None of this is quite as timely as it would have been 24 hours ago, but it’s worth giving my take on the new developments at FDA, and with the Cox-2s.

The news is that a new board within the FDA will oversee drug safety, and publicize more about its inner workings reviewing drug safety on the Internet. That’s all very well, although it’s not the announcement of an entirely new Federal agency to review post approval marketing and safety that some people might want. And of course it’s a role that will be subject to the FDA overall. The FDA will be led by an insider, Lester Crawford, who has been there all the while that the sky has been falling. THCB contributor Blunter is not alone in describing his appointment as a cop-out.

But it does appear that the FDA ostrich is lifting its head out of the sand. In today’s testimony on the Cox-2s, internal whistleblower David Graham revealed that he was given permission by Crawford to discuss unpublished studies and to give his full opinion. That marks a big change since his last testimony and it suggests that the FDA higher-ups realize that politically they can’t get away with their stonewalling.

It’s also good news that there are now promises to release more information earlier in the process. Part of the issue with the Cox-2s, particularly with Celebrex, is that the FDA (eventually) found out information about trials that it didn’t release to the public. The most pressing example of this is discussed by John Abramson in the excellent Overdosed America. Pfizer had basically hidden results of a 12 month Celebrex study from the FDA and only initially put forward the 6 month interim data. But while FDA got the new results eventually, it required a Freedom of Information Act request so that the public could discover what the FDA knew.

Now that the Cox-2 cat is out of the bag, there’s more and more bad news:

"A new study has linked pain killers Vioxx, Celebrex and Bextra to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs."

It’s not just the FDA and big pharma that comes out of this looking bad. The NEJM which published the original results doesn’t seem to be falling all over itself to eat crow. Abramson called them yesterday a "mouthpiece for the industry". The short comment from Jeff Drazen in the NEJM basically in a most understated way suggests that if just possibly Merck and Pfizer had conducted studies to investigate problems with the Cox-2s rather than new trials to get other indications, we might just have figured out the severity of those problems a little sooner. But nowhere is there a real admission from the NEJM that it either misrepresented the VIGOR results in its peer review process, or allowed itself to get conned by big pharma. In terms of further FDA reform, the slightly more aggressive piece also in NEJM by Psaty and Furberg notes that:

For an approved drug, the FDA currently engages in protracted negotiations with manufacturers rather than mandating manufacturers (1) to change a product label, (2) to conduct patient or physician education, (3) to limit advertising to patients or physicians, (4) to modify approved indications, (5) to restrict use to selected patients, (6) to complete post-marketing studies agreed on at the time of approval, (7) to conduct additional post-marketing studies or trials, and (8) to suspend marketing or immediately withdraw a drug. The FDA has recently claimed to lack adequate authority in these areas. We believe that to protect the health of the public, Congress needs to provide the FDA with the necessary authority and also to create an independent Center for Drug Safety with new authority and funding. Civil penalties should be commensurate with the scale of drug sales. Provisional approval and regular repeated review would provide opportunities to reevaluate risk and benefit. In addition, ongoing congressional oversight of the FDA would afford an important forum for the public discussion of drug safety.

But of course we’re probably not going that far anytime soon with the news out yesterday that the drug safety office will be staying within the FDA, which makes it unlikely to be quite as "independent" as all that.

And we’re never going to get to the rational debate about making more drugs available to more patients with everyone concerned having a real understanding of the potential risks and benefits involved. Which is a big pity because that’s what a grown up responsible FDA and medical system should be doing. I’m not convinced that Vioxx should, in a perfect world, be taken off the market. All drugs have some side effects and while Vioxx and Celebrex clearly shouldn’t be given out like candy, there may be patients where they work well with few side-effects and where they are a big improvement over NSAIDs. Theoretically the clinical trial data should be able to identify those patients, and patients on those products could be monitored for cardio-vascular risk, and taken off them if bad things start to happen.

But because the FDA didn’t do its job in the first place, and because the NEJM looked the other way, and because big pharma’s marketing machine ran roughshod over the minimal checks and balances in the system, we’re now in a mess which will likely see more good drugs not getting to market and the development of an overly-conservative approach to patient safety.

Perhaps integrating the use of drugs fully into the medical care delivery process might be a good place to start, rather than having the use of a prescription as a way for a doctor to get a patient out of their office. But that would require a whole new mind-set.

I was more than a little cynical about a speech from Fred Hassan of Schering a while back in which he suggested that everyone should put more money into their retirement accounts so that he could have more money in his. One would have thought that, with their stock prices tumbling, many of their products being pulled from the market and the public’s trust in their products and performance in dissarray, the CEOs of big pharma would be looking for a conciliatory approach. Instead here’s Eli Lilly CEO Sidney Taurel’s world view:

The nation’s health care system is ‘unhealthy to the core’ and soon will move from being chronically to critically ill if no changes are made. The principles of competition…… have become deformed in the health care field……Patients don’t see the true costs of health care because the government, their employers or insurance companies appear to be paying for them. Costs also are higher than they should be, Taurel believes, because the system is overregulated. "The free market hasn’t failed in the U.S.," Taurel will say. "It’s never been given a chance to work."

At least we agree on that last point. Basically Taurel says that he wants an unregulated system in which the consumer pays for everything out of pocket, and no doctor (or perhaps pharma company) is liable for anything they ever do. Funny that he didn’t seem to mention doing away with patent protection, but perhaps that’s not regulation in Indiana. Nor did he mention the teeny fact about how much money his company is going to make now that Medicare will be paying out for their products. Perhaps they just don’t know how their companies make money, although given the amount of money they spend on lobbying and corrupting PBMs and health plans, I suspect they do. Then it starts getting really funny.

Not every proposal would help the drug industry — at least not in the short term, Taurel says. Drug companies will feel as much pressure as the rest of the health care industry to cut costs. But Taurel says drug companies are better prepared to compete in that environment because they’re already feeling consumer pressure over drug prices and are trying to respond.

By putting up drug prices 5-10% since the election. That is a response, I suppose. But then comes the clincher:

"I’d much rather take my chances in a true, transparent, free-market system ruled by consumer choice than in a command and control system, driven by the winds of politics," Taurel says.

Now I’m rolling on the floor laughing my ass off. Pharma has made all its money in the last decade because of the increase in mostly private third party payment. Consumer payments went from being over 50% of all pharma spending in 1990 to less 32% in 2000. And pharma will make all its money in the next decade because of the increase in government third party payment. Payment that come courtesy of the Medicare Modernization Act that they bought and paid for! If you want to talk about the vagaries of politics consider that the director of the OMB and now new governor of Indiana is Mitch Daniels. What did he do before he went to DC? He worked for Tuarel at Lilly! The winds of politics are fine if you control the wind tunnel!

While I’m sitting here with my mouth gaping about the entire concept of this level of self-serving propaganda, The Industry Veteran has a rational explanation for the whole thing:

I suspect the Big Pharma CEOs are using some fairly simple mass communication principles beneath all their health care "reform" speeches. First, these braying donkeys command a forum. It’s amazing that the public immediately recognizes the mental vacuum accompanying the only other groups that attract such immediate media attention: Hollywood celebrities and professional athletes. CEOs of the top 500 companies maintain even greater access and control, but the public ignores their baldfaced self-interest and typical lack of expertise on subjects where they are venting blatant prejudices. At least there is the fascination of a novelty act in watching a bimbo starlet speak about wildlife conservation or dispossessed farmers. Our response to that phenomenon resembles watching a dog walk on its hind legs or turn the pages of a book with its left paw; we don’t expect it to be done well, as Samuel Johnson said, but feel a sense of patronizing amusement that it’s done at all. No such amusement accompanies a CEO’s pronouncements on public policy issues. As public spectacle it relies more on arousing latent, mass sadism, similar to the process of selecting a subject from the crowd for ritual slaying. At any rate, these thugs speak out on policy issues because they can and because they feel they can influence the outcome in their favor.

Secondly, the Taurels, Hassans, McKinnells, Garniers and McKillops have started to broadcast their plutocratic preferences more widely within the last few years because they are slipstreaming behind George Bush’s strategy of promoting the Big Lie. Not many years ago a person would have been considered delusional after publicly announcing that individuals can more effectively provide insurance safety nets for their retirements than the Social Security system. Custodians of public safety would really have called for the thorazine and restraints if the same person also proclaimed that unconscionable tax breaks for the wealthy make the entire country more productive. When Barry Goldwater made similar assertions in 1964, a number of psychiatrists questioned his emotional competence to serve as president. In past years good burghers might have even stormed the White House/Frankenstein laboratory with flaming pickets if its self-same occupant also started a preemptive war using entirely phony reasons. Alas George W. Bush faced neither angry mobs nor a padded room. Instead thoughtful imbeciles pondered whether the Almighty transmitted His unseen wisdom to the W more or less accurately than a contradictory message He sent to Pat Robertson. So in a society that now constitutes Stanley Milgram‘s laboratory writ large, by virtue of its blind obedience to authority, Big Pharma’s capi di regime figure they might as well trot out their avuncular acts. Why settle for one sucker a minute when a simplified message, repeated frequently in the mass media, can create millions?

As a third reason for this pathetic roadshow, the Big Pharma CEOs would not agree with your assumption that the public despises them. Improbable as it may seem, their batallions of sycophants and courtiers successfully insulate them from reality. As a result of such fantasyworld thinking, J.P. Garnier demanded that GlaxoSmithKline’s board double his salary despite the company’s abject failure at drug development under his leadership. Similarly, AstraZeneca’s Tom McKillop asserted his demand for one million pounds added yearly compensation, despite failures such as Exanta, Crestor and Iressa that substantially lowered share prices. I could continue at monograph length along such lines. Suffice it to say that Pharma’s CEOs do not accept public perceptions of their villainy. They actually think of themselves as benevolent, pragmatic, shrewd businessmen who are wrongly villified by a sensationalist press and political opportunists that seek scapegoats for an over-regulated, unworkable system. To change public perceptions, they have adopted Big Tobacco’s PR strategy. In 2004 Astrazeneca actually hired as its VP for US public affairs a fellow who spent his previous 12 years working for Philip Morris, now called The Altria Group. Under his direction their PR posture has been one of swift, hardball responses and preemptive attacks upon critics such as Public Citizen and Marcia Angell. In the UK, meanwhile, Astrazeneca arranged for The Scotsman to run a puff piece on Tom McKillop that makes him appear more a combination of Albert Schweitzer and Johnny Carson than the Celtic barbarian he is.

So there you have it. The heads of Big Pharma have the forum, they want to push the Big Lie, they actually think they’re nice guys, and they’ll use every dirty trick to shove that idea down our throats and make us believe it.

It all reminds me a little of when Nicolae Ceausescu was dictator of Rumania and his thugs would arrange cheering crowds and full shops on the streets when he drove around Bucharest. One day he flew back from a foreign trip early and they didn’t know he was coming. He was amazed to see lines of pissed-off people queueing outside empty shops. Of course, it didn’t stop him from ending up against the wall with an over-abundance of volunteers for his firing squad.

And in today’s cheap shot Viagra post…

Apparently the main ingredient in Viagra is showing potential for reducing the chance of some heart diseases. In mice it’s been shown to "reverse the growth associated with heart failure, a chronic heart condition caused by infections, high blood pressure and other heart diseases." I assume that it works by the blood causing the growth of the heart being diverted elsewhere….

The NY Times has an article which essentially forecasts the demise of Merck. Other bloggers here at THCB, over at Business Word and at In The Pipeline have all written various versions of the same story but none of us have been quite as upset as the NY Times about the impact on the economics of flower shops in New Jersey.

Andy Borowitz’s daily Borowitz report is the funniest thing in my in-box. And never a truer word was said about the real capability of pharma DTC to change the world than today’s report which I reprint below.

CIA ATTACKS AL-QAEDA WITH PRESCRIPTION DRUGS Secret Weapon in War on Terror

The Central Intelligence Agency has implemented a new plan to destroy the al-Qaeda terror network by convincing the terrorists to start taking hazardous prescription drugs, the agency confirmed today. Within the intelligence community, hopes are high that evildoers will begin taking the medications and will soon afterwards suffer from a broad range of serious side effects, including heart attacks and death.

According to one CIA source, agency analysts developed the prescription drug strategy after they viewed a video of al-Qaeda leader Osama bin Laden walking in mountainous terrain and noticed that he seemed to be experiencing "a certain degree of joint pain."

The source said that on Monday of this week the agency launched a multimillion-dollar marketing campaign aimed at terrorists and madmen around the world, urging them to start taking several recently discredited pharmaceuticals. In one commercial currently airing on the Arabic-language al-Jazeera network, an actor portraying a terrorist says, "I was in so much pain, I just didn’t feel like going on jihad anymore."

After praising a prescription arthritis medication, however, the same evildoer is seen jumping through an obstacle course at a terror training camp, saying, "Now I wake up every morning ready to kill the infidels!" According to the CIA source, prescription drugs may be the secret weapon that the spy agency has long been looking for to win the war on terror: "The bad guys may have Anthrax, but we have Vioxx."

Elsewhere, a Colorado man who said he was optimistic about the upcoming Iraqi elections later discovered that he had a four-inch nail lodged in his skull.

On Friday I commented on the proposal to withdraw liability from punitive damages from pharma products approved by the FDA, and (probably vainly) appealed to responsible people in pharma-land to take at least look this gift horse closely in the mouth. The Industry Veteran was not hopeful and ascribes my perspective of naivete to my place of nativity. He writes:

The perfidious Albion shows through your plaintive call for some responsible, intelligent action from Big Pharma. You wanly hope for the industry’s Wise Men to tell their CEO peers that current policies will create a devastating backlash. The fact is, Matthew, in American industry there is no House of Lords or even a council of seasoned gentrymen to provide rational thinking and responsible, adult behavior. The fiduciary officers who run the Big Pharma companies each seek to compile a stash of +/- $100 million in a fairly short period of time and then get out while they’re still young enough to enjoy these ill gotten gains. As a result, their thinking is focused entirely on the near term and contains not a whit of concern for the industry’s long-term survival. Given that they’re indifferent to the well being of their employees, customers and, for the most part, their shareholders, it is at best naive to hope that they would value something as nebulous as a legacy. Your call for the emergence of Pharma Wise Men is as much as cry of despair and an admission of spent thinking as the bedraggled Democrats who expect a more moderate George Bush to appear during the second term because he may want to establish a legacy.

A few months ago I had a similar conversation with an acquaintance who retired from Bristol-Myers Squibb. I expressed my view about the narrow, self-serving approaches of Pharma management.

"I said the same thing to Charlie Heimbold," he told me, referring to the previous chairman of BMS. "When I mentioned the $100 million figure, Charlie stopped dead in his tracks as we were walking down the hallway and said, ‘Is that all they’re looking to get? They ought to be fired for not being ambitious enough!’"

I responded by asking how much Heimbold took with him when he retired. "It was easily $500 million," said the confidant.

A quick trawl of the blogs this morning finds me catching up on an excellent article on the present and future of DTC from John Mack at the Pharma Marketing Blog, and discovering a new anti-pharma blog called Pharmopoly. Obviously take this with a pinch of salt but here is what the anti-globalization folks at Pharmopoly are saying, and note that drug companies are now moving squrely into their cross-hairs over patnets and reimportation as well as over thrid world imports:

Continue reading…