Thursday, April 30, 2009

Merck Schering-Plough; something just hit something


A suspicious surge in trading of Schering-Plough Corp. sales just before news of its merger deal with fellow drugmaker Merck & Co. is being investigated by federal regulators, according to a published report.


The Securities and Exchange Commission is looking whether any trades were made by people with inside knowledge about the merger talks, unidentified people familiar with the situation told The Wall Street Journal on Thursday.

Preemption - quote of the week

The Supreme Court decision may cost the pharma industry “billions of dollars,” said attorney Mark Herrmann at Jones Day in Chicago, who defends companies in similar suits. “There’s no way to quantify it, but the number has as many zeroes in it as attacked Pearl Harbor.”

Bloomberg

How soon before Amylin and Lilly merge?

Amylin and Lilly will work together to develop and market a new delivery device for Byetta (exenatide), a treatment for type 2 diabetes.

Under the agreement, the two companies will cooperate on the development, manufacture and marketing of a pen device that patients can use to administer the drug on a once-weekly basis.

The pre-filled device will replace the syringe and vial used in clinical trials for the drug.

Lilly will provide 60 percent of the $216 million to develop the device, and Amylin will contribute 40 percent, according to a news release. Amylin will develop and manufacture the final pen product in the U.S. and manufacture unlabeled and unpackaged pans for non-U.S. markets. Amylin and Lilly will share U.S. sales and marketing rights, and Lilly will handle sales and marketing outside the U.S.

The companies also said they have begun a phase 1/2 clinical trial on an exenatide once-weekly suspension. The trial, using healthy volunteers and patients with type 2 diabetes, will examine the effectiveness, tolerability and safety of the formulation. It will begin in April and is expected to be completed by year-end.

San Diego-based Amylin (NASDAQ: AMLN) announced in May 2007 that it was expanding a previously announced facility on Trade Port Drive in West Chester to manufacture the long-acting release formulation of exenatide, marketed under the brand name Byetta. Amylin has cooperated with Indianapolis-based Lilly (NYSE: LLY) on the development of the drug.
Source

Damn straight!


Taking free lunches from company salespeople, giving paid lectures on their behalf and other practices ''erode public trust while providing no meaningful benefits to patients or society,'' Institute of Medicine panel chair Dr. Bernard Lo.


Bernard Lo, M.D. is Professor of Medicine and Director of the Program in Medical Ethics at the University of California, San Francisco. He is National Program Director for the Greenwall Faculty Scholars Program in Bioethics. He is co-chair of the Standards Working Group of the California Institute of Regenerative Medicine, which will recommend regulations for stem cell research funded by the state of California. He also serves on the Data and Safety Monitoring Committees for diabetes prevention trials and a HIV vaccine trial at NIAID. He is a member of the Ethics Working Group of the NIH-sponsorsed HIV Prevention Trials Network, which carries out clinical trials in developing countries. He is co-Director of the Policy and Ethics Core of the Center for AIDS Prevention Studies at UCSF, which provides technical advice and consultation to researchers carrying out clinical research, including research in resource-poor nations. He is a member of the Institute of Medicine (IOM) and serves on the IOM Council. He has been involved in a number of studies on ethical issues in human participants research carried out by the IOM and the National Academy of Science (NAS). He chaired a IOM panel on confidentiality in health services research. He developed a course on Responsible Conduct of Research that 120 postdoctoral fellows and junior faculty take each year. He also carries out research on ethical issues in human participants research, end-of-life decisions, and stem cell research. He is a practicing general internist and attends on the impatient medical service at UCSF.

Wednesday, April 29, 2009

"Ask your undertaker if Avandia is right for you!"

Ed Kavanagh writes

Here's Ed's blog: http://cube1986.blogspot.com/

Dr Dale Console - 1960

Some drugs that are aggressively peddled by pharmaceutical manufacturers may do more harm than good, and the facts that physicians need to know about them may be concealed for commercial reasons. These charges against the industry were made last week by two outspoken physicians, one with personal experience in the business, the other a university expert on its products.

Dr. Arthur Dale Console, 46, former medical research director for E. R. Squibb & Sons, told the Senate Antitrust Subcommittee (TIME, Dec. 21), chaired by Tennessee's Democrat Estes Kefauver, that many drugs of high price but low medicinal value are being foisted on doctors and patients. Dr. Console emphasized that he was testifying about the industry as a whole and not as a witness against Squibb. (After recurrent bouts with tuberculosis, he quit the company to go into private practice in Princeton, N.J.) Then Dr. Console declared: "The incidence of disease cannot be manipulated, so increased sales volume must depend at least in part on the use of drugs . . . improperly prescribed."

The industry. Dr. Console noted, wears a cloak of "self-proclaimed virtue" for its costly research activities, stressing "that there are many failures for each successful drug." But, he charged, "the problem is that they market so many of their failures."

Under present law, a new drug may be marketed, "if it cannot be shown that it probably will kill too many people." Reluctantly, Dr. Console concluded, he is convinced that sweeping reforms dictated by federal law are the only solution, because a company that tried to live up to higher ethical standards could not survive in today's competition.

The keenness of that competition was emphasized by Ohio State University's Professor (of pharmacology) Chauncey D. Leake, 63, who is also president of the American Association for the Advancement of Science. The drug companies, said Dr. Leake, treat the nation's physicians as "simpletons" by flooding them with "flamboyant, exaggerated advertisements." And "these ads conceal for commercial reasons what is really essential for physicians to know."

The 20,000 "detail men" (salesmen who call on doctors) seldom give the physician the scientific background necessary for wise use of a new drug. "If promotional efforts were simpler and more informative," Dr. Leake contended, drug prices could be cut.

Source: Time

Insider's view: nearly half a century later what has changed?

Other than the "detail man" is now more likely to be female and there are nearly five times more of them!

Well, it could be argued that the industry has found ways of manipulating the incidence of disease. Consider "disease mongering" and diagnostic aids.

Comments welcomed!

What's a "pharmapologist"?

This might help explain.

And this will explain things even more!

H1N1 contd. - ground zero?

Thanks to Harpy

FDA - pass the Tylenol

"We have optimism based, I think, on intense marketing,"

Among all patients taking the new generation of antipsychotic medication, children are most likely to suffer severe weight gain and metabolic disturbances.

But the use of these drugs to treat children has seen steep growth. Between 1990 and 2000, prescriptions for children and adolescents grew 160 percent, according to a 2005 study; other studies show they continued to grow briskly through the early 2000s.

Virtually all of that prescribing has been off-label. Among the atypical antipsychotics, only risperidone (marketed as Risperdal) has been approved by the Food and Drug Administration for use by children with schizophrenia. In June, the FDA will consider a petition by AstraZeneca for permission to promote the use of Seroquel by adolescents (ages 13 to 17) with schizophrenia and by younger kids (11 to 17) with bipolar disorder.

As the drugs have become more widely prescribed, however, many physicians have become increasingly alarmed.

More

Tuesday, April 28, 2009

Merck - Vioxx: it's harder to ask questions when your mouth is full

SALES representatives from the international pharmaceutical giant that produced anti-arthritis drug Vioxx wined and dined scores of doctors at some of the country's most expensive restaurants, including Melbourne's Flowerdrum, Circa the Prince and Jacques Reymond.

Documents tendered to the Federal Court as part of a class-action against US drug company Merck & Co and its Australian subsidiary Merck, Sharp and Dohme, reveal that sales and marketing staff spent thousands of dollars on meetings with medical specialists.

This included taking doctors out to restaurants, wineries and hotels across the country.
The internal 2001 Merck log titled "meetings held" showed sales staff spent up to $6000 on single meetings with doctors. Venues included Sydney's Taronga Zoo and Sheraton on the Park, the luxury Hydromajestic Hotel in the Blue Mountains and Melbourne's Aquarium.

With entries dated from March 2001 to December 2001, the log shows a number of doctors -- mostly rheumatologists -- were taken out up to three times each during that period. One arthritis specialist from Melbourne scored a meal at the Flowerdrum and Jaques Raymond within the space of a few weeks.

The document was tendered as part of the plaintiff's case against Merck. Lead plaintiff Graeme Peterson -- along with more than 1000 other Australians -- claims Vioxx caused him to have a heart attack in 2003 and is suing the company. He alleges Merck knew of the cardiovascular risks of the drug, but downplayed them before it was recalled in 2004.

Vioxx was launched in 1999, and at its height was used by 80million people worldwide, because it did not cause stomach problems, unlike other anti-inflammatory drugs.

Merck has already settled thousands of lawsuits in the US over the effects of Vioxx for $US4.85 billion ($6.9 billion), but has made no admission of guilt. The company is fighting the class action in Australia.

Other documents tendered to the court by the plaintiff reveal that Merck management in Asia and Australia were told not to "proactively" communicate the preliminary results of the VIGOR study in March 2000 after it found there was an increased risk of heart attacks among patients on Vioxx compared with another anti-inflammatory drug.

"Widespread communication/promotion of the preliminary results should not be undertaken at this time," the instruction said.

"This document should not be left with anyone outside the company. Discussions around VIGOR should NOT be proactively started with external customers at this time."

The document -- titled "Communication Strategy for VIGOR" -- was directed at the Asia-Pacific managing directors and instructs staff that if the topic of the research is brought up, "the emphasis" should be placed on positive findings on gastro-intestinal safety.

The Australian

Institute of Medicine tries to undo the ties that bind Big Pharma to MDs







Millions of dollars in gifts, travel and consulting fees from the pharmaceutical industry should be eliminated to stop companies from influencing how doctors practice medicine, a report by the government's top medical advisers says.

The sweeping recommendations from the Institute of Medicine call on medical professionals — from university professors to family doctors — to shun financial arrangements with companies that have flourished over the past three decades.

Taking free lunches from company salespeople, giving paid lectures on their behalf and other practices "erode public trust while providing no meaningful benefits to patients or society," institute panel chair Dr. Bernard Lo said in a statement.

The report calls on medical schools, hospitals and physician groups to:

• publicly report funding they receive from companies.

• not accept free meals, gifts or other items from companies.

• prohibit doctors who have a financial conflicts of interest from testing new therapies on people.

The 353-page document arrives as state and federal lawmakers bolster efforts to require companies to publicly report the money they spend courting physicians. The report could give them more leverage in their push to untangle the knotty relationships between industry and physicians, which some say drive up the cost of medicine.

More

MeReC Bulletin on COPD

The UK's National Prescribing Centre (NPC) has published a MeReC Bulletin (PDF) that discusses recent safety issues with inhaled treatments for chronic obstructive pulmonary disease (COPD).

Hat tip: http://www.prescriber.org.uk/

“Tried-and-true is better than latest-and-greatest"

70% of consumers in 11 countries say they would prefer to take a drug that has been around for a while, rather than one which is the latest in its field, even though 50% believe that medicines today are more effective than they were five years ago.

The root cause of this discovery, that “tried-and-true is better than latest-and-greatest,” is likely to be the frequently negative “media swirl” surrounding the industry and its products, coupled with increasing distrust in authorities and institutions around the world, says the study, which is produced by advertising agency DDB Worldwide and entitled Health is the New Wealth. The finding is also in conflict with the pharmaceutical industry’s mission to discover and provide breakthrough therapies, it adds.

Italy cut drug budget to help fund earthquake disaster

The Italian medicines agency AIFA and the business federation Farmindustria have expressed deep concern about the decision by the Italian government to cut the pharma budget and use the resources for funding relief for the earthquake in Abruzzo.

Ministers have drafted a decree to provide funding for the area affected. One of the measures is a reduction of €400m in the amount the national health services can spend on medicines distributed through pharmacies in 2009.


More

Alizyme's Charman steps down

Sir Brian Richards has said he wants to step down as chairman of listed Cambridge drugs company Alizyme, a position he has held since the business was founded. His place will be taken by Alan Goodman, who has joined the board and will take over as chairman in July.

Gaviscon - what a feeling!

Novartis - Ritalin: just wait until pushy parents read this!

Children on medicine for attention deficit disorder scored higher on academic tests than their unmedicated peers in the first large, long-term study suggesting this kind of benefit from the widely used drugs.

The US nationally representative study involved nearly 600 children with attention deficit hyperactivity disorder followed from kindergarten through fifth grade.

Children's scores on several standardized math and reading tests taken during those years were examined. Compared with unmedicated kids, average scores for medicated children were almost three points higher in math and more than five points higher in reading. The difference amounts to about three months ahead in reading and two months in math, the researchers said.

Both groups had lower scores on average than a separate group of children without ADHD. The researchers acknowledged that gap but said the benefits for medicated youngsters were still notable.

More

Arena slim down dramatically

Arena Pharmaceuticals is to lay off 31 percent, or 130 employees, before June 22, the company told the SEC. Arena staffers — whose future is dependent on an anti-obesity drug, lorcaserin – may be forgiven for wondering how it has all gone wrong so quickly.

Jim Edwards has more

H1 N1 contd.


Damn right

"Most of the things worth doing in the world had been declared impossible before they were done."

-Louis D. Brandeis  

Pfizer - Chantix: don't mention the side effects!


A Pfizer promotional campaign for the controversial drug Chantix - which includes financing a course for doctors through the University of Wisconsin-Madison - has helped the drug dominate the prescription smoking-treatment market while burying mention of its serious side effects.

Chantix now accounts for 90% of smoking cessation prescriptions, even though the Food and Drug Administration has been investigating the drug for a rash of serious side effects, such as suicidal behavior and blackouts.

None of the side effects are mentioned in the UW continuing education online course, which is paid for by Pfizer. The course directly mentions only Chantix as a first-line treatment, even though the drug is one of seven first-line treatments, according to national guidelines.

Further, organizations such as the Department of Veterans Affairs, say Chantix should not be considered as a first-line treatment.

More

Monday, April 27, 2009

Pfizer and Corey Goodman - anyone know the story?


Pfizer said that Corey Goodman, a senior vice president hired 19 months ago to lead Pfizer’s biotechnology center in California, has resigned.

Pfizer gave no reason for Goodman’s departure in a filing with the U.S. Securities and Exchange Commission today. Goodman held the title of president of Pfizer’s Biotherapeutics and Bioinnovation Center in South San Francisco, California. His resignation is effective May 31.

More

Deadlines -

ain't they a bitch?!

Plan B = Morning After

Story

Sunday, April 26, 2009

Cosmetic neurology



Brain Gain - The New Yorker article
Hat tip: http://www.bookofjoe.com/

H1N1

"Mergers and Acquisitions in the Pharmaceuticals Sector, 2009 - Critical success factors for competing in a consolidating market"

"2009 is set to redefine the structure and dynamics of the pharmaceutical industry in a way not seen since the year 2000"


Background


On 26th January 2009, Pfizer announced plans to acquire Wyeth for $68 billion. Pfizer’s CEO, Jeffrey B Kindler, insisted the deal would be different from the company’s earlier mega-deals involving the acquisitions of Pharmacia (2002) and Warner-Lambert (2000) – the acquisition of Wyeth would provide a broad and diversified portfolio, rather than been focused on a single product or cost-cutting. Pfizer’s strategy of growing its portfolio through a mega M&A deals follows the 2008 acquisitions of Millennium by Takeda and ImClone by Eli Lilly.


These major deals are likely to result in two alternative industry responses:


a wave of consolidation involving further mega-deals;


the emergence of independent players that continue to build their portfolios through internal development, licensing and smaller scale acquisitions.

Leading pharmaceutical and biotechnology companies must decide how best to respond Pfizer’s proposition that ‘size matters’. Those that choose to consolidate will have to identify the best prospects, consolidate portfolios and execute synergy cost savings. Those that choose not to embark down the mega-deal path will still have to adapt to a more consolidated world in which broad, diverse portfolios and an efficient cost base or a minimum requirement to compete.


Report Purpose

Mergers and Acquisitions in the Pharmaceuticals Sector, 2009 - Critical success factors for competing in a consolidating market from URCH Publishing, explores the merits of the mega-deal in contrast to a more measured portfolio growth strategy and highlights the key opportunities and challenges presented by both business models. A detailed assessment of recent deals will identify the key issues and success factors, while the future M&A strategies of the leading pharmaceutical and biotechnology companies will also be assessed. Finally, the impact of consolidation in the industry will evaluated both at the organizational and therapeutic market level. All companies, big and small will be affected by the shake-up. This report will help to understand the key opportunities and challenges that lie ahead in order to formulate a robust response to a changing competitive landscape.


Some key findings from the report


Significant industry consolidation will lead to a fundamental shift in the market dynamics across all major product categories.


Since the beginning of 2006 a total of seven deals have been agreed with total transaction fees in excess of US$10 billion.


It appears likely that the mega-M&A wave started by the 3 deals in Q109 is not yet finished.


A handful of major players will follow in the footsteps of Pfizer and enter into major M&A transactions involving a significant step change in market shares and industry consolidation.


Reasons to buy this report


Understand the M&A environment in the pharmaceuticals industry.


Be informed about likely mergers and analyse companies that could be acquired in the near future


Assess the success factors that underlie a successful acquisition and review those which have delivered long-term shareholder value.


Draw on advice to manage your company to compete in an increasingly consolidated marketplace.


Gain insight into how drug portfolios are managed in an M&A situation and best value is extracted.


Buy it here.

$3,000! for 111 pages.

PharmaGossip is free!


Saturday, April 25, 2009

FDA - "all hands meeting" Wednesday

An unusual internal meeting scheduled for Wednesday at the Food and Drug Administration may signal how agency officials intend to handle the many controversies swirling around its embattled device division.

Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, sent an e-mail message on April 10 announcing an “all-hands meeting” to discuss the strategic direction of the device center. Such a broad-based meeting that includes all scientists within the device evaluation office has not been held for years, two agency officials said.

Nine dissident scientists signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers.

More

Can't wait!

I kid you not!


Friday, April 24, 2009

Merck - Vioxx: All together now!

SALES and marketing staff from an international pharmaceutical company who manufactured anti-arthritis drug Vioxx produced a song to "Ricky Martin-type" music titled "Go Vioxx" to help encourage their sales representatives.

In a draft marketing document tendered to the Federal Court as part of a class-action against Merck & Co, the song is part of a "Vioxx Sales Driver Vol 1" CD for staff at the Australian company.

"Go Vioxx, Go Vioxx, Go Vioxx," one verse states. "Just one day is all you need/To kick the situation/And lose all the agony of pain and inflammation ... The moral of the story is that/Celebrex (their opposition) will fight us/ For the crucial market share/Of Osteoarthritis."

The song also includes a verse about an ageing Russian soldier, complete with the side-effects "(insert a guttural Russian sound)".

"His life was changed though Vioxx/He'll be jumping' round for joy till/A doctor tries to write a script for/Some old non-steroidal," it reads. "Sell Vioxx for me baby/Sell Vioxx for me baby/Sell Vioxx for me baby/Sell Vioxx for me baby!"

The draft transcript of the CD, with written amendments scribbled all over it, was lodged as part of the plaintiff's case against US company Merck & Co and its Australian subsidiary, Merck Sharpe and Dohme.

Lead plaintiff Graeme Peterson, along with more than 1000 other Australians, claims Vioxx caused him to have a heart attack in December 2003 and alleges Merck played down the cardiovascular risks of the drug in the years before it was voluntarily withdrawn in 2004.

Another song detailed in the document is one done to a "Paul Kelly-style rock song".

"I used to dream of the days/When I climbed any mountain/Or walked all the way to St Kilda from town," it reads. "But time marched on and left me with this/Pain and inflammation/The best days of my life just seemed to/Fade and bring me down. Vioxx you gave me a chance to start over/And now the best days are here to stay."

The transcript also has "team talk back" where sales representatives discuss the issues they are facing, including how to deal with the "cardiovascular issue".

The last sentence of the transcript reads: "This brings us to the end of our first sales driver. I certainly hope you found it enjoyable ... Don't forget the Vioxx Victories hotline, it's number 8100 -- we're dying to hear 'bout all of your Vioxx victories so happy selling."

Merck has already settled thousands of lawsuits in the US over the effects of Vioxx for $US4.85 billion (AUS$6.8 billion), but has made no admission of guilt.

The trial continues.

The Australian

AstraZeneca - Damn the torpedoes, full speed . .......BANG!


Damn the torpedoes, full speed ahead. Rear Admiral David Farragut's order to the Union fleet upon entering mine-strewn Mobile Bay could just as well be the rallying cry for AstraZeneca, the UK drugmaker.


Like its bigger rival, GlaxoSmithKline, AZ intends to sit out the industry’s round of mega-mergers. Already the world’s fifth biggest drugmaker by market capitalisation, and with plans for 15,000 job cuts by 2013, it sees few benefits to greater scale.

Furthermore, unlike its rivals, AZ has also avoided diversifying beyond its research-driven business model. Rather than move into dermatology treatments, like GSK, or eyecare, like Novartis, AZ wants to make up for a dearth of promising new drugs by improving research and development.

That is risky.

Drug development is getting harder and more expensive. Moreover, AZ faces the biggest patent cliff of any of its peers. By 2014, expiring patents could chop 30 per cent off this year’s forecast $30.5bn in sales, Credit Suisse estimates.

More at FT

Thursday, April 23, 2009

Bonjela for kids - OK in Ireland; banned in the UK


The Irish Medicines Board says it is safe for parents to continue using Bonjela as a teething gel despite a health warning in the UK that certain types of the product shouldn't be given to children under 16.

British health regulators say there is a small chance that the salicylate ulcer gel could lead to a rare syndrome (Reyes) that can cause liver and brain damage.

However, the Irish Medicines Board says it has done its own review and is satisfied that parents can continue to use the product to soothe baby's gums.

Begorrah!

BMS - Onglyza: three more months

U.S. regulators need more time to review the new diabetes drug Onglyza from AstraZeneca and Bristol-Myers Squibb.

The FDA has delayed a decision on whether the product should be approved by three months to July 30th.

"Pessimism of the intellect, optimism of the will"


Big Pharma is in the throes of convulsive change. A spate of multibillion mergers and acquisitions in the past few months is transforming the landscape, with this week's $3.6bn (£2.5bn) takeover of Stiefel by GlaxoSmithKline the latest and certainly not the last.

It's a truism among analysts that this huge restructuring is driven, primarily, by a dearth of new blockbusting drugs in the pipeline of the biggest pharma groups, which are being forced to buy up innovation via smart start-ups and/or generic drugs companies.

But on the day GSK made its latest foray under its new chief Andrew Whitty, Wolfgang Plischke, board member for innovation, technology and environment at Bayer, pointed to a deeper set of trends. Over lunch in the German group's HQ overlooking a Japanese water garden, we discussed a growing public distaste for, nay dislike of, science and a "war for scarce talent" as young people turned their backs on it.

"I don't expect there'll be a change in public opinion in the next five to 10 years," he said.

But echoing the famous aphorism of the Italian Marxist Antonio Gramsci – "pessimism of the intellect, optimism of the will" – Plischke, an ultra-lean 57-year-old biologist keen on endurance sports, is convinced the industry – and science – can overcome their poor reputation and image.

More

Coast IRB close

Good!

Clot Wars contd. - Xarelto vs Pradaxa, FIGHT!

Back stories here.

The UK's NICE has approved Bayer's anti-clotting treatment Xarelto, bringing it into line with Boehringer Ingelheim's rival Pradaxa.

Xarelto (rivaroxaban) was assessed under NICE's rapid single technology appraisal work programme and found to be a cost effective option for preventing blood clots.

The drug was launched in the UK last year and Bayer predicts it could reach blockbuster status with sales of more than 2 billion euros ($2.8 billion).

Both Xarelto and Pradaxa are indicated for the prevention of venous thrombembolic events (VTE) in adults who have undergone hip or knee replacements.

More

PharmaGossip - "very good", official!


Pharma Gossip at Blogged

New NICE guidance

The UK's National Institute of Health and Clinical Excellence has published new guidance for the month of April.

There are two guidelines that may impact on primary care, a clinical guideline on diarrhoea and vomiting in children under 5 and another clinical guideline on glaucoma.

The former guidelines covers the diagnosis, assessment of dehydration, fluid management, nutritional management and the role of antibiotics and other therapies in treating diarrhoea and vomiting in children under 5. The guideline also dispels the commonly held view that sugary drinks such as flat cola and lemonade aids in recovery; in fact this strategy may worsen symptoms. This aspect of the guidance has been widely reported in the media (BBC).

The latter guideline details the diagnosistreatment and care of:

  • adults with a diagnosis of the condition known as chronic open angle glaucoma
  • adults with a diagnosis of ocular hypertension
  • adults who are at a high risk of developing glaucoma

The myth of the bipolar child contd. - Jerome Groopman's 2007 "must read" article

Phillip Blumberg, a psychotherapist in Manhattan, told me, “Psychological diagnosis is, in essence, a story. If you have a mood disorder, there is the fear, the shame, and the confusion—the stigma— associated with it, so you want to grab on to the most concrete and clear story you can. There is something about the clarity of bipolar disease, particularly its biological basis, which is incredibly soothing and seductive.”

Blumberg, who for two years was a vice-president at ABC Motion Pictures, believes that advertising by pharmaceutical companies has influenced the public’s view of bipolar disorder.

(Eli Lilly, in particular, has come under fire for its marketing practices. The drug company is currently the subject of lawsuits that claim that the company attempted to hide Zyprexa’s side effects, and promoted the drug for off-label uses. Lilly has denied the accusations.)

Blumberg described recent ads, for drugs like Zyprexa, that include a list of symptoms characteristic of the disorder. “But, of course, we all have these symptoms,” he said. “Sometimes we’re irritable. Sometimes we’re excited and elated, and we don’t know why. With every form of advertising, the first goal is to make people feel insecure. Usually, they are made to feel insecure about their smell or their looks. Now we are beginning to see this in psychiatric advertising. The advertisements make frenetic, driven parents feel insecure about the behavior of their children.”

Blumberg noted that he had seen instances of the disorder in some children, and that it was a real and serious diagnosis. But he also cited the mounting pressure on children, particularly in the middle and upper classes, to succeed, first at private or selective public schools, and then at exclusive colleges and universities.

“These kids become very well turned-out products,” he said. “They live to have résumés. They don’t have résumés because they live.” Parents may fear that children who behave in an eccentric way are at a disadvantage, and in turn pressure the pediatrician or the psychiatrist to come up with a diagnosis and offer a treatment. “Then an industry grows up around it. This, then, enters as truth in the popular imagination.”

Read the whole article here.

A shrinking market? - Matt Herper writes

The global pharmaceutical market, measured in dollars, will shrink in 2009 for the first time in 25 years, according to a new report.

Sales of medicines will generate between $750 billion and $760 billion this year, according to a revised forecast from research firm IMS Health, down from $773 billion in 2008.

More

EHC - the FDA move to Plan B

The Food and Drug Administration announced Wednesday that it would allow 17-year-olds to buy the emergency contraceptive pill Plan B without a prescription, signaling a major shift in the agency's approach to a long-simmering issue.

The decision follows a ruling last month by a federal judge who rejected a Bush administration policy that allowed non-prescription sales of the pill only to people 18 or older, requiring younger girls to consult a doctor before they could get it.

More at the Trib

Wednesday, April 22, 2009

Merck - Vioxx: remember Dr Briggs Morrison?

Back story.

THE drug company Merck had a cardiologist sign his name to a medical journal article it wrote claiming there was no evidence of any heart risk attached to its drug Vioxx, court documents allegedly show.

In an internal email in August 2001 to discuss a draft of the manuscript, a Merck senior researcher, Briggs Morrison, expressed concern about the claim that Vioxx was not associated with an increased risk of cardiovascular events.

"That seems wishful thinking, not a critical interpretation of the data," Dr Morrison said in an email to colleagues. "The data appears to have been interpreted to support a pre-conceived hypothesis."

The claim was nonetheless included in the final version of the article, which was sent by Merck to the US cardiologist Dr Marvin Konstam for approval.

Dr Konstam was named as the lead author of the article, published in the medical journal Circulation in October 2001. Five of the authors were Merck employees and the other two, including Dr Konstam, were paid consultants.

The email was tendered to the Federal Court yesterday as part of a class action on behalf of every Australian who had cardiovascular conditions after completing at least one prescription of Vioxx between June 30, 1999 and its worldwide recall in 2004. The class action, which includes more than 1000 people, alleges Merck covered up a higher risk of cardiovascular conditions.

More

Roche - Avastin: clinical trials, ain't they a bitch?

The drug Avastin failed to prevent colon cancer from recurring by a significant amount in a clinical trial, the drug’s manufacturer, Genentech, said early Wednesday.

The results of the trial had been closely watched because a success would have paved the way to a new use of the drug, potentially increasing sales by billions of dollars a year.

Now those efforts will be set back, and it appears that Roche, the pharmaceutical company based in Basel, Switzerland, may have paid more than it needed to acquire Genentech in March. Roche shares fell 10 percent in early trading in Europe.

More at NYT

Introducing the PharmaScold Blog!

What's a PharmaScold??

Wikipedia:

The term pharmascold refers to prominent critics who “routinely vilify the medical products industry and portray academics working with it as traitors and sellouts” [1]. The verb form “to pharmascold’’’ means to engage in pharmascold activity. When it occurs in the mainstream press, pharmascolding is considered a form of tabloid journalism[2].

Pharmascolding differs from neutral criticisms of medical-industry/academic relationships in several ways. Pharmascolding is often self righteous in its condemnation of alleged corruption and inaccurate in its presentation of facts[3]. The pharmascold sensationalizes the issue of industry-academic relationships by focusing on topics that are likely to evoke emotions in readers. For example, child psychiatry is a frequent target of pharmascolding because doctors can be portrayed as harming defenseless children[4][5][6][7][8]. The pharmascold often will choose one or more individuals as [scapegoats] who they accuse of corruption and collusion with the medical industry[9].

Pharmascolding journalists typically uses methods akin to those used in yellow journalism and the tabloid press . Their use of undocumented accusations has been described as McCarthyism, especially when the accusations have been made by elected officials[10]. By using the selective citation of unverified “facts,” pharmascolds create a cloud of innuendo over their [scapegoats]. The reasons for pharmascolding have not been well studied. Pharmascolds may benefit personally, as in the case of a journalist who uses pharmascolding to attract readers because sensational articles can increase readership. Politicians use pharmascolding to satisfy a special interest group, shore up populist support, or distract the public from other issues.

The pharmascolding journalist publishes articles that criticize medical companies or their products. They highlight deficiencies of these products while ignoring their benefits. The pharmascold article does not have a neutral point of view and the “facts” cited are either invented or from a single source that has not been checked for accuracy. Pharmascolding is not limited to the tabloid press. A well documented example of pharmascold activity is in the New York Times. As an example, in 2005, one article reported that a drug commonly used to treat attention deficit hyperactivity disorder in children, might increase the risk for cancer later in life [11]. His report was based on a single, small study [12], which had been criticized [13]. When subsequent studies refuted the initial report [14], [15], [16], this was not reported by the [New York Times]. This type of selective reporting is characteristic of pharmascold activity. Another pharmascold feature of the article is the use of innuendo. It reports that Dr. Greenhill was skeptical about the study suggesting Ritalin causes cancer and then states he had been a consultant to the pharmaceutical industry. Althought this latter comment is true, its placement, through innuendo implies that Dr. Greenhill’s position might be influenced by pharmaceutical funding. In contrast, there is no discussion of the potential conflicts of interest of those who disagreed with Dr. Greenhill.

Additional pharmascold activity has been documented in criticisms of the drug Avandia [17], criticisms of Dr. Fredrick Goodwin’s relationships with pharmaceutical companies [18], criticism of RU-486 [19] and what Dr. Robert Goldberg refers to as “the McCarthyite Mugging of Joe Biederman” by the New York Times[20]. Dr. Goldberg describes the Times’ article as a form of McCarthyism because it repeats accusations against a U.S. citizen made by a United States Senator, without verifying the validity of the accusations using another source. In fact, Dr. Biederman had rebutted the criticisms of his work in a letter to the [New York Times] that the Times did not publish[21].

Each of these example shares core features of pharmascolding: they use innuendo and selective reporting and do not verify accusations. The New York Times’ articles about Joseph Biederman and Frederick Goodwin are notable for the pairing of an article on the topic with an Editorial implying that these doctors were shills for pharmaceutical companies [22]. This is accomplished by rehashing the accusations made in the news article under with an Editorial entitled “Expert or Shill?”.

Although pharmascold activity is rare in academic journals, it does occur. One example comes from Nature Neuroscience, which published an editorial which claimed there was a “credibility crisis” in child psychiatry because Dr. Joseph Biederman had been accused of not declaring over a million dollars in income he had received from pharmaceutical companies [23]. This article is instructive because it uses mere accusation to declare a “crisis” situation rather than seeking to determine if the accused is indeed guilty. Nature Neuroscience subsequently published Dr. Biederman’s response enumerating the errors made in their Editorial [24].

Scapegoats of pharmascolding are at a disadvantage because, by definition, pharmascolds are prominent placed critics who have access to media outlets denied to the scapegoat. The Biederman affair is instructive. The New York Times has pharmascolded Dr. Biederman on their front page and on their editorial page. His only option to respond would be a Letter to the Editor, which the Times requires to be 150 words or less [25]. Nature Neuroscience’s pharmascolding editorial about Dr. Biederman [26] was prominently displayed but Dr. Biederman’s response [27] was published as a short letter in the back pages the publication. Pharmascolding can also be countered in the blogosphere but such responses may not be viewed as having the same credibility as prominent newspapers and academic journals.

Professional organizations can reduce pharmascold activity in the ethical codes they transmit to professionals and students. For example, the Code of Ethics of the
Society of Professional Journalists (SPJ), warns against the use of innuendo when stating that journalists should "make certain that headlines, news teases and promotional material, photos, video, audio, graphics, sound bites and quotations do not misrepresent. They should not oversimplify or highlight incidents out of context." [28]. The SPJ Code of Ethics clearly prohibits scapegoating by stating that journalists should: “Show compassion for those who may be affected adversely by news coverage.” It also cautions journalists to “Test the accuracy of information from all sources and exercise care to avoid inadvertent error.” [29].

Because pharmascolding seeks to limit contacts between academic medicine and the medical industry is said to stifle innovation in the development of new therapeutics[30]. In this view, society benefits most from the free exchange of scientific and medical information. When medical experts are discouraged from working with industry, the best ideas may not always reach the public. Because innovation frequently improves care and reduces cost, it is also relevant to health care reform in the United States. Critics of this point of view argue that pharmascolding prevents conflict of interest situations in which doctors are paid by the medical industry for their ideas. The debate centers on the effects of these payments. Do they encourage innovation by attracting newer and better ideas into the medical industry? Or, do they unduly influence doctors to make wrong decisions? That is the crux of the debate.

References
^ http://online.wsj.com/article/SB123914780537299005.html
^ Sanders, K. Ethics and Journalism. SAGE Press, 2003
^ http://online.wsj.com/article/SB123914780537299005.html
^ http://online.wsj.com/article/SB123914780537299005.html
^ http://www.nytimes.com/2005/07/01/health/01ritalin.html?_r=1&scp=4&sq=harris%20ritalin&st=cse
^ http://www.healthcentral.com/bipolar/c/15/50902/frederick-goodwin-ny
^ http://www.cjr.org/politics/partisan_infection_strikes_med.php
^ http://www.drugwonks.com/account_blog/row?_method=get&eid=789c52d2dc72851406c281b9eeab8ffc&id=6150
^ Greenberg, S. ‘’Tabloid Journalism’’. Greenwood Press, 1966
^ Hargreaves, I. ‘’Journalism: Truth or Dare?’’
^ http://www.nytimes.com/2005/07/01/health/01ritalin.html?_r=1&scp=4&sq=harris%20ritalin&st=cse
^ El-Zein, R. A., Hay, M. J., Lopez, M. S., Bondy, M. L., Morris, D. L., Legator, M. S. & Abdel-Rahman, S. Z. (2006). Response to comments on 'Cytogenetic effects in children treated with methylphenidate' by El-Zein et al. Cancer Lett 231, 146-8.
^ Preston, R. J., Kollins, S. H., Swanson, J. M., Greenhill, L. L., Wigal, T., Elliott, G. R. & Vitiello, B. (2005). Comments on 'Cytogenetic effects in children treated with methylphenidate' by El-Zein et al. Cancer Lett 230, 292-4.
^ Witt, K. L., Shelby, M. D., Itchon-Ramos, N., Faircloth, M., Kissling, G. E., Chrisman, A. K., Ravi, H., Murli, H., Mattison, D. R. & Kollins, S. H. (2008). Methylphenidate and amphetamine do not induce cytogenetic damage in lymphocytes of children with ADHD. J Am Acad Child Adolesc Psychiatry 47, 1375-83.
^ Walitza, S., Werner, B., Romanos, M., Warnke, A., Gerlach, M. & Stopper, H. (2007). Does methylphenidate cause a cytogenetic effect in children with attention deficit hyperactivity disorder? Environ Health Perspect 115, 936-40.
^ Holtmann, M., Kaina, B. & Poustka, F. (2006). [Methylphenidate-induced cytogenetic alterations?]. Z Kinder Jugendpsychiatr Psychother 34, 215-20.
^ http://www.stats.org/stories/2007/nyt_mislead_avandia_sept12_07.htm
^ http://www.healthcentral.com/bipolar/c/15/50902/frederick-goodwin-ny
^ http://www.cjr.org/politics/partisan_infection_strikes_med.php
^ http://www.drugwonks.com/account_blog/row?_method=get&eid=789c52d2dc72851406c281b9eeab8ffc&id=6150
^ http://www2.massgeneral.org/pediatricpsych/publications/Letter%20to%20the%20Public%20Editor.pdf
^ http://www.nytimes.com/2008/11/30/opinion/30sun2.html
^ Editoral (2008). Credibility crisis in pediatric psychiatry. Nat Neurosci 11, 983.
^ Biederman, J. (2008). Credibility crisis in pediatric psychiatry. Nat Neurosci 11, 1233.
^ http://www.nytimes.com/ref/membercenter/help/lettertoeditor.html
^ Editoral (2008). Credibility crisis in pediatric psychiatry. Nat Neurosci 11, 983.
^ Biederman, J. (2008). Credibility crisis in pediatric psychiatry. Nat Neurosci 11, 1233.
^ [1]
^ [2]
^ http://online.wsj.com/article/SB123914780537299005.html

Insider's view: nice writing - the style is familiar, is it yours Peter Pitts?

Oh, by the way Insider has the "PharmaScold Blog" in his portfolio: http://pharmascold.blogspot.com/

Pharma's Market with Mike Huckman - Lilly












What do Barrack Obama, Caroline Kennedy, Newt Gingrich and Sarah Palin have in common?

Go here to find out!

Cervix Wars contd. - Showdown at HPV2009, Malmö, Sweden


Back stories here.

But which is better? Gardasil or Cervarix? Fight! (only understood by Dr. Harry Hill fans!)

GlaxoSmithKline will release the first study to compare its cervical cancer vaccine with Merck’s blockbuster Gardasil, more than a year after completing the research.

Sales for Glaxo’s Cervarix amount to less than 10 percent of those garnered by Merck’s similar vaccine. The comparison study may influence which vaccine doctors use and insurers pay for. It will be presented for the first time at HPV2009 in Malmö, Sweden on May 10, according to a draft of the program obtained by Bloomberg News.

The study also will help governments determine which of the vaccines to select for immunizing women, influencing a global market that Glaxo estimated at more than $10 billion last year.

Glaxo’s shot, used less often than Gardasil in Europe, hasn’t won approval in the U.S., where Merck began selling its version three years ago.

Glaxo’s decision to wait 14 months to release the data and pick a little-known medical meeting as the venue “certainly has both my eyebrows up,” said Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, in Philadelphia.

“Half the world is waiting to see which vaccine is the better one,” Caplan said. “You have a huge ethical obligation to get information out quickly. I’m never a fan of releasing key findings on a highly contentious issue, such as who’s got the better vaccine, at a relatively unknown meeting.”
Hmmm! Wonder what the results might show?

Tuesday, April 21, 2009

Dr Harry Hill asks......

Playboy does waterboarding!

GSK - ALLI: today the UK, tomorrow Europe


GSK has announced that alli - the weight loss treatment that could help adults with BMI of 28 kg/m2 or more, lose 50 per cent more weight than by dieting alone - goes on sale today in pharmacies throughout the UK, and in markets throughout Europe during April and May.

For every 2 kilos lost using a reduced calorie, lower-fat diet, an extra 1 kilo could be lost by using alli.

This product launch has gained significant media attention (BBC).

Each Alli® capsule contains 60mg of orlistat and is recommended for people who are overweight (BMI > 28), want to lose weight, and will commit to healthier eating. The product is expected to retail for approximately £50 ($70) for a months supply.

More
Find out what "A-L-L-I" stands for here.