Update on FDA Stories: Business as Usual

In my last two posts, I touched on some pretty significant FDA-related developments—and even though they’re barely a week old, a lot has happened since my commentary. Here’s a look at where things stand now. It’s not pretty.

The FDA, Avastin, and Wall Street

In a post last week, I urged the FDA not to approve Avastin for use with breast cancer patients, because (1) the science shows it’s not effective enough to warrant approval and (2) giving it the okay would set a precedent for approving mediocre drugs..

Naturally, the FDA approved Avastin at the end of last week.

In a comment quoted by MarketWatch, analysts called the FDA’s decision “a welcome outcome” because "investors and companies have expressed growing concern that the FDA's hurdle for approving drugs is a moving target and that a survival benefit is a necessity.”

But wait—just last week the Wall Street Journal noted that FDA “evaluation methods have remained largely unchanged over the last half-century.” In fact, the Journal cited this long-term consistency as emblematic of the agency’s “bureaucratic culture”—and yet here are the analysts, claiming that the problem is inconsistency.

Of course, the logic behind approval is a secondary concern to investors—what really matters is the financial consequences of an FDA decision. In this case the green light from the FDA sent Genentech shares shooting up by almost 10 percent in a single day. Predictably, financial analysts see big things in the company’s future: the investment bank Cowen & Co. forecasets  a peak potential sales estimate of $1.5 billion in 2012 and RBC Capital Markets analysts have upped their 2008 and 2009 sales forecasts by $17 million and $30 million respectively (the drug’s 2007 sales already clocked in at a whopping $2.7 billion).

This is indeed a welcome outcome—at least for Wall Street.

The FDA’s Capacity and Medical Devices

Earlier this week I commented on the Supreme Court’s medical device decision, arguing that—regardless of the legal arguments—a policy of preemption (i.e. when federal approval precludes future personal injury lawsuits) is wrong-headed because the FDA is in shambles. Its “approvals” are unlikely to be a truly reliable seal of safety.

Today in the Wall Street Journal (the paper is alternately enlightening and infuriating), FDA Commissioner Andrew von Eschenbach made clear that his agency was in fact hanging by a thread and needed “a systemic overhaul that must go on over a period of years.” He went on to say that “to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far.”

How many more dollars? Earlier this month in a congressional hearing, former FDA lawyer Peter Barton Hutt said that over the next two years, appropriations for the agency need to double and its staff must be increased by 50 percent. Eschenbach plays it a little closer to the vest, saying that he needs slightly more than a 2.95 percent increase in overall agency appropriations proposed in the president's 2009 budget. According to NewsInferno.com, this amount is $2.4 billion—which means that Eschenbach wants around another $72 million. Without such an injection of cash, the agency will only have enough to “barely cover scheduled pay raises and inflation.”

Meanwhile, today it was reported that a director of Medtronic (a medical device manufacturer) has completed “the largest stock purchase on record by an insider” at the company. Jack W. Shuler reported buying about $13.7 million in Medtronic stock (3.060 shares), “including some for his wife and some for trusts in the name of his children.” After this purchase was disclosed, “[Medtronic] President and Chief Executive William A. Hawkins and Chief Information Officer H. James Dallas also reported buying company shares.”

Why does this matter? Because Medtronic was the defendant in last week’s Supreme Court ruling. Two days before the Supreme Court decision, Medtronic profits plunged, largely because of costs associated with its legal woes. But now that the company has a guarantee of blanket immunity to personal injury lawsuits, insiders are looking to score big.

In sum, the FDA that has given in and is on its last legs as drug and device makers jump for joy over huge paydays. Surprising? Not really. Troubling? Very.

Comments

[generic viagra]

I personally really appreciate your work it has a lot of info for a new blog... i myself quite new in this field i once again say thanks for your great info

[E Cig]

Who cares what the FDA thinks, they just kill people with their bogus drugs.

[cheap levitra]

A heart attack is a medical emergency, and people experiencing chest pain are advised to alert their emergency medical services because prompt protection with an external defibrillator can save one's life from primary ventricular fibrillation which occurs unexpectedly in 10% of all myocardial infarctions especially during the first hours of symptoms. Contemporary treatment of many myocardial infarctions can result in survival and even good outcomes. While it is true that certain less amenable cases are very massive and rapidly fatal "widowmakers", it is also true that in small attacks with limited damage and optimal treatment the heart muscle can be salvaged.

[e cig]

I am beginning to really lose all faith and credibility in the FDA. It seems to me that instead of focusing their efforts on protecting the general public they are in-turn being influenced by corporate agenda and special interest. I take everything they say with a grain of salt.

[Gregory D. Pawelski]

Industry shills express the need of drug and medical device companies to be shielded from damages related to truly unforseen side effects of new drugs and devices. It is utterly impossible to anticipate and study every possible risk. It can take decades for certain effects to emerge.

On the other hand, if the company could be shown to have known about potential risks and then shown to have concealed them (like the tobacco companies did), then sic all the lawyers in the world on them and make them pay through the nose!

The effective anti-arthritis drugs (aspirin, indomethacin, ibuprofen, naproxen, etc.) all cause bleeding from the stomach (because they break down the mucosal barrier which protects the stomach from digesting itself).

Vioxx did address a problem for arthritis sufferers. Vioxx was supposed to be gentler on the stomach. But why trade arthritic pain for a heart attack?

[Jack Lohman]

What you should look at is the conflicts of interest on the Avastin panel. How many of the memers receive consulting fees from the manufacture of the drug?