News

Ireland probes Lipitor patient's death

Tracy Staton — Fri, 08 Aug 2008 10:55:38 -0400

An Irish man's death has prompted calls for doctors to suspend Lipitor use when treating patients with certain antibiotics. A 58-year-old man died from a rare muscle-deterioration malady that officials say was likely caused by the interaction of Pfizer's cholesterol med and the antibiotic fucidic acid. According to the Independent, medical journals have reported three other deaths from a bad interaction between Lipitor and antibiotics.

The Cork County Cororner, who presided over an inquest into the man's death, advised physicians to consider taking patients off Lipitor when they're being treated for an acute illness--and the jury recommended changing the drug's label to highlight the interaction risk with fucidic acid.

Of course, a county coroner and jury has no jurisdiction to change a drug's label or issue prescribing advice. But the case is all over the Irish papers today--and the publicity may prompt the proper officials to get involved. Indeed, the Irish Medicines Board is said to be looking into the man's death now. Pfizer, however, says that the drug's label already cautions doctors about the potential for the muscle problem, known as rhabdomyalisis. The risk of developing it is about 1 in 10,000 for Lipitor patients, the company said.

- read the story in the Irish Times
- check out the Independent's coverage

Calls for price cuts on cancer meds

Tracy Staton — Fri, 08 Aug 2008 10:32:01 -0400

If the government says cancer drugs aren't worth the cost, then what? Ask drugmakers to cut their prices. After the U.K.'s National Institute for Health and Clinical Excellence rejected four kidney-cancer treatments yesterday, advocates immediately ramped up pressure on pharmaceutical companies to lower their price tags. Report

Add 'uninsured' to pharma's problems

Tracy Staton — Fri, 08 Aug 2008 10:27:56 -0400

We all know the challenges pharma faces: generic competition, patent expirations, sluggish pipelines, pricing pressures. Or do we? A new study suggests that the huge volume of uninsured and underinsured people may be seriously cutting into drugmakers' sales. Millions of Americans have chronic diseases such as diabetes and high blood pressure--the kind of disorders that keep patients on meds for years--but aren't being treated because they don't have insurance.

The study estimates that one in three of uninsured adults has a chronic illness that's going untreated--that's about 11 million people (and some say that's an underestimate, that it might be more like 16 million). The study's lead author notes that treatments for these illnesses are standard and widely available if you do have insurance. And we know what those treatments are: meds, meds and more meds.

- read the story in the New York Times

Pharma fights Mass. disclosure bill

Tracy Staton — Fri, 08 Aug 2008 10:09:48 -0400

Drugmakers are kicking back at a Massachusetts marketing-and-disclosure bill that we reported on a few days ago. The outright ban on gifts to docs didn't make it into the compromise measure, but pharma isn't happy nonetheless. The bill would require disclosure of any payment or gift of $50 or more--and companies are saying that handing over that info would have a "chilling effect" on life sciences in the state.

How so? Well, PhRMA is pointing to language in the bill requiring disclosure of the "nature and purpose" of every doc payment. The industry association says that could be construed to mean that clinical trial data would have to be an open book if docs were paid to be part of those trials. We think that's stretching a bit--maybe to scare the governor into vetoing the bill?--but then again, we aren't lawyers.

- read the post at Pharmalot

More meds doubling in price

Tracy Staton — Fri, 08 Aug 2008 09:50:33 -0400

Prices have ballooned by 100 percent or more for a growing number of drugs, according to a new study. In fact, the number of branded meds whose prices have grown that much could double this year from four years ago. In 2007, the average wholesale price of 26 brand-name meds jumped 100 percent or more in a single price increase, up from 15 in 2004. In the first half of 2008, 17 made that list.

Many of the price increases have come on drugs that treat rare but serious conditions. For example, Questcor Pharmaceuticals boosted the price of Acthar, which treats spasms in babies, to $23,000 from $1,650 a vial.

- read the story in USA Today

Can Merck boost Singulair sales?

Tracy Staton — Thu, 07 Aug 2008 11:13:09 -0400

One of the shining stars over at Merck has been Singulair, the allergy and asthma med that pulled in some $4.4 billion last year. Well, for the most recent quarter, sales actually slipped by 1 percent as patients have defected to the new over-the-counter Zyrtec sold by Johnson & Johnson. Plus, the FDA's March announcement of a probe into a potential link between Singulair and suicidal behavior--and a fairly mild spring allergy season--didn't help. Merck acknowledged the flattening sales, lowering its forecast to a range of $4.4 billion to $4.6 billion from its previous estimate of $4.6 billion to $4.8 billion.

What can Merck do to turn it around? The company is offering $20 coupons for Singulair on its website, and it extended its spring ad campaign into the summer. "[W]e are taking additional steps to further support the brand," the company said late last month. Third-quarter sales figures will show just how successful those efforts turn out to be.

- read the story in CNN Money

Comparative effectiveness bill hits Senate

Tracy Staton — Thu, 07 Aug 2008 11:05:11 -0400

How do different antidepressants stack up? Blood-pressure meds? Diabetes drugs? Do we know? Well, Sen. Max Baucus says he aims to find out: He's introduced a bill that would create an institute for comparative-effectiveness research. The not-for-profit would operate separately from the government, but would include reps from Health and Human Services, National Institutes of Health, and the Agency for Healthcare Research and Quality--plus drug and device makers, patients, and doctors.

The institute would be funded by public and private payers--a.k.a. Medicare and insurance companies. “Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible," Baucus said in a statment, "but right now that data is scarce and unorganized."

Not everyone is sold on the comparative effectiveness idea. Some fear that it would end up going the way of the U.K.'s National Institute for Health and Clinical Excellence--which, though well respected, does get into hot water from time to time for rejecting treatments based on cost. We'll see who prevails.

- read the press release
- see the post at Pharmalot

How to merge Roche and Genentech

Tracy Staton — Thu, 07 Aug 2008 10:52:03 -0400

Want a primer on the legal ins and outs of Roche's bid for Genentech? We don't blame you. Between state and federal laws and the two companies' own affiliation agreement, the deal could get pretty complicated. Luckily, DealBook has obliged. Report

Analysts: Tysabri scrips will suffer

Tracy Staton — Thu, 07 Aug 2008 10:46:02 -0400

When Biogen Idec announced last week that a potentially fatal brain infection had cropped up again in Tysabri patients, markets reacted swiftly--and negatively. But investors were only guessing at how that new information might affect new scrips for the drug, which has been hailed as a miracle treatment by many multiple sclerosis patients. Now, financial analysts have done some number-crunching to quantify those long-term effects. And the news isn't good.

Deutsche Bank analyst Mark Schoenbaum told investors that his best-case scenario pegged Tysabri at 75,000 users by 2013--not nearly the 100,000 patients Biogen had been shooting for by 2010. Under more conservative estimates, Schoenbaum predicted 56,000 Tysabri patients, again by 2013. And worst case? If more safety problems emerge, the drug could get pulled from the market--again. (For what it's worth, though, other analysts have said they don't expect Tysabri to be withdrawn.)

Meanwhile, a JP Morgan analyst estimated that the number of Tysabri patients by 2010 would be only 50,000--even before the two cases of progressive multifocal leukoencephalopathy (PML) were reported. The analyst said he doesn't expect that estimate to drop much further.

- read the story in the Boston Globe

U.K. to double flu-drug stockpile

Tracy Staton — Thu, 07 Aug 2008 10:31:44 -0400

Good news for Roche and GlaxoSmithKline: The U.K. is planning to double its stockpile of anti-flu meds to prepare for a possible pandemic. The government has secured enough drugs to dose about one-fourth of its population; now it wants to up that fraction, and so it's soliciting proposals from drugmakers who want to fill the gap. Roche, of course, makes Tamiflu, and GSK sells Relenza--the two antivirals governments tend to store against pandemic flu.

As you know, Roche recently introduced a program by which it would set aside Tamiflu for governments and companies that want to secure a supply; the drugmaker would keep the supply within date and ship it out on demand.

Antibiotics makers could benefit from the U.K.'s new stockpiling effort, too. The government plans to store those drugs to help treat complications of the flu, such as pneumonia. A recent study showed that during the last major flu pandemic, in 1918, bacterial illnesses that cropped up in flu patients killed more people than the flu virus did on its own.

- read the story in the Telegraph

NICE rejects four cancer meds

Tracy Staton — Thu, 07 Aug 2008 10:16:02 -0400

The debate over costly oncology meds rages on in the U.K. as the National Institute for Health and Clinical Excellence rejected four high-tech drugs for advanced kidney cancer treatment: Sutent (Pfizer), Avastin (Roche), Nexavar (Bayer) and Torisel (Wyeth). NICE acknowledged that the drugs do extend life--by up to six months--but concluded that the money would be better spent on other patients.

The decision drew immediate fire, not only from patient advocates, but from cancer researchers and doctors, too. One doctor said there was no point in accepting referrals for advanced kidney cancer patients without those drugs, because most don't respond to the only other alternative, interferon.

The outcry might actually have some effect: NICE initially rejected Herceptin outright for breast cancer treatment, then relented after receiving an outpouring of complaint. The agency's final kidney cancer treatment guidance will come through in January.

- read the story in the Times
- check out the Telegraph's coverage

Roche could top Pfizer, Lilly by 2014

Christe Bruderlin-Nelson — Wed, 06 Aug 2008 10:35:03 -0400

While Pfizer, Eli Lilly, J&J, GlaxoSmithKline and Sanofi-Aventis face expiring patents and a sizeable drop in rank in the coming years, Roche might hold strong and is poised to carry about 6 percent of the global prescription drug market in 2014. Ranked fifth in 2007, the company is also less at risk of losing revenue to genetic competitors. Report

FDA enters (fake) advertising business

Christe Bruderlin-Nelson — Wed, 06 Aug 2008 10:32:54 -0400

The FDA might be creating some faux direct-to-consumer commercials for a pretend blood pressure medication, which it plans to follow with an internet survey of 2,400 adults to gauge the response of consumers aged 40 and older to the ads.

The agency wants to test whether the safety warnings it requires in ads take a backseat to the images in the ads, and says it issues warnings to multiple companies every year about misleading ads and ads that overstate a products safety or efficacy.

If approved, the fake ads will have various images and text onscreen while a narrator reads warnings. Then the follow-up surveys will attempt to gauge viewer attitudes and perceptions regarding the adds. The FDA submitted the study to its Office of Management and Budget for approval. Stay tuned.

- read the Pharmalot blog post
- get the story at the Star-Ledger

J&J pays up for Pfizer consumer unit error

Christe Bruderlin-Nelson — Wed, 06 Aug 2008 10:22:19 -0400

In 2006, Johnson and Johnson acquired a plant in Lititz, PA when it bought Pfizer's consumer health care division. Now federal lawmakers contend that the plant violated paperwork regulations for controlled substances in Pennsylvania during the preceding five years, from 2001 to 2005.

Pseudophedrine is the controlled substance under question, and authorities allege that Prizer's consumer unit imported Benadryl-D, which contains pseudophedrine, from Canada without officially notifying the US Drug Enforcement Agency under the Controlled Substances Act. The Act requires companies to provide written notification of importation of any controlled substances.

J&J settled the case; it will pay $511,000 to the federal government because of the error.

- check out the story at CNN Money
- read the Pharmalot blog post
- get more from the Wall Street Journal
- check out the US Department of Justice statement

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Four companies drop $6 million on lobbying

Christe Bruderlin-Nelson — Wed, 06 Aug 2008 10:16:49 -0400

Four Big Pharma companies spent some serious cash to lobby congress in the second quarter of 2008. A common concern was legislation that would allow FDA to approve less-expensive generic versions of biotech drugs, as was a bill to update the U.S. patent system (the latter remains stalled in the Senate). Likewise, implementation of Medicare drug benefits for seniors was a hot topic.

Bristol-Myers Squibb spent $830,000 lobbying government over various drug and patent issues. In addition to the generic biotech issue and U.S. patent system issues, the New York giant put dollars toward lobbying on a chemical used in children's food packaging called bisphenol-A, which is used to seal food containers. They also lobbied the Commerce Department and the Patent and Trademark Office.
Also in the second quarter, Amgen spent nearly $2.9 million lobbying the federal government. Obviously, Amgen was also putting money toward preventing FDA from approving generic versions of biotech drugs and lobbying on efforts to reform the U.S. patent system. Implementation of the Medicare drug benefit for seniors was also a priority for Amgen.
Abbott Labs, which makes drugs and medical devices, spent more than $1 million. Like BMS and Amgen, Abbott lobbied on the bill to update the U.S. patent system and the generic biotech drug legislation. Abbott also lobbied on funding for the FDA and for AIDS-awareness programs.
Finally yet importantly, the British came. AstraZeneca spent more than $1.3 million lobbying during the second quarter. AstraZeneca had interests in the Medicare prescription drug benefit for senior, but also lobbied Congress on intellectual property and trade issues, on importation of cheaper prescription drugs from foreign countries and on increased funding for FDA. AstraZeneca also lobbied the U.S. Trade Representative's office, as well as the departments of Treasury and Health and Human Services during the period.

- get more on BMS from Forbes
- here's the take on Amgen
- read more about AstraZeneca at Forbes
- get the article on Abbott