Tiwanaku Alien and the News Media

A standard false impression among many individuals is that the news media, together with newspapers, radio, and TV, is honest and goal and can report to them something and every thing that they need to know about. Nothing may very well be farther from the truth. The fact is that it takes a number of cash to personal a news media entity, that's to say, their homeowners are rich, and, naturally, wealthy folks hire journalists and newscasters who support their interests.

The interests of the rich embody implementation and maintenance of a steady surroundings the place they pay little or no taxes and thus get richer. For whatever motive, and maybe rightly, aliens -clever beings from other planets- are and have at all times been perceived as the greatest risk to that stable environment. Thus, it isn't shocking that the media has turned their propaganda machine towards aliens. For a lot of a long time now, the public has been often bombarded with each quack (simply falsifiable or unprovable) principle there is about aliens, including fairly a few UFO pictures and abduction stories, all in an effort to fully discredit aliens. In the meantime, genuinely strong arguments for aliens, like the Tiwanaku drawings of an aquatic creature inside a helmeted spacesuit, will never see the light of day in any media outlet.

Aliens have been so closely discredited by the media that the present outlook for them is bleak. Certainly, the state of affairs is now so unhealthy that a large alien spacecraft may come to rest a few toes above the White House and it is perhaps efficiently explained away as a secret experiment to guard the president. It appears nothing could be performed to convince anybody that aliens exist. Even the scientific group has been engulfed by the media blitz. Thus, no archaeologist is prone to ever express what he would possibly assume: Hey, those Tiwanaku drawing actually do appear to be an alien, plus they explain the Nazca Lines. Such a remark might result in the fast termination of an archaeology career.

While aliens stay public enemy number 1, they aren't perceived as the only threat to low taxation rates for the rich. In my nation, the United States, for example, one other menace comes by means of politicians who're open to tax increases, and the media has turned their wrath towards them as well. Thus, within the congressional elections of 2010, we discover that the nation's elderly and poor flocked to the polls by the millions to vote for politicians that promised to denationalise social safety, to cut Medicare advantages and well being care programs, to chop food stamps, and to scale back unemployment advantages and each different type of benefit for the less fortunate, all for the purpose of helping to pay for continued and expanded tax reductions for the nation's billionaires.

I am certain the aged and poor of that country will tell you that they used their judgment in making their voting decisions and can by no means admit to being duped. The brainwashing methods employed by the media are extraordinarily delicate and it takes an skilled to detect them. I gives you an example. In an uncommon (very rare) event that I was exposed to TV final 12 months, I noticed that a major information network was operating the next poll: Do you imagine that Barrack Obama is the Antichrist? In fact, an accountable and respectable nationwide news community has no enterprise running a ballot like that especially contemplating that there is no such thing as a laborious proof that the Antichrist is alive in contemporary occasions not to mention it being the duly elected president of the United States. In any case, with countless millions of Individuals overtly declaring their president to be the Antichrist, from where it follows that his supporters in Congress (members of his political celebration) are all demons, it is simple to see why the aged and poor voted for politicians who promised to do them harm.

In historical instances and later it was kings and queens versus servants, in medieval instances it was feudal lords versus fiefs, in Russia it was landlords versus serfs, in American it was slave house owners versus slaves, and in modern instances it is known as wealthy versus poor. Hundreds of years of human historical past have passed by however there was no fundamental change in human inclinations to dominate and management other humans. Only contact with aliens would possibly alter these inclinations.

Morten St. George is the author of various articles within the Tiwanaku Alien sequence and the creator of a website about Ancient Astronauts.

Tiwanaku Alien and the News Media

A standard false impression among many individuals is that the news media, together with newspapers, radio, and TV, is honest and goal and can report to them something and every thing that they need to know about. Nothing may very well be farther from the truth. The fact is that it takes a number of cash to personal a news media entity, that's to say, their homeowners are rich, and, naturally, wealthy folks hire journalists and newscasters who support their interests.

The interests of the rich embody implementation and maintenance of a steady surroundings the place they pay little or no taxes and thus get richer. For whatever motive, and maybe rightly, aliens -clever beings from other planets- are and have at all times been perceived as the greatest risk to that stable environment. Thus, it isn't shocking that the media has turned their propaganda machine towards aliens. For a lot of a long time now, the public has been often bombarded with each quack (simply falsifiable or unprovable) principle there is about aliens, including fairly a few UFO pictures and abduction stories, all in an effort to fully discredit aliens. In the meantime, genuinely strong arguments for aliens, like the Tiwanaku drawings of an aquatic creature inside a helmeted spacesuit, will never see the light of day in any media outlet.

Aliens have been so closely discredited by the media that the present outlook for them is bleak. Certainly, the state of affairs is now so unhealthy that a large alien spacecraft may come to rest a few toes above the White House and it is perhaps efficiently explained away as a secret experiment to guard the president. It appears nothing could be performed to convince anybody that aliens exist. Even the scientific group has been engulfed by the media blitz. Thus, no archaeologist is prone to ever express what he would possibly assume: Hey, those Tiwanaku drawing actually do appear to be an alien, plus they explain the Nazca Lines. Such a remark might result in the fast termination of an archaeology career.

While aliens stay public enemy number 1, they aren't perceived as the only threat to low taxation rates for the rich. In my nation, the United States, for example, one other menace comes by means of politicians who're open to tax increases, and the media has turned their wrath towards them as well. Thus, within the congressional elections of 2010, we discover that the nation's elderly and poor flocked to the polls by the millions to vote for politicians that promised to denationalise social safety, to cut Medicare advantages and well being care programs, to chop food stamps, and to scale back unemployment advantages and each different type of benefit for the less fortunate, all for the purpose of helping to pay for continued and expanded tax reductions for the nation's billionaires.

I am certain the aged and poor of that country will tell you that they used their judgment in making their voting decisions and can by no means admit to being duped. The brainwashing methods employed by the media are extraordinarily delicate and it takes an skilled to detect them. I gives you an example. In an uncommon (very rare) event that I was exposed to TV final 12 months, I noticed that a major information network was operating the next poll: Do you imagine that Barrack Obama is the Antichrist? In fact, an accountable and respectable nationwide news community has no enterprise running a ballot like that especially contemplating that there is no such thing as a laborious proof that the Antichrist is alive in contemporary occasions not to mention it being the duly elected president of the United States. In any case, with countless millions of Individuals overtly declaring their president to be the Antichrist, from where it follows that his supporters in Congress (members of his political celebration) are all demons, it is simple to see why the aged and poor voted for politicians who promised to do them harm.

In historical instances and later it was kings and queens versus servants, in medieval instances it was feudal lords versus fiefs, in Russia it was landlords versus serfs, in American it was slave house owners versus slaves, and in modern instances it is known as wealthy versus poor. Hundreds of years of human historical past have passed by however there was no fundamental change in human inclinations to dominate and management other humans. Only contact with aliens would possibly alter these inclinations.

Morten St. George is the author of various articles within the Tiwanaku Alien sequence and the creator of a website about Ancient Astronauts.

Financings of the Fortnight’s Pot Luck Supper vs Food for Thought from Tauzin and Kindler

This week we’ve got a little bit of everything out there for you FOTFanatics. Corporate Venture? Of course. Meaty FOPO? You got it. Odd restructuring? Why not. Sexy SEDA? Your wish is our command. And unlike last fortnight’s Eurolicious entourage, this week we feature some All-American talent. And a Canadian.

These guys--and their investors--obviously didn’t get the memo from PhRMA honcho Billy Tauzin and Pfizer CEO Jeff Kindle, who spent their podium time at yesterday’s Partnering For Cures meeting publicly worrying about the state of the States’ hospitality to the biopharma industry.

Tauzin woke us up as he railed at the state of the Food and Drug Administration, noting the regulator was no longer the premier drug agency in the world (that’d be EMEA, if you’re wondering); FDA didn’t take all the blame of course, to Tauzin some of its ineptitude was the fault of Congressional indifference. Meanwhile, someone please buy Margaret Hamburg and co. a DVD player, or maybe a TiVo?

"12:00 is blinking on a VCR at FDA, they are that far behind technologically," observed Tauzin. (No word on whether FDAers were sporting neon leg warmers while listening to Whitesnake while wearing out their Betamax copy of Top Gun on said VCR, but that’s what we were thinking.)

[NOTE: Keep your eyes peeled for coverage out of Windhover's ongoing FDA/CMS Summit in Washington, where FDA's John Jenkins just coincidentally unpacked and disputed the argument that FDA is more 'conservative' than EMEA.]

Other panelists at the breakfast session walked back the criticism. Bob Beall, president and CEO of the Cystic Fibrosis Foundation, commended FDA for its progress in clinical trials in the rare diseases space, noting that any path forward with the agency should begin with direct dialogue and not with confrontation, and not with Congress passing laws to tell it what to do.

And the earlier that dialogue begins, the better. With regards to personalized medicine, for example, he noted that a company can’t wait ‘til Phase III, or even IND stage, to start a discussion about biomarkers. He did lament the status of inter-agency harmonization between EMEA and FDA, but in the end with a wave in Tauzin’s direction said “I’m optimistic about the FDA.”

Founder and CEO of the Multiple Myeloma Research Foundation Kathy Giusti agreed with Beall. FDA, she said, had been “phenomenal.” And using an age-old technique she later suggested if only foundations could get academic and industry attorneys on the same page with contract language “we can all start using,” things would be so much better. As with most remarks that blame the lawyers, those words received a round of applause.

But in any case we shouldn’t be surprised when everyone relocates to Singapore, seemed to be part of the message from Tauzin. That’s something Pfizer’s Jeff Kindler alluded to as well.

During Partnering for Cures' lunch-time session, Kindler, fresh off the “pharma needs to own up to its mistakes to regain public trust” circuit of interviews and talks, sat down with FasterCures founder Michael Milken to discuss Pfizer’s attempts to shorten the timeframe of the drug discovery-development continuum.

Along the way he discussed some of Pfizer’s impressive feats—the creation of HIV specialist ViiV Health Care with competitor GSK, for example, or this week’s deal with Israeli biotech Protalix for its Gaucher’s disease treatment (we’ll leave it til tomorrow’s Deals of the Week to get in-depth on that one).

But he repeatedly invoked the strides made in emerging markets and industry hubs like China and Singapore to speed up clinical trial recruitment, for example. We in the US “have to be mindful of the fact that there are a lot of advances being made in other countries that are very interested in having those clinical trials done there, and that’s where a lot of innovation is going to occur. I think that’s where the big opportunity for speeding up bringing medicines to patients is.”

He later noted that governments in some emerging markets “are very ambitious and aggressive” in beginning to meet the unmet medical needs of their populations and “in encouraging innovation and research and providing incentives for companies like ourselves to locate manufacturing, research and clinical trials in those countries.” In case the message wasn’t clear he added: “And are doing so I might add in many cases with a coherent government/business collaboration that quite candidly we’re not seeing as much of in the United States as we’d like.”

He went on to talk about how China has headhunted Chinese-born young, ambitious, and eager scientists based in the US and elsewhere to return and set up shop in places like Shanghai’s Zhangjiang Park and elsewhere. This migration is “something we need to take account of as US policies are adopted that can have an impact on our ability to support what I consider to be a very important American industry,” he said.

Read more about Kindler’s remarks in today’s Pink Sheet DAILY (and for more on Pfizer's activity in China, see this IN VIVO feature). Then fly the flag for the companies below, this fortnight’s fancy financing phenomena. It’s …


Forma Therapeutics: It’s not that often you see a start-up raise more than $50 million in venture capital and pen two notable alliances with pharma companies within one year, but Forma Therapeutics has managed to do just that. The biotech—which according to this recent profile in START-UP may be onto a winner with its combination of structure-guided cancer drug discovery and proprietary cell-based screening capabilities—pulled in $25.5 million through a Series B financing led by Lilly Ventures (more corporate venture!), announced on December 1. Also participating were Novartis Option Fund and Bio*One Capital, investors in Forma’s January 2009 $25 million Series A. Forma has deals with Novartis (in oncology, signed shortly after it’s A round) and Cubist Pharmaceuticals (antibacterials). The latter deal included a note that converted into stock in the current Series B.—Amanda Micklus

Receptos: The $25 million Series A financing for newly formed Receptos is not as simple as it first appears. The San Diego firm targets GPCRs and described its initial financing as a two-tranche deal, $17 million now, maybe $8 million later. The full story is that Receptos purchased Apoptos, which had raised $28 million in its own relatively recent Series A in January 2008 (so it's more of a reinvention). Roughly $5 million left from that financing was included as part of the first tranche of Receptos’ round – along with $12 million from the company’s venture backers, explained Jim Schmidt, VP of finance and administration. Receptos can qualify to receive the second tranche of $8 million upon the filing of an IND for its lead candidate – a sphingosine-1-phosphate receptor candidate for multiple sclerosis. That filing is expected by the fourth quarter of 2010, says Chrysa Mineo, VP of corporate development. Participants in the new round were Venrock, ARCH Venture Partners, Flagship Ventures and Lilly Ventures. (There’s that corporate venture again!) Each of those funds received a seat on the Receptos board, with Venrock’s representative, former Biogen Idec Executive Chairman William Rastetter, serving as CEO and chairman.—Joseph Haas

Vertex Pharmaceuticals: According to Elsevier’s Strategic Transactions database, follow-on public offerings have increased substantially from a low of $3 million in the fourth quarter of 2008 all the way up to $1.6 billion in the third quarter of this year. While final fourth quarter numbers are not yet available, it looks to be on pace to beat Q3 thanks to a few big FOPOs completed this fortnight by Salix Pharmaceuticals ($128 million), Human Genome Sciences ($415 million), and namely yesterday’s $442.8 million stock sale by Vertex Pharmaceuticals. The small-molecule drug developer, which focuses on several therapeutic areas including infectious diseases, offered 11.5 million shares at $38.50, a price on par with what the company has been trading at for the past few weeks. The stock jumped 8% to $36.15 on November 2--and has been gradually increasing since then into the high $30s/low $40s--following news that 83% of HCV patients in each arm of Vertex’s C208 study had achieved a sustained-viral response with twice-daily telaprevir. Vertex is planning an NDA for the HCV protease inhibitor in the second half of 2010. Less than two months ago, the company monetized future European milestones it would have gotten from telaprevir partner Janssen in a deal with four investment funds, which bought $120 million in Vertex convertible debt and paid another $35 million cash in exchange for $250 million in regulatory and launch milestones. Earlier this year, Vertex completed another huge follow-on offering, which netted $314 million. Since 2008, the company has raised $1.4 billion through four FOPOs.--AM

Labopharm: The public markets are slowly warming to biotech—note Vertex and HGSI’s monster $400 million public offerings, UCB’s €500mm bond offering and Movetis’s announcement that it closed its IPO, bringing in €85m (with the overallotment yet to be determined). But for many of the smaller players capital is still a scarcity, making alternate financing arrangements like Labopharm’s $25 million standby equity distribution agreement (add SEDA to your bin of acronyms to name drop this holiday season) with Yorkville Advisors, an attractive prospect. Under the terms of the agreement, YA will provide up to $25 million during the next three years, available at Labopharm’s discretion via the purchase of new shares, issued at a predetermined discount (that maxes at 5%) to the prevailing stock price. In addition, limits prevent YA from owning more than 19.9% of Labopharm’s issued and outstanding common shares at any one time. The control offered by the SEDA—in addition to the biotech determining when to pull the trigger, it also determines the amount to draw down, with a built-in minimum price—is clearly attractive to smaller biotechs or specialty pharmas who might have cash-generating milestones on the horizon while simultaneously lacking the in-house resources to reach those events. The Quebec, Canada-based Labopharm fits the bill. The company had just over $14 million in cash and cash equivalents at the end of its third quarter, as well as roughly $21 million in long term debt payable starting in 2012. In addition, the company is preparing for the 2011 launch of its second product, DDS-04A, which is a once daily-formulation of the serotonin antagonist reuptake inhibitor traszadone that is currently awaiting a regulatory decision from FDA. In the SEDA-world (it’s not an obscure planet in a galaxy far, far, away) Yorkville has been an active player. This year alone, the company has inked SEDAs with Advanced Life Sciences, RXI Pharmaceuticals, Pharming, and Achillion. –Ellen Foster Licking

image from flickr user Jamie Anderson used under a creative commons license.

Julie Brill Nominated to FTC: A Message to Drug Manufacturers?

The Obama administration may have sent a subtle message to drug manufacturers Monday, when it nominated Julie Brill to be one of two new commissioners at the Federal Trade Commission. The message? Make sure your marketing practices don’t collide with consumers’ best interests.

Brill has overseen consumer protection for states since 1988, with a major emphasis on watching over the pharmaceutical industry. She spent most of that time (1988 until February 2009) in Vermont, as assistant attorney general, when the state became an epicenter for cracking down on drug marketing practices.

You’re familiar with Vermont’s public disclosure of manufacturer payments and gifts to physicians? Yep, Brill was behind that. How about the law cracking down on using physician prescribing data for marketing purposes? That was one of hers too.

And there were those big settlements with PBMs, when they were accused of switching patients’ prescriptions for their own financial advantage. Brill was an important driver behind that deal. Interestingly, FTC very recently opened an investigation into the practices of one of the biggest PBMs, CVS Caremark, and how they impact consumers (see “The Pink Sheet” coverage of this investigation here).

Of course, Brill has other interests – privacy and antitrust issues are big ones – but as a commissioner, she’ll have a big say in what practices get investigated.

She still needs to be confirmed by the Senate, and the process will involve a hearing before the Commerce Committee, which is chaired by Sen. Rockefeller, not one known for his kind words about the pharmaceutical industry. It will be interesting to see how much of that hearing will focus on her pharma-related activities (see more about Julie Brill here in “The Pink Sheet” DAILY).

Big Pharma ISO Big Democrat: Who Will Pfizer Land?

If you walk by Pfizer’s Manhattan headquarters, you might spot a “Help Wanted” sign in the window. Something like “World’s Largest Pharma Co Seeks Big Name Democrat to Shape Policy in Era of Health Reform. Contact: J.Kindler.”

As we reported here, Pfizer is revamping its government affairs group to align better with the Obama Administration. Its first recruit is transition team member Greg Simon.

That’s a great hire, but the company wants to land a really big name Democrat to head its public policy and government affairs operation. And we mean big. After all, it’s a big job. Really big. Pfizer is already the world’s biggest pharmaceutical company, and it keeps getting bigger. And the policy stakes are big. Health care reform big. And, no matter how the reform debate turns out, the role of government in driving pharmaceutical markets will be bigger too.

There’s just one big problem: every leading Democratic political figure wants to be part of health care reform, so its not like there’s lots of big names available for Pfizer to hire.

Gee, if only they’d done this when the Republicans were in charge they could have had anyone they wanted….

Okay, that would have been suicidal. In fact, we have to give Pfizer credit. Their last “big name” policy hire, Tony Principi, was not only a former cabinet secretary in the Bush White House, he reached retirement age at the end of the Bush Administration. (He turned 65 in April). No need for a messy separation on Inauguration Day!

So far, we’ve heard only two candidates for the Pfizer job: Former House Majority Leader Dick Gephardt (picture below) and former White House Press Secretary Michael McCurry.

Those are two strong candidates. Gephardt ran for President twice, (even though he got fewer votes than Pfizer has employees), and he remains a nationally known figure. He certainly seems interested, having teamed up with the Pharmaceutical Research & Manufacturers of America to promote innovation in health care reform via the Council for American Medical Innovation-though we're not sure the made-in-the-USA theme is the best fit for Pfizer's emerging markets strategy.

McCurry never held elected office, but he has more than three decades of experience as a political operative and would bring great contacts with the Democratic establishment. Like Gephardt, he has engaged with PhRMA, offering advice on dealing with the industry’s chronically poor public image. (Read more here.)

So Pfizer would probably do well to land either of those two.

But, come on, there have to be more possibilities right? Here’s a few to get you thinking—and please give us your suggestions as well.

Tom Daschle would be an obvious choice, so obvious that we assume he must have said no already or he would be on the list of candidates we heard about.

Bill Clinton is the biggest name out there, and if his wife weren’t the Secretary of State, we’d be prepared to make the case that he is exactly the person for Pfizer to go after. But she is, so we won’t.

Jimmy Carter’s a non-starter. Too old. Plus he’d laugh in Pfizer’s face.

Al Gore? Interesting…he’s probably tired of looking at the Nobel Prize and Oscar Statuette display by now.

Actually, when it comes to Tennessee politicians, Harold Ford would be a great choice. The only hitch: everyone thinks he has a bright future ahead of him in politics, so why give that up now?

That’s it! Eliot Spitzer! He’s available, and he’s local.

Smoke Signals Look Good for Biopharma

The smokeless backrooms of politics in Washington 2009 are looking like a good environment for the biopharma industry -- better even than the deals that emerged from the smoke-filled rooms of lore.

This could very easily have been a year of multiple political threats to the industry with the drug business portrayed as a scapegoat for out-of-control health costs, but it is emerging instead as a year offering reasonable compromises and proposals to protect pharma pricing and give the industry access to significant new markets.

The first signs that the biopharma sector may have crawled out of the bulls-eye as a target for health reform are (1) the Obama Administration's decision to turn back to the tobacco industry as the number one health villain and (2) relatively small financial contributions expected from the biopharma sector to pay for health care reform.

As we have written recently, tobacco regulation is next on Capitol Hill agenda for the Democrats. Getting rid of cigarette smoke has become a core issue for the new administration despite the fires incinerating the other parts of the economy. The campaign against smoking is more accurately a "Corr" issue for the administration, supported by the HHS Deputy Secretary-designate, William Corr, a long-time ally of House Energy & Commerce Chairman Henry Waxman (D-CA) and long-time critic of the tobacco industry.

No matter how the anti-smoking campaign found its way into the packed Obama agenda, the fact that it is there means that pharma immediately becomes a lesser evil on the list of industries affecting US health care.

Pharma is well aware of the smoke-screen and regulatory/political cover that the tobacco industry presents. Even before the 2009 legislative season was underway, Pharmaceutical Research & Manufacturers of America President Billy Tauzin was expressing full support for the government to go aggressively after tobacco regulation.

"Any work" the government could do "to prevent people from smoking is good work," Tauzin declared, saying "tobacco is not our friend." It is a point not lost on a political pro like former House Energy & Commerce Chairman Tauzin that pharma experienced its best years of growth and new product introductions while the Food & Drug Administration was absorbed in its fight against the tobacco companies in the late 1990's.

The anti-smoking position allows Tauzin to talk positively about health reform. He took his prevention rhetoric to the White House Summit where he talked about the importance of healthier lifestyles. He claimed that 67 percent of cancers could be avoided if people did not smoke, ate properly and exercised.

Tobacco regulation can be a distraction for FDA's senior management and take up a lot of the agency's resources, but it creates a less pressured atmosphere for drug regulation.

The second sign of a developing positive atmosphere for biopharma is the relatively small $29 billion that the industry will be expected to contribute to the $634 billion down payment fund for Obama's health care reform initiative. That is the amount the federal government will collect from increased Medicaid rebates. Pharma will actually face additional payments to the states of about $12 billion more (for a total of $41 billion). The full negative impact on the industry including cost reductions in the private market is estimated at $70 billion over ten years.

Compare that to $117 billion that the health insurers are being asked to give up from reductions to Medicare Advantage payment rates and you can see why the health insurers are crying "foul" and complaining that the pain of health reform is falling disproportionately on them. It also becomes clearer why biopharma leaders are accepting the proposed payments more stoically: they are being asked for less and have a lot to gain if insurance coverage can be more widely extended to the currently uninsured and under-insured -- a potentially large new market for pharmaceuticals.

The fact that cuts to pharma revenues are within the tolerable range combines with the industry's position against smoking to create a good climate for working with the White House, HHS and Congress on two key industry objectives: (1) a well-crafted follow-on biologics bill and (2) control over patient co-pay levels for drugs and biologics.

By supporting Corr's anti-smoking effort, pharma improves it relationship with a key figure for the FOBs bill. Corr was the staff architect for Waxman behind the original Waxman-Hatch generics bill 25 years ago. He is likely to be the driving force behind getting a follow-on deal done this year. He is no friend of pharma; but having the smoking issue as background is very convenient for the industry.

Legislative control over co-pays is getting less public attention but could be the big money issue for pharma in the current legislative season -- especially as specialty drugs and biologics become more important to the industry.

Both BIO and PhRMA have identified efforts to restrict the amount of out-of-pocket expenditures that patients will have to make for drugs as important to their policy agendas. This is an access issue for patients that offers an indirect price protection to the industry. If pharma can avoid high co-pays, that will permit them more flexibility for high prices.

The objective is to make sure that health insurers and Part D Medicare plans cannot set co-pay levels so high as to act as a de facto barrier against patient use of the products. The drug industry senses that controls on co-pays are politically viable in a Democratically-controlled Washington because they can be presented as a patient/beneficiary access issue.

The Democratic victories did not seem like good news for pharma in November and it still could turn out badly, but things have started out pretty well.

The Politics of Merck’s Gardasil

Another tough week for Merck.

First, the Annals of Internal Medicine takes the company to task for running a "seeding" study of Vioxx at the start of the decade, a charge Merck disputes--but of course that only means more negative headlines.

Then, the New York Times upbraids the company for pretty much everything it has ever done with the HPV vaccine Gardasil—up to and including developing a vaccine for cervical cancer prevention in the first place.

The very next day (quite a coincidence, no?) the New England Journal of Medicine publishes an an article affirming the cost effectiveness of the vaccine in its currently indicated population of adolescent girls, but questioning the cost-effectiveness of vaccinating young women (aged 21-26). Not what you want to read when you have a supplement pending for use in the 27-45 population.

And, last but not least, another chapter in the Vytorin saga, with FDA issuing a public declaration that it is looking into the apparent association between the cholesterol drug combo and an increased risk of cancer seen in the SEAS trial. (And, no, as far as we know Merck has no studies suggesting that Gardasil prevents Vytorin-associated cancers.)

In that context, we think Merck may have dodged a bullet on Saturday morning, when Barack Obama issued the text message heard round the world, announcing Delaware Senator Joe Biden as his Vice Presidential running mate.

What does this have to do with Merck? We think the good news for the company is who Obama didn’t select—Virginia Governor Tim Kaine (pictured above). Kaine was an early front-runner for the pick, but was eclipsed in the home stretch when the Obama campaign decided to place a greater emphasis on foreign policy experience.

And Kaine is also featured in the New York Times piece, as a champion of mandatory vaccination as a condition of school entry. And, according to the Times, Merck did all kinds of stuff to make that happen, like (gasp!) investing in Virginia, and also (say it ain't so!) hiring lobbyists who used to work for the governor.

All kidding aside though, we’re guessing that Merck is just as happy not to have Gardasil so directly interjected into the Presidential campaign. At least, not right after the Times piece.

But we're betting that Gardasil will be talked about on the campaign trail this fall--and probably not in a context that Merck (or the rest of the industry) will welcome.

The HPV vaccine is, quite simply, a politically volatile project. Merck knows that better than anyone. During development, the company reached out to right-leaning religious organizations to help head off the perception that Gardasil would be a “sex vaccine.” But the company’s aggressive push for coverage mandates backfired with some negative publicity about the lobbying campaign—and even drew fire from politically liberal organizations that viewed coverage mandates as paternalistic or even patronizing.

And, somewhere along the way, Merck managed to alienate many in the public health community who you would think would welcome the vaccine with open arms. Including, for example, Diane Harper--one of the principal investigators on the Gardasil trials. Here is what the Times reports:

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.

“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”

(Conflict of interest mavens take note: The Times carefully chronicals some relatively modest payments by Merck to various experts who have spoken up on Gardasil's behalf, but does not offer any estimate of payments from Merck to Harper.)

Harper is not alone in expressing discomfort with Merck's sales approach. Public health advocates are excited to have so much investment in vaccines. But they are terrified that Big Pharma marketing tactics could taint the whole sector, and undermine the notion of vaccination altogether. (We've written extensively about this attitude before. Start here.)

Ironically, Merck's investors are having the exact opposite reaction. They are concerned that Gardasil sales are slowing down--as if the brand should replicate the Januvia-style growth curve, rather than the historic vaccine model. Imagine how disappointed they would be if Merck had taken the go-slow approach some of the public health advocates wanted!

So Merck finds itself in a bind: marketing a well-recognized pharmaceutical brand that raises red flags with some historically conservative groups (who still see a "sex" vaccine) and other traditionally liberal voices (who see in Merck's marketing of Gardasil all the worst of industry practices they want to change). Commercially, it is full steam ahead (because, after all, what choice does Merck really have except to make the most of its brands?)

There is some good news. Obama's health care reform agenda includes initiatives to expand insurance coverage to recent college graduates, an objective one Obama advisor described at a recent health policy forum sponsored by the National Journal as critical "now that we have things that are critical for young people, like HPV vaccines."

The question is: will that talking point be retired now that Gardasil may be just another short-hand for the problems of Big Pharma?

Hillary Clinton's FDA

Slow summer so far. Not a lot going on. Washington is ready to go on its August hibernation. So I thought I would drop this quick note to jumpstart some watercooler talk before everyone goes to the beach.

Democrats are champing at the bit at their chances of regaining the White House in 2008. While there will be trench warfare over Medicare Part D drug prices and universal healthcare, one area that's sure to change (I'm not going out on a limb here) is personnel.

While the candidates themselves probably don't have a clear idea of who they would choose to lead key government agencies, they at least know who they like and who they trust on certain public policy issues.

Therefore, I found it interesting to see who Hillary Clinton had standing beside her during a campaign appearance "block party" in Washington, D.C. in June. It was Susan Wood, former women's health head at FDA, who resigned from the agency in protest over the delay in approving the switch of the morning-after pill from prescription to OTC. Wood stood next to Clinton, along with many other prominent women, including former Secretary of State Madeline Albright, during the outdoor event, which took place in the heart of downtown. Wood has not been shy about her support for Clinton. And neither has Clinton been shy in her support for Wood. During FDA Commissioner Andrew von Eschenbach's confirmation hearing before the Senate Health Committee, Clinton singled out Wood, in attendance, for her courage in resigning her post over the morning-after pill.

Wood is now a research professor at the George Washington University School of Public Health and Health Services. Under President Hillary Clinton, would Wood go back to FDA? Would she consider the job of commissioner if Clinton calls her to duty? I asked her.

"The first is easy, I truly enjoyed working in government health policy for 15 years, and so would be happy to come back to FDA in the future if an opportunity ever arose," Wood said via email. "I haven't ever considered the second one, and it is so hypothetical I don't know how to answer it, sorry." I bet I know what she would answer to the second question, and it's this.

I wonder how the drug industry would react to a Susan Wood FDA?

Next: Sam Brownback's FDA

Big Week For the Bushes

While President Bush hosts Russian President Vladimir Putin at the family’s tiny Kennebunkport bungalow , Jonathan Bush, a first cousin of the president, is having a fairly big week himself. Athenahealth Inc., the company he co-founded and leads, filed to go public. One of the few success stories to emerge from the e-health mania of the late 1990s, the Waltham, Mass.-based company—which manages billing and collections for physician offices—hopes to sell up to $86 million in stock. Athenahealth is a service, rather than a software company, although its service is Internet-enabled. Why bring this up in the IN VIVO blog? First, it gives us a chance to run dueling Bush photos. Second, Jonathan Bush matches his cousin in swagger and has suggested in the past that VCs don’t have the fortitude to invest in health care services/IT companies like his. We recently wondered aloud whether David Brailer's new $700m effort will alter that perception. Third, this will be an important IPO. A poor showing could be a setback for the health care IT/services industry.

Now back to your regularly scheduled pharma discussion.

p.s. In case you were wondering what global warming could mean to future Bushes. We suspect the Crawford Ranch is safe.

What Drug Makers Can Learn from Vaccines

Drug executives worried about rising safety hurdles, demands for larger trials and politicians’ growing influence on drug regulation could do worse than learn from their counterparts in vaccines.

Massive trial sizes and squeaky-clean safety have been part of the game in vaccines for years—since these are products given to millions of healthy individuals. “We’re used to these challenges,” Didier Hoch, President of Sanofi Pasteur MSD (SPMSD) told IN VIVO Blog this week.

And they’re used to dealing with a few of the other challenges drug firms are now facing, too, including demands for sound health economic and epidemiological data to support reimbursement and the need to engage not just with doctors, but a range of other stakeholders, too, including payors, policy-makers, patients and health workers.

As drug companies stumble, they too have to make the shift, as marketing gurus call it, from "share-of-voice" to "share-of-care". Many are still struggling to supply adequate cost-effectiveness data (and may as a result resort to risk-sharing reimbursement deals like Janssen-Cilag's UK proposal for Velcade).

Vaccines companies are used to dealing with politicians and policy-makers, since vaccines typically fit into national health care strategies. "We're already political," notes Hoch. "We already have the broader, global outlook" of how a product can improve public health and save costs, and the data to support that.

Hoch can point with confidence to cervical cancer vaccine Gardasil, which parent company Merck & Co. launched in the US last year and which is on track for blockbuster status, according to analysts. Indeed, Gardasil illustrates how vaccine products, as well as practices, are closing the gap with therapeutics--in terms of innovation, and price.

Gardasil is getting to market across Europe almost as fast as a classical drug (far faster than some traditional vaccines such as Wyeth's Prevnar against pneumococcal bacteria), according to Hoch, largely because preventing cancer is relatively novel. The crop of epidemiological and health economic data, plus the 30,000 + trial size, will have helped, too.

And at €330 per person (for three doses), Gardasil knocks down the old theory that vaccines don't command premium prices. (Though it’s still cheap enough, relative to some cancer drugs, for authorities to reimburse, as they have agreed to do in all of the largest European markets, other than the UK.)

Now sure, vaccines have been hot for some years now: bioterrorism and bird flu were just some of the factors that led to a scramble of Big Pharma (and little biotech) into the field; some returning to what they’d earlier cast aside.

They will get hotter still. Scientists are figuring out how to vaccinate against a wider range of conditions--including ones that haven’t even arrived and may never will, like bird flu. As we reported a few weeks ago, Novartis just committed up to $500m for an anti-smoking vaccine from Cytos. SPMSD and others have more novel vaccines, like Zostavax for shingles and post-herpetic neuralgia, in the pipeline.

Meanwhile, FDA and other regulators are becoming increasingly sceptical of drugs that treat the symptoms of disease, and looking for products which get closer to addressing the cause, or progression, of certain illnesses. Preventing them altogether is even better. And cheaper.

Small wonder, then, that Hoch has, over the last couple of years, had a direct reporting line into Sanofi-Aventis’ outgoing big boss, Jean-Francois Dehecq. Vaccines matter (and perhaps even more now, after one-time-potential blockbuster rimonabant’s big stumble).

SPMSD sets one final example that drug firms might take note of: R&D cooperation. Sanofi Pasteur MSD was created in 1994 as a joint venture between Sanofi-Aventis and Merck. Any vaccine in either company’s pipeline passes to SPMSD after Phase II for further development, approval and marketing in Europe.

The JV was set up because vaccines require large up front investments and significant regulatory expertise, including understanding of, and links to, each European government's policy-makers and approval system.

Given the rising costs and falling productivity of R&D in regular drug firms, pooling costs and risks doesn’t seem a bad idea.