Health Transformation: Americans Have the Right to Know! Health reform should be discussed openly, honestly and civilly. On September 9, President Obama stood before a joint session of Congress and promised to debate his vision of healthcare reform on its merits.

I’ll be honest, I’m concerned about Obama’s vision for America. And I’m deeply troubled by his lack of leadership on healthcare reform (and the potential to make a tremendous mess of it). How many months has Obama been talking about it and we still can't actually read the bills? While I'm skeptical, I’m open to changing my mind. And I actually want a universal coverage system. By enacting legislation in the shadows, it makes me question whether President Obama is trustworthy or whether he is operating on behalf of special interest groups.

The time is right to have a civil discourse on healthcare reform. And that discourse begins with ALL Americans (not just Congressional Democrats) having the opportunity to review the bills before Congress.

Pfizer Closes Facilities; Protects Sacred Cows

noreply@blogger.com (_) — Sat, 17 Oct 2009 00:23:00 +0000

Pfizer’s deal to acquire Wyeth leaves it with a massive amount of real estate. Pfizer has decided to close certain Wyeth operations in Pennsylvania and New Jersey, while keeping Wyeth’s “corporate headquarters” building in Madison, NJ. More Wyeth sites could be closed in early 2010.

Sadly, for Pfizer shareholders, the company didn’t seriously consider shutting down its pricey executive digs on East 42nd Street in Manhattan. Ditto for the Wyeth facility in Madison, NJ. Pfizer has struggled in recent years and its management has made an impressive string of bad decisions. The company’s decision has been to dump cheap real estate in favor of more impressive, but less functional, property in Manhattan.

This is really about sacred cows. We’ve seen it from Pfizer in the past. As they’ve acquired Pharmacia and Warner-Lambert, Pfizer has created sacred cows and put certain things off limits – usually Pfizer’s management, Pfizer’s products and Pfizer’s locations. When you create a merger like this, you should put everything on the table and make the best decision possible.

Standard & Poor’s wasted no time in cutting Pfizer’s bond rating two notches from AAA to AA. Moody’s and Fitch both also cut Pfizer’s rating. In January, Pfizer cut its dividend to finance the Wyeth acquisition. There is considerable speculation that Pfizer will completely eliminate its dividend when the Pfizer board meets later this year.

Politics and the Failure of Public Health

noreply@blogger.com (_) — Fri, 16 Oct 2009 02:13:00 +0000

There are few functions in the healthcare industry as critical as the role played by public health professionals. The work done by the Centers for Disease Control and Prevention (CDC) and state health departments is essential…and under-appreciated.

However, I spent much of today scratching my head at the priorities of the CDC in dealing with public health emergencies. Chronic diseases are the single biggest health threat in America. Preventable, chronic disease is also the single biggest cost to the healthcare system. Fix the chronic disease problem and healthcare financial reform becomes almost irrelevant.

Unfortunately, the CDC isn’t focusing on chronic disease. The CDC is focusing on epidemic disease outbreaks like H1N1. Don’t get me wrong, H1N1 is a serious public health issue. However, it is not the ONLY public health issue, which seems to be how the CDC is acting these days.

So while 440,000 Americans die from smoking-related deaths every year, Dr. Thomas R. Frieden of the CDC is spending his time focusing on the less than 100 deaths from H1N1. This is a guy that did amazing things in New York City to enact smoking bans and promoting public health. So did he just get blinded by the celebrity status of his political appointment from President Barack Obama?

I’m not trying to be too critical of Dr. Fieden. I’m sure he’s a decent human being. However, when you have President Barack Obama serving as the Smoker in Chief, you have to wonder if political pressure is playing a role in the CDC’s lack of focus on tobacco and anti-smoking initiatives. It seems to be the only logical explanation.

This whole issue really hit home for me today with the results of a new Institute of Medicine report on second-hand smoking. The IOM found that in communities where smoking bans are enacted, there is an immediate and sustained reduction in heart attacks – in BOTH smokers and non-smokers. This is a tremendous finding and should bolster support for more smoking bans across the country. I’m thrilled that the IOM had the courage to complete this study in the current political environment.

This is an area calling out for CDC leadership – and leadership from Dr. Thomas Frieden. It’s my sincere hope that Dr. Frieden will remember his roots and take a more aggressive approach in fighting chronic disease in America.

Reference: Institute of Medicine

Europe Gets Dual Auto-immune Approvals

noreply@blogger.com (_) — Wed, 07 Oct 2009 01:16:00 +0000

The European Commission issued a pair of approvals for auto-immune conditions.

UCB nailed approval for Cimzia (certolizumab pegol), used for the treatment of patients with rheumatoid arthritis that have failed DMARDs and traditional therapy. Another option is always a good thing. (Ref: UCB press release)

Following closely, J&J (dba Centocor Ortho Biotech) and Schering-Plough (soon to be Merck) received approval for Simponi (golimumab) for the approval of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. (Ref: AP)

H1N1 Vaccine Arrives; Short Supply

noreply@blogger.com (_) — Fri, 02 Oct 2009 01:49:00 +0000

The CDC has taken possession of the first batch of H1N1 flu vaccines. Unfortunately, the supplies are extremely limited…for now. More doses will be coming soon, but that’s little consolation for those who want it now and can’t get it.

I’m fascinated to see how the CDC will handle the vaccine distribution and whether they can pull this off. There will be a lot of Monday-morning quarterbacking over the next few months.

GSK Files on Avodart

noreply@blogger.com (_) — Fri, 02 Oct 2009 00:58:00 +0000

After yesterday’s prostate cancer rant, I was pleased to see some good prostate cancer news from GlaxoSmithKline. GSK has filed a sNDA with the FDA for Avodart (dutasteride) reducing the risk of prostate cancer in men who are already at risk of developing prostate cancer. That’s good news.

However, given the FDA’s war on men and their refusal to help men with prostate cancer, I’m very cautious that GSK’s claim will be approved.

Reference: GSK press release

Prostate Cancer Pessimism in the Pepto-Pink Season

noreply@blogger.com (_) — Thu, 01 Oct 2009 00:36:00 +0000

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

noreply@blogger.com (_) — Wed, 30 Sep 2009 02:32:00 +0000

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

noreply@blogger.com (_) — Tue, 29 Sep 2009 02:20:00 +0000

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

noreply@blogger.com (_) — Mon, 28 Sep 2009 00:29:00 +0000

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

noreply@blogger.com (_) — Sun, 27 Sep 2009 21:42:00 +0000

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

noreply@blogger.com (_) — Sun, 27 Sep 2009 20:04:00 +0000

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.