"Science" pays a dividend for O'Bomber - Farmed and aborted foetuses to yield up their rich stores for pharma to plunder.

A little bit of recent history.

Obama Executive Orders Will Force Abortion, Embryonic Stem Cell Funding - by Steven Ertelt LifeNews.com Editor November 9, 2008

Washington, DC (LifeNews.com) -- "Members of the team Barack Obama has put together confirmed over the weekend that the incoming president will immediately overturn executive orders President Bush put in place as soon as possible after he takes office. The Bush orders have protected taxpayers on key pro-life issues."

The White House website on the section devoted to women - Supporting Stem Cell Research - explained immediately after O'Bombers election ""Obama is a co-sponsor of the Stem Cell Research Enhancement Act of 2007, (twice vetoed by President Bush,) which will allow research of human embryonic stem cells derived from embryos donated (with consent) from in vitro fertilization clinics. These embryos must be deemed in excess and created based solely for the purpose of fertility treatment,"

TheStockAdvisors.com asked financial experts to name their top stock pick if Obama won the election. Oct 7th 2008

"If Barack Obama wins the presidency, one under-the-radar play would be embryonic stem cell research; Geron (NASDAQ: GERN) is the current leader in embryonic stem cell research among publicly traded companies."

It is commonly believed that embryonic stem cell research in the U.S. is restricted - it is not. The real issue at is federal funding, and whether federal taxpayer dollars should be used to help fund the research - which President Bush had stopped. (In fact US institutions lead the world in this research)

As at the time of the Presidential election , federal funding was only available to firms that won't create embryos for use in scientific research or clone them for any reason, and that are working with stem cell lines derived from embryos destroyed before August 9th, 2001.

Menlo Park. CA. Geron (US based pioneers in the field since 1999) was the only publicly traded company of the more than a dozen institutions listed with stem cell lines that qualified for federal funding , who have been a pioneer in the field since 1999.

Geron has a large number of related stem cell patents. Some of its major areas of focus include spinal cord injuries, heart disease, and diabetes.

"If Obama takes office, there is a pretty good chance (said the Stock Advisers) that he and the Democrat controlled Congress will offer government funding for embryonic stem cell research. If this happens, expect Geron to head higher."

Today Geron issued a statement saying the US Food and Drug Administration had given permission to a Phase I trial. 10 paraplegic Patients will be injected in their spinal cords with GRNOPC1, a Geron- patented product containing embryonic stem cell-derived progenitor cells that have already been shown to repair nerves in animals with spinal damage. The "progenitor" cells were grown in the laboratory from stem cells taken from human embryos.(Bus Journal)

Geron shares rose 53.5% on the news.

Executive Order signed by O'Bomber in secret.

The ever impartial BBC report that President O'Bomber signed an Executive Order on Friday afternoon 23rd January , rescinding President Bush's ban without asking for coverage by the media .

It is apparently a complete coincidence that O'Bomber signed the EO, and the FDA gave the green light to Geron's experiments with government funded embryonic stem cells and the stratospheric rise in Geron share price - over a single weekend.

This is of course what big pharma (whose funds no doubt helped O'Bomber into office) wants, as they see embryonic stem cells, from live, farmed or aborted foetuses as the next magic (and hugely profitable) bullet intheir ailing (and increasingly unprofitable) drugs pipeline.

This is of course the sub text, the hidden coda in his inaugural speech last week when he said ..."We will restore science to its rightful place and wield technology's wonders to raise health care's quality... (APPLAUSE) ... and lower its costs."

PS : The common and oft repeated claim that the UK is a "world leader" in stem-cell research is challenged in a confidential report (Benchmarking: Academic, Clinical and Commercialisation Activities in Nesci, August 2008.) that lists only one UK research centre - London - in the global top 20.(TLS Friday 23rd Jan 2009)

UPDATE Geron shares ended Monday up US$ 1.05 = 15% @ US$ 8.15.

Merck herpes zosta vaccines have a production hiccup - HMP Gardasil vaccine is delayed for use in older women.

When we posted on Wednesday, May 31, 2006 about Merck Zostavax shingles vaccine could be a US$1 Bn. seller we were more concerned about finding a happy home for investment funds.

Big Pharma rides on blockbuster drugs that a (relatively) few people need to take forever, statins, anti - diabetic drugs,retrovirals or medication that is used on enormous populations eg vaccines. Zostavax seemed a likely candidate and so it has proved .

When we wrote about "an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain" we didn't then , but do now know what it means.

If you are over 60 or you have family who are give this serious consideration and see your doctor. Shingles is fucking painful... and it lasts. BTW shingles is not a one off, it can re-occur.

The bad news is that Merck are having production problems. They make a product called bulk varicella which goes into both Zostavax (annual sales approx US$230 Mn.) and a chicken pox vaccine for children Varivax both of which afford protection from the herpes zosta virus.

Difficulties with less potent batches have resulted in production delays as manufacturing changes require approval before vaccine production recommences so they have given priority to Varivax after a national program since 2006 suggested a second dose for children which doubled sales to a robust US$855 Mn. out of total vaccine sales last year of approximately US$3 Bn.

Merck have also hit problems with their preparation for protection for Human Papilloma Virus, the cause of most cervical cancers. Whilst the Merck vaccine Gardasil has approval from the FDA for the age range from 9-26 they have not yet approved extending use to the 27-45 age range. Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papilloma Virus that causes cervical cancer (currently acts against types 6, 11, 16, 18) . The company for now is dropping plans to pursue that expansion. There is also a potential to expand usage into males who can transmit the virus to their partners.

In the US Gardasil typically costs US$120 per dose, which means it costs US$400 to US$500 for the three-shot series plus physicians' charges. (Net Doctor details for use in UK)

Global sales of Gardasil rose 7 percent in the first quarter to $390 million. Cowen and Co has predicted annual sales of the vaccine would reach $1.9 billion in 2008 and jump to $3 billion by 2012.

Merck shares have fallen 37 % this year, principally due to setbacks to its cholesterol franchise and delays on introducing a new drug.


***** Zostavox vaccine is not currently available in the UK. A frozen formulation of the vaccine was granted a marketing authorisation (MA) in the EU in May 2006 for the prevention of shingles in individuals aged 60 years or older; a variation to the MA has been filed with the European Medicines Agency for a refrigerated formulation, but a final decision on approval has not yet been made. Zostavax is the first and only vaccine registered in Europe for this indication.

PS : Monday : An enquiry at a pharmacy today produced this response "Yes we do provide Zostavax although the product is currently on a manufactures backorder, with no release date, and we are now out of stock."

Merck win appeal in Texas Vioxx case

71 yearold Leonel Garza had a prior heart attack and heart bypass surgery, smoked for nearly 30 years and died of the second heart attack after taking Vioxx for less than a month.

In April 2006 a jury in Rio Grande City, Texas, awarded $32 million to his widow from Merck the manufaturers of Vioxx. The award — $7 million for compensatory damages and $25 million for punitive damages — was subsequently reduced to about $7.75 million under Texas law limiting damages.

Yesterday a three-judge panel of the Texas 4th Court of Appeals overturned the verdict, ruling in favor of Merck. The opinion was signed by Justice Sandee Bryan Marion. "Even viewing all the evidence in the light most favorable to plaintiffs, we conclude the evidence is legally insufficient to support a finding that plaintiffs negated, with reasonable certainty, Mr. Garza's preexisting heart condition as a plausible cause of his death,"

The judges stated that Garza's family did not prove his brief use of Vioxx caused two blood clots that the family's attorneys argued triggered his heart attack. The judges also concluded the family did not provide sufficient evidence to rule out his long-standing heart disease as the cause of his fatal heart attack.

"The appellate court recognized that there was insufficient evidence supporting the jury's verdict and, accordingly, rendered a final judgment in the case in favor of Merck," said Ted Mayer of Hughes, Hubbard & Reed, outside counsel for Merck. "Today's decision reaffirms that there is simply no reliable scientific evidence that Vioxx caused Leonel Garza Sr.'s heart attack."

The Garza case was excluded from the settlement program agreed by Merck who have paid US $4.85 billion into a resolution fund to resolve state and federal myocardial infarction and ischemic stroke claims filed or tolled by Nov. 9, 2007.

After the trial, a juror admitted previously borrowing more than $12,000 from Garza's widow, Felicia, an issue that Merck also raised in its appeal, this was not mentioned in the three-page appellate court decision.

Pfizer junks Jarvik - must find new way to get folks to eat statins for breakfast

Pfizer has decided to drop Dr Robert Jarvik from ads for Lipitor, Pfizers cholesterol-lowering drug, and the world's best-selling medication ( US$13.6 billion in 2006), after the US Congress (prompted by Michigan Democratic Reps. John Dingell and Bart Stupak) , said it was investigating whether Lipitor ads featuring Jarvik were misleading.

Pfizer President of Worldwide Pharmaceutical Operations Ian Read claims the ads provide valuable and medically accurate information about Lipitor, "the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions (add this to your dictionary along with "unclarity") and distractions."

Although Jarvik appears to be giving medical advice, he is not a practicing physician with a valid license in any state. Dr Robert Jarvik is the inventor of the Jarvik artificial heart and holds a degree in engineering from New York University and a medical degree from the University of Utah.

The company, says it is "committing to ensuring greater clarity in the roles and responsibilities of its spokespeople in its consumer advertising and promotion," is planning a new Lipitor ad campaign in the coming weeks... which of course it was going to do ...er...anyway. Pfizer would naturally be looking at better ways to spend the US$258 million they have spent on Lipitor advertising since January 2006, most on the Jarvik campaign, to protect Lipitor, from competition from cheap generics.

If they want to "ensure greater clarity " they could start by stopping using words like misimpressions .

Maybe this could mark the end of celebrity endorsements of medication such as Pfizer paying senator and one time candidate Bob Dole to pitch Viagra in 1999 . Merck & Co. Inc. paid Olympic skating champion Dorothy Hamill to appear in ads for Vioxx which she probably deeply regrets now..

See Video of Ad there is an interesting new development to explain the action of statins here

UPDATE Tuesday 5.20 GMT : Lord Patel apologises for providing a"misimpression" ...it now transpires that Dr Jarvik does not row, and possibly doesn't even know how to row and that the ads feature a "body double".... as does our fuzzy screen grab from the Pfizer promo video.Which pisses off scullers who have been suckered by Dr Jarik's apparently flawless technique. Dr Jarvik is 65.

The ads also feature Dr Jarvik wearing a very clean White Lab coat, which he did learn how to use after several hours training ... just prior to collecting his US$1.35 million fee.

IAG research the recall of on ads on TV - these are the confidential results for Most Recalled New Prescription Drug Ads Sept 1, 2006 - Sept 23, 2007 Click to enlarge

Isn't it curious what pharma thinks sways consumer choice ... but you can be absolutely certain that it has been very , very caerfully researched.

Why shouldn't we allow pharma to advertise direct to the consumer ... alcohol suppliers are allowed to, and they cause more direct and indirect damage to people's and society's health than the pharma companies do. Lunesta ? .. "Lunesta helps you fall asleep quickly..." Zyrtec ? an anti-histmaine non-drowsy allergenic treatment was only available on prescription but two months ago was allowed for sale OTC . Rozerem is another insomnia treatment Crestor is a statin

US Heparin production boosted by APP as Baxter and FDA still need to identify their problem with Chinese sourced drug component

It's an ill wind.

Schaumberg, IIlinois based APP Pharmaceuticals (formerly known as Abraxis Bioscience Inc. ) and Baxter each supplied roughly 50/50 o fthe heparin for the US market which is essential for haemodialysis. Now that Baxter have of heparin , APP have ramped up production to meet demand and have arranged new production lines at its Grand Island, N.Y., plant.

APP source the heparin product from several sources inspected and approved by both the FDA and the Chinese regulatory body SFDA.

APP shares rose 79 cents to $11.30 in trading on the Nasdaq on the news which was also affected by the University of Chicago Medical Center, announcing that it switched last month to APP product. A chain of 1,600 U.S. kidney-dialysis centers run by Fresenius Medical Care North America, a unit of Germany's Fresenius Medical Care AG, already have announced switching to buying exclusively from APP. Fresenius has 120,000 dialysis patients who get esential life saving treatments three times a week.

Shares of APP are still nearly 20 percent off a 52-week high of $15.25 the stock price hit in April of last year.

Baxter note that heparin makes up less than 1% of Baxter's corporate sales and are working with the FDA who are examining the Cherry Hill, N.J., Baxter facility and the Waunakee, Wis., plant of Baxter's supplier, Scientific Protein Laboratories LLC. Scientific Protein's Chinese joint venture, Changzhou SPL in Changzhou, China, is to be examined closely by a team that will include manufacturing experts and a Chinese-speaking chemist.

The FDA is still puzzling over the cause of the heparin reactions potentially tied to Baxter's version of heparin and they are also facing Congessional scrutiny about their failure to examine and approve Changzhou SPL which they claim was due to a mix up over similiar names of companies on their database.

Joseph Famulare, deputy director of the FDA drug center's office of compliance, said the name of the operation "that was sent to the office of compliance for evaluation was not the correct firm. It was another firm with a similar name," which had been inspected and found to be in compliance.

This problem has highlighted concern in the U.S. over the mounting number of foreign-sourced drug ingredients (unkown to many consumers) and the FDA's questionable ability to effectively monitor quality control.

Such Congressional concern might spill over into other practices outsourced to China - testing on animals, humans etc.,

US Pharma reps - how they are trained, how they target customers, how they affect prescribing

In 2004, spending for prescription drugs in the US was US $188.5 Bn. in 2005 ( 5 times what was spent in 1990) accounting for 10.7% of health-care expenditures. In 2000, pharmaceutical companies spent more than US$15.7 Bn. on promoting prescription drugs

US$ 4.8 Bn. of that went on detailing, the one-on-one promotion of drugs to doctors by pharmaceutical sales representatives / drug reps. The average sales force expenditure for pharmaceutical companies is $875 million annually.

Between 1995 and 2005, the number of drug reps in the US increased from 38,000 to 100,000 - about one for every six physicians. The actual ratio is close to one drug rep per 2.5 targeted doctors

A drug rep can expect to earn on average US$81,700, - base of approx US$60K plus $19,300 in bonuses.

To recruit, hire, train a rep costs about US90K - a pharma company can expect to spend US$150K per rep annually and double that for a speciality rep.

Against this outline of costs Following the Script: How Drug Reps Make Friends and Influence Doctors by Adriane Fugh-Berman and Shahram Ahari is an attempt to explain how drug reps actually work in the US.

The US has a unique, detailed and acurate method of tracking drug sales, by product, and prescriber.

1. Health information organizations, such as IMS Health ( is the biggest and cover 70% of prescriptions made), Dendrite, Verispan, and Wolters Kluwer, purchase prescription records from pharmacies.

Patient names are not included, the precribing physician is identified only by state license number, Drug Enforcement Administration number, or a pharmacy-specific identifier such identities can be linked to physician names through licensing agreements with the American Medical Association (AMA), which maintains the Physician Masterfile, a database containing demographic information on all US. physicians (living or dead, member or non-member, licensed or non-licensed). In 2005, database product sales, including an unknown amount from licensing Masterfile information, provided more than US$44 million to the AMA.

In the UK such sales would not be permitted under the Data Protection Act.

2. Pharamaceutical companies buy this information - Physicians are ranked on a scale from one to ten based on how many prescriptions they write.

Reps use prescribing data to see how many of a physician's patients receive specific drugs, how many prescriptions the physician writes for targeted and competing drugs, and how a physician's prescribing habits change over time.

“A physician's prescribing value is a function of the opportunity to prescribe, plus his or her attitude toward prescribing, along with outside influences. By building these multiple dimensions into physicians' profiles, it is possible to understand the ‘why’ behind the ‘what’ and ‘how’ of their behavior.” Data can be enhanced from other sources for demographics, but also behavioral and psychographic selections that help you to better target your perfect prospects”

Armed with this information the rep's role has changed over the last decade. He / she ruthlessly targets the physician and categorises them ;

“Hidden gems”: “Initially considered ‘low value’ because they are low prescribers, these physicians can change their prescribing habits after targeted, effective marketing.”

“Growers” are Physicians who are early adopters of a brand. Pharmaceutical companies employ retention strategies to continue to reinforce their growth behavior. etc.,

From this develops the procedures to manipulate Physicians - "Friendly " "Aloof" , "Mercenary" explained in this detailed chart here

Sharham Amari who was a drug rep for a major US Pharma company concludes ..

" The concept that reps provide necessary services to physicians and patients is a fiction. Pharmaceutical companies spend billions of dollars annually to ensure that physicians most susceptible to marketing prescribe the most expensive, most promoted drugs to the most people possible. The foundation of this influence is a sales force of 100,000 drug reps that provides rationed doses of samples, gifts, services, and flattery to a subset of physicians. If detailing were an educational service, it would be provided to all physicians, not just those who affect market share.

Physicians are susceptible to corporate influence because they are overworked, overwhelmed with information and paperwork, and feel underappreciated. Cheerful and charming, bearing food and gifts, drug reps provide respite and sympathy; they appreciate how hard doctor's lives are, and seem only to want to ease their burdens .... every word, every courtesy, every gift, and every piece of information provided is carefully crafted, not to assist doctors or patients, but to increase market share for targeted drugs."

A fascinating insight into part of the process of getting the drugs from the lab to you - read it, and also take a look at the Merck Training Guide which was unearthed as part of the Oversight and Government reform committee Hearing on Vioxx under Chairman Henry Waxman , Item 17 "Merck, Basic Training Participant Guide (Jan. 2002)." see excerpt (click to enlarge) at top of article of part of Page 63 detailing information available to the rep....whilst you are at it this Merck document is a fascinating insight into ...well read it and see.

This is particularly interesting in the light of subsequent events related to prescribing Vioxx.

FDA issue "Black Box" warning for Diabetes Type II drugs, Avandia and Actos

The Food and Drug Administration (FDA) have determined that a "black box" warning highlighting "may cause or worsen heart failure in certain patients" has to be added to thiazolidinedione class of type 2 diabetes drugs, including GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's / Eli Lilly Actos (pioglitazone). See this website for SKF/Avandia official response and here for Actos - July 30th Press Release from Takeda here.

This decision results from an FDA review of post-marketing reports that showed warning signs of heart failure found - significant weight gain and oedema, which associated with poor outcomes, including death, the agency added. This follows a "meta-analysis" published by Dr. Steven Nissen, chief cardiologist for the Cleveland Clinic, in the New England Journal of Medicine which detailed a major study showing inc reased risks of heart attacks, especially amongst Diabetes Type II patients without other signs or indicators of heart problems..

GlaxoSmithKline's Avandaryl (rosiglitazone plus glimepiride), Avandamet (rosiglitazone plus metformin), as well as Takeda's Duetact (pioglitazone plus glimepride) will also carry the new "black box" warning.

An advisory panel had earlier in June voted 22-1 to recommend that GlaxoSmithKline's type 2 diabetes drug, Avandia (rosiglitazone), should remain on the market, despite data suggesting that it increases cardiovascular risks. The panel had also recommended that the product's label should be updated with new safety warnings.The advisory panel had reviewed a 436-page report which was a compendium of reviews released in advance of an advisory panel hearing held on Monday June 30th.

In 2006 Avandia sales totalled $3 billion. Barbara Ryan, analyst for Deutsche Bank North America, said in a published report that US Avandia prescription volumes were down 50 % in the week ended July 20, compared to the week preceding May 18, when Nissen's article was published. For those same time periods, Actos US prescriptions were up 19 %. Glaxo shares rose 4% on Tuesday after the news.

Diabetes drugs to get stronger heart-failure warning - (Bloomberg)
FDA to strengthen diabetes drug warnings - (CNN)
GlaxoSmithKline Updates Prescribing Information for Avandia - (Pharmalive)

If you take Avandia or Actos you should inform yourself of the risks involved - Actos / Takeda / Lilly say "Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking ACTOS. " - I did and I spoke to the Doctor.

My Doctor says (God Bless her), "We are going to ignore the Nissen report".. what do you do ? Change Doctor, Flip a coin ? Fuller discussion of the Nissen report here in an earlier post.