The Side Effects of Side Effects

• 03.19.2007

Here's an interesting article from Medical Marketing & Media, with many good interviews (Dan Troy, Scott Gottlieb, Steve Galson, Andy von Eschenbach, Dan Carpenter, Sheila Burke, etc.), on the timely question, Wither PDUFA?

Voila la link ...

http://www.mmm-online.com/content/index.php?id=77&no_cache=1&tx_magissue_pi1[sword]=warren%20ross&tx_magissue_pi1[pointer]=0&tx_magissue_pi1[showUid]=422

Worth a look.

Jamie – You sunk my battleship!

• 03.16.2007

At today’s Capitol Hill Sherrod Brown/Jamie Love-in on the joys of compulsory licensing (aka “patent theft”) of pharmaceuticals, the LoveMan showed his true colors.

Jamie said he'd encourage all nations to issue compulsory licenses on all drugs. And when asked why governments like Thailand shouldn’t first try to negotiate with drug companies, he replied that countries couldn't let the drug companies know what they intended to do because they’d “call Karl Rove and, before you know it, battleships are on the way over.”

Jamie Love's true colors? Gun-metal gray and purple haze.

And Dont Forget the Salsa....

• 03.16.2007

Thanks to Stephanie Saul of the NYT for bringing this epidemic of sleep-eating, nacho-munching while driving , to a screeching halt....

http://www.nytimes.com/2007/03/15/business/15drug.ready.html?em&ex=1174190400&en=299f339292b51d83&ei=5087%0A

"The review (of sleep medications) was prompted, in part, by queries to the agency from The New York Times last year, after some users of the most widely prescribed drug, Ambien, started complaining online and to their doctors about unusual reactions ranging from fairly benign sleepwalking episodes to hallucinations, violent outbursts, nocturnal binge eating and — most troubling of all — driving while asleep.

Night eaters said they woke up to find Tostitos and Snickers wrappers in their beds, missing food, kitchen counters overflowing with flour from baking sprees, and even lighted stoves.

Sleep-drivers reported frightening episodes in which they recalled going to bed, but woke up to find they had been arrested roadside in their underwear or nightclothes. The agency said that it was not aware of any deaths caused by sleep-driving.

The reports gained credence from scientific studies. A forensic toxicologist in Wisconsin, Laura J. Liddicoat, gave a presentation at a national meeting on six instances of Ambien-impaired driving.

And Dr. Carlos H. Schenck and Dr. Mark W. Mahowald of the University of Minnesota said that they had been studying cases of nearly 30 Ambien users who developed unusual nighttime eating disorders."

Any info as to whether these people had ingested other meds or alcohol or other substances other than Snickers bars or had an other conditions...? Way to dig Stephanie.

Drugwonks Pop Quiz

• 03.16.2007

Which readily available sedative is associated with the most traffic accidents according to the National Transportation Safety Board:

A. Ambien
B. Benadryl
C. Lunesta
D. Sanjaya Malakar

Anyone who answered D has been watching way too much American Idol. The correct answer is B.

Prescription and OTC medicines that can cause drowsiness include analgesics (pain relievers), antianxiety medication, allergy medicines (antihistamines), blood-sugar medicines, antidepressants, tranquilizers, blood pressure medicines, motion sickness medicines, ulcer medicines, antibiotics, antiseizure medicines, cough syrups and decongestants. According to the National Transportation Safety Board (NTSB), the three most commonly used OTC medications that cause drowsiness are pain relievers, antihistamines and antidepressants.

According to a report published by Vanderbilt University, taking sedating antidepressants even 10 hours before driving is equivalent to driving drunk.

The Good, the Bad, and the Brown.

• 03.16.2007

Some brickbats and bouquets from the March 14 HELP hearing, “Drug User Fees: Enhancing Patient Access and Drug Safety” ...

Bouquets to Senator (Chairman) Kennedy who said the user fee system “demonstrates the failure by Congress to give FDA the funds it needs to do the job that the American public counts on it to do.” And that Congress should “correct this failing, so that FDA does not have to rely excessively on user fees for its basic budget.”

Brickbats to Senator Mikulski who believes there is a “perception that FDA is politicized” because of events like Dr. Susan Wood’s resignation as the Office’s Director, and recent reports that Dr. von Eschenbach intends to cut the Office’s budget by 25%.

And bouquets to Commissioner von E for “clarifying” that reports about a proposed 25% cut in the Office’s budget are “misperceptions.” He stated that he has “no intention to reduce FDA’s commitment to women’s health.”

Bouquets (along with the Dan Troy Prize for First Amendment Sensitivity) to Senator Richard Burr who pointed out that S. 484’s two-year ban on DTC for certain products “will probably not meet a constitutionality test.”

And brickbats to Senator Sherrod Brown who shrugged off the relevance of the US Constitution by commenting that he’s not sure if there are constitutional issues related to limiting DTC advertising.

(Note to Drugwonks readers – we are sure.)

We award our final bouquet to Mark McClellan who pointed out to the committee that that FDA “needs the manpower, technical skills, and technical support to carry out their increasingly complex oversight requirements effectively.” And that “we should aim for nothing less than world class data for evaluating drugs through their lifecycle.”

Amen.

FYI -- Complete witness testimony is available at:

http://help.senate.gov/Hearings/2007_03_14/2007_03_14.html

Enjoy.

The Profit Stigma in Medicine

• 03.15.2007

Meredith Salisbury, is the editor of Genome Technology, the one 'trade' publication everyone must read to learn about the tools and toolmakers that will shape medicine in the 21st century. In the current issue of her publication she has put together the Myths and Misconceptions the people hold about patenting ideas in academia. Most of them comprise the intellectual framework of those that want to drive companies and private investment out of medicine altogether. They are Luddites. As Ms. Salisbury points out concisely and elegantly:

"...More academics follow through on patenting because it can be the fastest and most effective way of getting a research breakthrough to the public. Companies that have to commercialize new technology or other types of discovers want some assurance that they're protected while they're making it ready for market and the first thing they look for is a solid IT position."

For the entire article and to sign up to become a subscriber (you should) go to genome-technology.com

Do Slower Zyprexa Sales = More Untreated Disease?

• 03.15.2007

From Marketwatch.com
http://www.marketwatch.com/news/story/lilly-ceo-zyprexa-2007-seen/story.aspx?guid=%7BF408D59C-9B62-4814-872E-6D94F8186E15%7D

Eli Lilly & Co. Chief Executive Officer Sidney Taurel said Wednesday that because of lingering safety concerns, sales of its blockbuster psychiatric drug Zyprexa in 2007 will largely be flat with 2006 sales.
In an interview with reporters, Taurel said that while Lilly
doesn't anticipate a notable decline in Zyprexa sales, it also doesn't see any substantial growth on the horizon, at least for this year.
"The positioning of the drug is for our sales reps to help physicians identify those patients for whom the efficacy of the drug offsets the potential concern for side effects, and those are, in particular, the urgent patients," said Taurel.
Taurel made his remarks during a meeting of the Boston College Chief Executive's Club in Boston.
Used to treat schizophrenia and bi-polar disorder, Zyprexa has been linked with substantial weight gain in some patients and suspected of triggering diabetes in others.
"They (patients) can use it for awhile, and if they find out there's too much weight gain, they can switch to something else," Taurel continued. "I think the product has found its positioning that way and that's why sales have stabilized."

Except people don't switch to something else. They just stop taking drugs. Period. Or, as with the case when the media fed the SSRI scaremongering, they don't take drugs at all. As with depression, untreated, schizophrenia and manic depression can lead to violence, self-mutilation, substance abuse and suicide.

I am afraid that the slowing sales is a signal of tragedy to come. Lilly has been warning of weight gain and diabetes for years. Coming up with something other than trial and error before starting with meds is what we need to shoot for and is best for all. But others have fanned the flames of fear.

Prescription for Bias

• 03.15.2007

Here's something that should be required reading for all those covering the biotech industry at the WSJ. Think of it as diversity training..

The Business & Media Institute’s new in-depth study Prescription for Bias,” which documents unbalanced media coverage of the pharmaceutical industry. Released today, the report quantifies the bias against drug companies based on analysis of 132 stories on prescription or over-the-counter drugs from the ABC, CBS and NBC evening newscasts between January 1 and Sept. 30, 2006.


Among the study’s key findings:


· Industry Ignored – 80% of stories excluded the viewpoint of the pharmaceutical industry

· Cost to Consumer – Media overemphasized consumer drug costs as opposed to drug development costs at a radio of 11:1

· Companies Unnoticed – Only 22% of the stories even named the company responsible for developing life saving cures

· What Development Costs? – A mere 2% of the stories addressed the cost to companies for researching and developing drugs


The report also includes recommendations to improve network coverage.


The full report can be found at:



http://www.businessandmedia.org/specialreports/2007/PrescriptionForBias/PrescriptionForBias_execsum.asp



Oddly enough, a story that aired on all networks last night was consistent with many of the reports findings. When reporting on the new breakthrough drug Tykerb, the media failed to give due credit to GlaxoSmithKline or report the development costs. You can read about it here:



http://www.businessandmedia.org/articles/2007/20070314165615.aspx

Lies About Generics and Access to Medicines

• 03.14.2007

I have been going back and forth in my own mind about my initial reaction to Abbott's decision to not sell new medicines in Thailand pending a shift in the policy of patent theft on the part of the junta-run government there. At first I thought, this will only make the perception worse. But then it struck me it is not as if compulsory licensing has actually made any medicines any more available in any country. The only people who benefit from compulsory licensing appear to be the small circle of generic companies, government bureaucrats and media-thirsty NGOs who use the tactic to use drug companies to divert attention away from the real problems causing disease. Just as free food does not solve the problem of world hunger and free measles shots has not eradicated measles (500,000 African kids a year still die from measles) the short sick history of CL has proven that low cost copycats of drugs do not improve health in third world countries. Just the opposite, it usually makes things worse, encouraging piracy, profiteering and counterfeiting. I have said it before and I will say it again, the NGOs who support CL are more interested in killing drug companies than in saving lives.

Good for Abbott and Novartis for refusing to sell new medicines. Other companies should follow suit... and set up their own distribution programs as necessary.

A Breakthrough: Pharma CEO Talks About Science

• 03.14.2007

Sid Taurel, Lilly CEO has an editorial in the Boston Herald about the mission of drug companies, of all things. More CEOs should talk about the science they are investing in and do it often.


Taurel writes:

"We are now beginning to understand biology as a set of information processes, and we’re developing realistic models of how disease and aging progress. And, we are developing the tools to reprogram them.
I believe that this represents the most exciting and important story in any technology field in this new century.
It might take decades for biologists to map all of this territory . . . and fully solve these new puzzles. But the good news is that patients will not have to wait decades to see the medical benefits of this massive effort. "

Unless military juntas, backed by certain members of Congress, make a hash of IP globally.



http://news.bostonherald.com/editorial/view.bg?articleid=187903&format=&page=1