GlaxoSmithKline (GSK) has introduced a company car scheme for its 1,500 sales staff after a car allowance proved too expensive.
GSK found that, as manufacturers raised prices, the cost to employees of buying cars through the scheme also rose. The increase in VAT caused employer’s national insurance to also go up.
Harsha Modha, director of UK benefits at GSK, said: “We have not got the money to spend on the scheme, so we asked what we could do to make it cost-effective while addressing health and safety issues and making it attractive to sales staff. We ended up going back to the traditional company car model."
This arrangement posed a variety of risks, including whether employees were meeting health and safety standards, whether they had insurance in place, and whether they were keeping the car properly maintained. Modha added: “With our staff who use their car specifically to do their job, it is in our interest to make sure that they are driving a reasonable car that meets these criteria.”
The new scheme was launched on 3 October. In the first few days, there were over 1,400 quotes on the website. In the first week, there were 20 confirmed orders.
GSK began communicating the scheme by founding an employee representative forum, a group of five or six sales employees who were also involved in the development of the policy. The firm worked with the forum reps on a communication plan, which included an email campaign and employee survey to garner suggestions.
Modha added: “We will continue to get together every three months to make sure the scheme is still valued by employees and where we decide to make changes we will make them.”
Monday, October 31, 2011
GlaxoSmithKline UK introduces company car scheme
Pharmaceutical groups sued over thalidomide - FT.com
GlaxoSmithKline and Sanofi are being sued alongside Grünenthal by Americans born half a century ago with birth defects they allege were caused by the drug thalidomide, in a fresh twist that draws new pharmaceutical groups to the long search for responsibility.
Thirteen plaintiffs claim SmithKlineFrench, a precursor company to GSK, conducted tests in animals and clinical trials in humans in the late 1950s without adequate consent that led to at least one case of disablement which was never publicly revealed.
Goldman Sachs and Occupy Wall Street's Bank: The Real Story
Goldman's circuits blew when the credit union's management appeared in Zuccotti Park to endorse Occupy Wall Street's call to "Move Your Money" from commercial banks to community credit unions. Heeding Peoples' and Occupy's call, 23 protesters marched to their local Citibank branches to close their accounts - and were promptly arrested.
Sunday, October 30, 2011
Medtronic Insulin pump hack delivers fatal dosage over the air • The Register
With this device I created and the software I created, I could actually instruct the pump to perform all manner of commands," Jack told The Register. "I could make it dispense its entire reservoir of insulin, which is about 300 units. I just scan for any devices in the vicinity and they will respond with the serial number of the device.
Traders talk back to Occupy Chicago | The Daily Caller
We are Wall Street. It’s our job to make money. Whether it’s a commodity, stock, bond, or some hypothetical piece of fake paper, it doesn’t matter. We would trade baseball cards if it were profitable. I didn’t hear America complaining when the market was roaring to 14,000 and everyone’s 401k doubled every 3 years. Just like gambling, its not a problem until you lose. I’ve never heard of anyone going to Gamblers Anonymous because they won too much in Vegas.
Well now the market crapped out, & even though it has come back somewhat, the government and the average Joes are still looking for a scapegoat. God knows there has to be one for everything. Well, here we are.
Go ahead and continue to take us down, but you’re only going to hurt yourselves. What’s going to happen when we can’t find jobs on the Street anymore? Guess what: We’re going to take yours. We get up at 5am & work until 10pm or later. We’re used to not getting up to pee when we have a position. We don’t take an hour or more for a lunch break. We don’t demand a union. We don’t retire at 50 with a pension. We eat what we kill, and when the only thing left to eat is on your dinner plates, we’ll eat that.
For years teachers and other unionized labor have had us fooled. We were too busy working to notice. Do you really think that we are incapable of teaching 3rd graders and doing landscaping? We’re going to take your cushy jobs with tenure and 4 months off a year and whine just like you that we are so-o-o-o underpaid for building the youth of America. Say goodbye to your overtime, and double time and a half. I’ll be hitting grounders to the high school baseball team for $5k extra a summer, thank you very much.
So now that we’re going to be making $85k a year without upside, Joe Mainstreet is going to have his revenge, right? Wrong! Guess what: we’re going to stop buying the new 80k car, we aren’t going to leave the 35 percent tip at our business dinners anymore. No more free rides on our backs. We’re going to landscape our own back yards, wash our cars with a garden hose in our driveways. Our money was your money. You spent it. When our money dries up, so does yours.
The difference is, you lived off of it, we rejoiced in it. The Obama administration and the Democratic National Committee might get their way and knock us off the top of the pyramid, but it’s really going to hurt like hell for them when our fat a**es land directly on the middle class of America and knock them to the bottom.
We aren’t dinosaurs. We are smarter and more vicious than that, and we are going to survive. The question is, now that Obama & his administration are making Joe Mainstreet our food supply…will he? and will they?”
Read more: http://dailycaller.com/2011/10/28/traders-talk-back-to-occupy-chicago/#ixzz1c...
Saturday, October 29, 2011
Friday, October 28, 2011
'Big Pharma' wins investigative reporting honor - Pittsburgh Business Times
'Big Pharma's Deep Pockets' is a classic example of public service enterprise reporting," the judges wrote. "Through data made public as part of a Justice Department lawsuit, the Pittsburgh Business Times disclosed that area physicians had accepted $3.5 million in payments from just four drug companies in one year -- a practice that has come under increasing criticism because of concerns about conflicts of interest.
Capitol Alert: Drug company gives after Jerry Brown signs STD prevention bill
Two days after Gov. Jerry Brown signed legislation allowing children 12 and older to seek medical care for the prevention of sexually transmitted diseases without parental consent - including vaccinations against human papillomavirus, or HPV - a pharmaceutical company with a financial interest in HPV vaccines donated $8,000 to Brown's re-election campaign.
Brown's office said the contribution was not solicited, and AstraZeneca PLC said it was unrelated to Brown's action on the controversial bill.
"AstraZeneca's contributions to government officials in California are unrelated to the legislation," a spokeswoman said in an e-mail. "We provided contributions to people on both sides of the issue and did not lobby the measure."
An AstraZeneca subsidiary developed technology used in several HPV vaccines, for which the company receives royalties.
Brown spokesman Gil Duran said Brown decides legislation "on the merits of each bill." He said, "To our knowledge, no one in our office has had any contact with this company."
Brown signed Assembly Bill 499, by Assemblywoman Toni Atkins, D-San Diego, on Oct. 9, hours before a deadline to act on hundreds of bills sent by the Legislature this fall. He acted on dozens of others the same day. Brown's campaign fund received the the drug company contribution on Oct. 11, according to the Secretary of State's Office.
Brown, a Democrat, has done little fundraising since taking office in January, collecting about $45,000 in the first half of the year. He has not said if he will seek re-election in 2014.
Editor's Note: This post was updated to remove reference to AstraZeneca being based in Britain.The company entity that made the contribution is based in Delaware. Updated 6:07 p.m., Oct. 24, 2011.
New EU rules on prescription-only medicines information
The European Commission has unveiled new proposals for European Union (EU) rules to tell pharma manufacturers what information they can and cannot provide about their prescription-only medicines.In its latest reforms, to be discussed by the European Parliament and EU Council of Ministers, the Commission has limited the information that can be provided to clear functional instructions, notably labelling; package leaflets; information on prices; data on pre-clinical tests and clinical trials; and instructions for correct use. And importantly, it says this information can only be provided by in-house printed material and officially registered websites.
Under the proposals, the information ‘must be objective and unbiased; evidence-based; up-to-date; reliable; and factually correct’.
In addition it ‘should not be misleading; understandable and clearly understood; and meet the needs and expectations of patients’.
FTC to Super Committee: Ban Pay-for-Delay Deals
WASHINGTON -- The Federal Trade Commission (FTC) is calling on the Congressional super committee to ban "pay-for-delay" deals between brand-name and generic drug companies as a way to bring down the federal deficit.
"Collusive deals to keep generics off the market are already costing consumers and taxpayers $3.5 billion a year in higher drug prices," said FTC Chairman Jon Leibowitz in a press release issued Tuesday. "The increasing number of these deals is a win-win proposition for the pharmaceutical industry, but a lose-lose for everyone else."
FDA ties newer birth-control drugs to blood clots | Seattle Times
WASHINGTON — Safety concerns about the popular birth-control pill Yaz increased Thursday as federal health scientists reported that the Bayer drug and other newer birth-control treatments appear to increase the risk of dangerous blood clots more than older medications.
A new study released by the Food and Drug Administration (FDA) reviewed the medical history of more than 800,000 U.S. women taking different forms of birth control between 2001 and 2007. On average, women taking Yaz had a 75 percent greater chance of experiencing a blood clot than women taking older birth-control drugs.
Yaz contains estrogen along with a next-generation synthetic hormone called drospirenone, which is known to increase potassium in the blood. The FDA compared medical records of women taking the drug with those taking the older drug levonorgestrel.
Yaz, Yasmin and related drospirenone-containing pills were Bayer's second-best-selling franchise last year at $1.6 billion in global sales.
In 2009, the FDA took the unusual step of ordering Bayer to run corrective TV advertisements on Yaz, saying the drugmaker's marketing campaign overstated the drugs' ability to prevent acne and premenstrual syndrome.
Thursday, October 27, 2011
AstraZeneca - Seroquel What's new?
As previously disclosed, disputes continue with other insurers about the availability of coverage under other insurance policies for legal defence costs and settlements. These policies have aggregate coverage limits of $300m. On 5 September 2011 AstraZeneca Insurance Company Limited commenced formal legal proceedings in the High Court in London against certain of these insurers for recovery of money which AstraZeneca believes is due under certain of these policies which have aggregate coverage limits of $200m.
Source
Decision delayed on AZ diabetes drug | Delaware Inc.
Federal drug regulators have pushed off a decision by three months on dapagliflozin, a diabetes drug that AstraZeneca is co-developing with Bristol-Myers Squibb. That’s according to a company announcement today. A regulatory decision had been expected by Friday.
Both companies said today that regulators at the U.S. Food and Drug Administration have requested more information on the experimental drug. This comes after an FDA staff review in July highlighted concerns that dapagliflozin could increase risks of bladder and breast cancer. In trials, nine patients reported bladder cancer, compared to only one on placebo. The numbers were the same for breast cancer. An advisory panel to the FDA voted 9-6 on July 19, recommending against approval.
Dapagliflozin is a once-daily pill designed to eliminate blood sugar through urine. Analysts surveyed by Bloomberg News expected the drug to generate $144 million for AstraZeneca in 2015.
Wednesday, October 26, 2011
Doctors pharma list: Doctors list reveals who's getting big pharma money - OrlandoSentinel.com
Doctors in Florida have received more than $56 million from a dozen pharmaceutical companies since 2009, according to data released Wednesday by ProPublica, a nonprofit investigative news organization.Among those who were paid the most in Central Florida's five counties are Dr. Craig Curtis, an Orlando researcher who received $918,938 from three drug companies; Jane Hertz, a registered nurse in The Villages who was paid $111,295 by Eli Lilly; and Dr. Damon Tanton, an endocrinologist at Florida Hospital Celebration Health who earned $67,509 from Lilly.
Venture Capitalists Join Push to Ease F.D.A. Rules for Medical Device Industry
As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.
“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”
Novartis unit Alcon faces U.S. health fraud probe | Reuters
) recently acquired eyecare business Alcon is facing a U.S. government investigation into alleged healthcare fraud, the Swiss drugmaker said on Tuesday.(Reuters) - Novartis's (NOVN.VX
Alcon received a subpoena from the U.S. Department of Health and Human Services on September 23 requesting the production of documents relating to marketing practices, as well as the remuneration of healthcare providers.
The case involves the Alcon products Vigamox, Nevanac, Omnipred and Econopred, as well as surgical equipment.
Novartis revealed the case in a footnote to its third-quarter results and said Alcon was cooperating with the civil investigation.
(Reporting by Ben Hirschler. Editing by Jane Merriman)
Tuesday, October 25, 2011
BBC News - MPs condemn poor value from hi-tech equipment in NHS
The MPs also highlight big variations in how effectively the equipment is used. They say the average number of scans per CT machine varies from about 7,800 to almost 22,000 per year.
The chair of the PAC, Margaret Hodge MP, said its members were "shocked" by the unacceptable response times for certain conditions.
"A modern NHS should not allow 50% of people who have a stroke to wait more than 24 hours for a scan," she said.
Swiss Drug Giant Offers To Pay Hospitals When Cancer Drug Fails - Worldcrunch -
In an innovative "Pay for Performance" contract, the Swiss-based pharmaceutical company is presently making hospitals in Germany the following offer: they would be reimbursed for Roche’s Bevacizumab cancer medication (trade name Avastin) if it failed to halt the progress of a cancer. The offer is valid for first treatment of advanced tumors of the intestine, breast, lung or kidneys. Per month, the cost of treating a cancer patient with Avastin in Germany amounts to around 3,300 euros.
"It’s a real scandal," says Wolfgang Becker-Brüser of the Arznei-Telegramm, an independent clearinghouse for medication information for doctors and pharmacists. The current issue of the Telegramm features the story. "This is an invitation to treat with Bevacizumab patients whose chances of being helped by the drug are very slim." It could even mean that more effective treatments were withheld from patients.
"We stand by the contract," said Roche spokesman Hans-Ulrich Jelitto, adding that it also represented a contribution to lowering costs in the health sector.
Novartis to cut 2,000 manufacturing jobs | InPharm
Novartis will cut around 2,000 jobs is the US and Switzerland as part of additional cost saving measures.
The positions will go over the next three to five years and will see the closure of three manufacturing plants in Italy and Switzerland, which focus on OTC and chemicals.
The Swiss firm also said it would restructure the development organisation in Switzerland and the US that will mean relocating some research activities from Switzerland to the US.
Novartis said that it would take a fourth-quarter charge of about $300 million related to the restructuring.
Neglect of ABPI Code principles "a worrying trend"
Neglect of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice's principles covering industry communications with patients is an "emerging trend" - and this is a big problem, a leading expert has warned.
"People believe that these principles have changed because the media environment has changed - but they haven't," Rina Newton, managing director of compliance consultancy Complimed told a recent meeting of the Pharmaceutical Marketing Society (PMS) in London.
She reminded delegates that the ABPI Code requires that industry communications with patients: - must be non-promotional; - prescription-only medicines must not be advertised to the public; - be factual; - be balanced; - should not mislead regarding safety; - statements must not be made for the purpose of encouraging members of the public to ask their doctors to prescribe a specific medicine; and - not be personal.
Leaked TPPA Texts Reveal U.S. Undermining Access To Medicine | Scoop News
“New leaked texts proposed by the United States to the Trans-Pacific Free Trade Agreement show that the Obama administration has again increased demands on developing countries to trade away access to medicines. The new leaked proposals on intellectual property roll back even modest Bush era commitments to safeguard public health in trade pacts.”
— Peter Maybarduk, Public Citizen [see full analysis]“The leaked text confirms the worst fears of health officials. The Obama White House is walking back the core concessions on patent extensions, patent linkage and test data protection that were negotiated with the Bush White House in May 2007. Obama is now objectively much worse than Bush on these issues. It may help the White House raise campaign money from big drug companies, or help USTR officials find their next high paying job working as lobbyists for the drug companies. It is a huge disappointment for us. The texts cover complex issues, and it is hard to summarize all that is important. Even as regards to the reference to the WTO Doha Agreement, the White House tries to sneak in text that makes it appear as though it is limited to only some diseases or emergencies. Collectively, the provisions are designed to strengthen IPR monopolies on drugs, and make it harder to regulate prices. The consequences of stronger monopolies and higher prices are less access to medicine.”
— James Love, Knowledge Ecology International“All countries negotiating the Trans Pacific Partnership agreement should reject the US proposal regulating pharmaceutical reimbursement programs. This is an extreme proposal that has no place in a trade negotiation, particularly one with some of the poorest countries in the world.”
— Prof. Sean Flynn, Program on Information Justice and Intellectual Property, American University Washington College of Law [see full analysis]“Despite the apparent focus on procedures, the [regulatory coherence] proposal also has substantive biases in favour of light-handed regulation — a model that has proved highly problematic in many countries and sectors, not the least the financial industry.”
— Prof. Jane Kelsey, School of Law, University of Auckland [see full analysis]“The leaked draft intellectual property proposals by the United States for the Trans-Pacific Free Trade Agreement have confirmed our fears that the Obama administration is walking away from previous efforts to ensure that developing countries can access affordable medicines, setting a dangerous new standard that will likely be replicated in future trade agreements with developing nations. The administration is touting a so-called ‘access window’ as a mechanism to boost access to medicines. In fact, the administration is confusing access with affordability. The ‘access window’ is all about getting brand-name drugs to market faster, and giving their producers longer monopoly rights that prevent price-lowering competition and keeping medicines out of the hands of the millions of people who need them. Our doctors who work across the developing world rely on affordable generic medicines to trade patients. For example, competition among generic manufacturers is what brought down drug prices for HIV/AIDS by 99 percent, from US$10,000 per person per year to roughly $100 today. Trade agreements of the type being pushed this week in Peru threaten these types of crucial gains in access to life-saving medicines.”
— Judit Rius Sanjuan, Medecins Sans Frontieres/Doctors Without Borders [see full analysis]
Amgen to Pay $780 Million to Settle Marketing Accusations - NYTimes.com
Amgen said Monday that it had set aside $780 million to settle various federal and state investigations and whistle-blower lawsuits accusing it of illegal sales and marketing tactics.
Amgen said it had reached an agreement in principle to settle criminal and civil investigations that had been under way for several years by the United States attorney offices in Brooklyn and Seattle.
The company said a settlement, which it expected to be concluded in three to four months, would also resolve state Medicaid investigations and 10 whistle-blower lawsuits. It is not clear if the company will plead guilty to any criminal charges.
Most of the whistle-blower lawsuits remain under seal, but Amgen has said in regulatory filings that the lawsuits “allege that Amgen engaged in a wide variety of illegal marketing practices.”
The federal investigations, according to Amgen, seem to involve marketing, pricing and dosing of its anemia drugs, Aranesp and Epogen, and its dissemination of information about clinical trials on the safety and efficacy of those drugs. Numerous current and former executives have received civil and grand jury subpoenas, the company has said.
One whistle-blower lawsuit that was unsealed accuses the company of overfilling vials of Aranesp, essentially providing doctors with free amounts of the drug to give patients and then charge to Medicare, Medicaid or private insurers.
The lawsuit said that Amgen tried to persuade doctors to use Aranesp, rather than Procrit, a rival drug sold by Johnson & Johnson, by pointing to the extra profits the doctors could make by using the overfill and billing for it.
The lawsuit was filed by Kassie Westmoreland, a former Amgen sales representative and Aranesp product manager. The federal government declined to join the lawsuit, but more than a dozen states did join, including New York and California. Ms. Westmoreland would be entitled to part of any settlement under whistle-blower statutes.
In the past, Amgen has said the accusations were without merit.
During depositions in the case, five former Amgen executives invoked the Fifth Amendment against self-incrimination, according to court documents.
That case was scheduled to go to trial in the United States District Court in Boston on Oct. 17, but the trial was then called off, apparently because a settlement was near.
“We are very encouraged by the agreement in principle and will comment further at the appropriate time,” lawyers for Ms. Westmoreland said.
Amgen, the world’s largest biotechnology company, revealed the agreement in its earnings announcement for the third quarter. It said the charge for the settlement reduced its third-quarter earnings by 77 cents a share after taxes.
The settlement and the charge did not seem to interest investors. In the company’s conference call on Monday, no analyst asked a question about it.
Excluding the legal charge and some other special items, Amgen reported that earnings for the quarter increased 3 percent, to $1.40 a share, compared with the third quarter of 2010. Revenue also increased 3 percent, to $3.94 billion.
The company slightly raised its guidance for both revenue and earnings for 2011 as a whole. And it said it would increase its buyback of shares.
Sales of most Amgen products rose in the quarter. But sales of its anemia drugs, Aranesp and Epogen, continued to fall, in part because the Food and Drug Administration issued new safety warnings about the drugs in June. Over the last few years, studies have shown that high doses of the drugs can raise the risk of heart attacks and other problems.
Sales of Aranesp fell 4 percent in the quarter to $600 million. Sales of Epogen, which is used only by dialysis clinics, fell 27 percent, to $476 million. Medicare has changed the way it pays for dialysis to remove what had been a profit incentive for dialysis clinics to overuse Epogen.
Monday, October 24, 2011
Doctors didn't disclose spine product cancer risk in journal - JSOnline.mobi
Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company's spine surgery product in a 2009 paper about results of a large clinical trial.
The surgeons left out important data and claimed there was no significant link between the product and cancer.
The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.
The breach is the latest conflict-of-interest controversy facing Medtronic, which is under investigation by a U.S. Senate committee and the U.S. Justice Department for its marketing of the spine surgery product known as bone morphogenetic protein-2, or BMP-2.
The product is the bone growth stimulating biological agent used in the company's Infuse, which has been approved by the U.S. Food and Drug Administration, and Amplify, the unapproved product that was the subject of the 2009 paper.
In June, independent researchers found a systematic failure to report serious complications with BMP-2 in 13 papers published over nearly a decade. The papers were written by doctors who received millions of dollars from Medtronic. The unprecedented rebuke, which was published in the Spine Journal, was prompted in part by stories in the Journal Sentinel.
Medtronic and the lead author of the Amplify paper say there was no "statistically significant" cancer connection to the product at the time the paper was accepted for publication in the Journal of Bone & Joint Surgery . Medtronic also said results from the Amplify clinical trial can't be applied to BMP-2 in general.
The researchers had information showing that at two and three years after being implanted with the genetically engineered protein, significantly higher numbers of Amplify patients were being diagnosed with cancer, but they did not report it on their paper.
The authors mentioned the cancer link only in a table accompanying the paper. The text itself never addressed the concern of whether BMP-2 might fuel cancer.
"As a physician, you go by what your colleagues publish," said Charles Rosen, an orthopedic surgeon and president of the Association for Medical Ethics. "It's an abuse of trust."
Three common mistakes in medical journalism – Boing Boing
Three common mistakes in medical journalism
By Maggie Koerth-Baker at 9:49 am Monday, Oct 24
I love Gary Schwitzer, a former journalism professor at the University of Minnesota and a key advocate for better health and medical reporting at HealthNewsReview.org. Schwitzer has a quick list of the most common mistakes reporters make when writing about medical science, and I think it's something that everybody should take a look at.
Why does this bit of journalism inside-baseball matter to you? Simple. If you know how journalists are most likely to screw up, you'll be less likely to be led astray by those mistakes. And that matters a lot, especially when it comes to health science, where people are likely to make important decisions based partly on what they read in the media.
Absolute versus relative risk/benefit data
Many stories use relative risk reduction or benefit estimates without providing the absolute data. So, in other words, a drug is said to reduce the risk of hip fracture by 50% (relative risk reduction), without ever explaining that it’s a reduction from 2 fractures in 100 untreated women down to 1 fracture in 100 treated women. Yes, that’s 50%, but in order to understand the true scope of the potential benefit, people need to know that it’s only a 1% absolute risk reduction (and that all the other 99 who didn’t benefit still had to pay and still ran the risk of side effects).Association does not equal causation
A second key observation is that journalists often fail to explain the inherent limitations in observational studies – especially that they can not establish cause and effect. They can point to a strong statistical association but they can’t prove that A causes B, or that if you do A you’ll be protected from B. But over and over we see news stories suggesting causal links. They use active verbs in inaccurately suggesting established benefits.How we discuss screening tests
The third recurring problem I see in health news stories involves screening tests. ... “Screening,” I believe, should only be used to refer to looking for problems in people who don’t have signs or symptoms or a family history. So it’s like going into Yankee Stadium filled with 50,000 people about whom you know very little and looking for disease in all of them. ... I have heard women with breast cancer argue, for example, that mammograms saved their lives because they were found to have cancer just as their mothers did. I think that using “screening” in this context distorts the discussion because such a woman was obviously at higher risk because of her family history. She’s not just one of the 50,000 in the general population in the stadium. There were special reasons to look more closely in her. There may not be reasons to look more closely in the 49,999 others.Via The Knight Science Journalism Tracker
Tags: DIY, health, Journalism, medicine, mistakes, Science, skepticism
Maggie Koerth-Baker
I do the Twitter, the Google+, and (to a much lesser extent) the Facebook.
Upcoming Appearances
• October 19, 2011 in Washington, DC: Speaking at "What will turn us on in 2030?", a conference on energy futures.
• March 29-31, 2012 at York College of Pennsylvania: Writer in residence
Where not otherwise specified, this work is licensed under a Creative Commons License permitting non-commercial sharing with attribution. Boing Boing is a trademark of Happy Mutants LLC in the United States and other countries.
Details of US Attack on NZ Pharmac in Free Trade Talks | Scoop News
New Leaked Texts Reveal Details of US Attack on Pharmac in Free Trade Talks
The leaking of three further secret texts from the Trans-Pacific Partnership Agreement (TPPA) negotiations confirms fears that the US is pushing for rules on healthcare products that would give its pharmaceutical giants new tools to attack national drug buying agencies like Pharmac, Jane Kelsey said today.
The US proposed texts along with critique of their public health implications were posted on the Citizen Trade Campaign website today.
Speaking from Lima where the texts are being negotiated, Washington-based legal expert Professor Sean Flynn describes the proposed Annex on “transparency” that targets drug pricing and reimbursement programmes as “an extreme proposal that regulates public health policy and has no place in a trade negotiation”.
“This proposal is contrary to the demands of democracy, is bad for the development interests of poorer countries, and represents an affront to the best practices in evidence-based health policy, including such practices in the US”.
According to Professor Flynn, the real effect of the US proposal is to advance the pharmaceutical industry’s ultimate goals of a binding international agreement on drug pricing.
“If such an agreement is desired by countries, it should be negotiated in an open forum where public health experts and advocates are well represented, eg. the World Health Organisation.”
The leaked text on transparency strikes at the core of Pharmac, which uses its purchasing power to negotiate affordable prices for medicines.
University of Auckland Law Professor Jane Kelsey describes the combined effect of the three leaked texts as “giving Big PhRMA a platform to wage a war of harassment against Pharmac”.
“The US proposals would allow drug companies to challenge every Pharmac decision as not appropriately recognising the ‘value’ of patents – a dangerous and undefined standard. Adopting this standard would open floodgates of litigation against Pharmac and will ultimately raise medicine prices and ration access.”
“These leaked documents are being discussed at this week’s negotiating round in Lima. Yet again, we see the dangers of secret negotiations that give foreign corporations enormous leverage over our democratic processes and threaten the viability of our health care system”.
Transparency Chapter: Annex on Transparency and Procedural Fairness for Healthcare Technologies, 22 June 2011; US Textual Proposal for the TBT Chapter: Annex on Medical Devices, Pharmaceutical Products and Cosmetic Products; TPP Intellectual Property Rights Chapter (Selected Provisions), September 2011, and analyses can be accessed at http://www.citizenstrade.org/ctc/blog/2011/10/22/leaked-trans-pacific-fta-texts-reveal-u-s-undermining-access-to-medicine/
Drug firm GSK fined US$2.6 million for collusion - Channel NewsAsia
South Korea's anti-trust agency has fined drugmaker GlaxoSmithKline three billion won ($2.6 million) for conspiring with a Seoul rival over the sale of drugs, an official said Monday.The Fair Trade Commission (FTC) said GSK in 2000 offered Dong-A Pharmaceutical the exclusive right to sell its anti-nausea drug Zofran and an anti-viral medication called Valtrex.
In return, the FTC said the British-based multinational demanded that Dong-A stop selling a cheaper generic version of Zofran which the Seoul firm had introduced in 1998.
GSK also asked that Dong-A never produce or sell any drugs that could compete against Zofran and Valtrex, Kim Jun-Ha, a FTC official involved in the case, told AFP.
"With the cheaper generics made by Dong-A taken off the market, the financial burden on patients and on the government's health insurance budget has increased," Kim said.
The FTC said in a statement it estimated GSK had made wrongful gains of about 16 billion won. It said "the two firms shared benefits that were to go to consumers".
Dong-A was fined 2.1 billion won for the collusion, the agency added.
Student "Pool Party" Protests Merck | News | The Harvard Crimson
A group of Harvard global health activists staged a protest Friday in front of Merck’s laboratory near the Harvard Medical School to urge the drug company to provide discounted HIV and AIDS medicine to poor countries.
The protest was billed as a “pool party demonstration”—replete with beach balls, an inflatable pool, and students in swim trunks—to demand that Merck “jump into the pool,” a reference to the Medicine Patent Pool.
Sunday, October 23, 2011
Pfizer considers shedding two units - FT.com
Pfizer, the US pharmaceutical group, said it is examining shedding its animal health and nutrition units as part of its efforts to streamline its activities, while retaining its generics business.
The move comes after the company earlier this year said it was reviewing its mix of businesses, at a time of investor criticism over poor returns.
Still No Compensation for Trovan Victims as Pfizer Cuts Corners, Articles | THISDAY LIVE
Fifteen years after the disastrous Pfizer Trovan test trail and after an out-of-court settlement reached last year, in which the US pharmaceutical firm agreed to pay $35 million as compensation, families of the 200 victims in Kano still have no respite. With only eight of the victims’ families compensated so far, controversy is currently trailing the disbursement of the fund set up for that purpose. Olaolu Olusina investigates how the Trovan Trust Fund was usurped by those who have no bearing with the saga, thus leaving the real victims in the dark as third parties smile to the banks, in what observers describe as a national disgrace
Alhaji Mustapha Mai Sikeli is currently, not a happy man. As chairman of the Trovan Victims Forum (TVF), the umbrella body of families and next-of-kin of victims of the 1996 Pfizer Trovan trial test which killed about 200 children in Kano, Mai Sikeli is disillusioned with both the American pharmaceutical giant, Pfizer, and the Healthcare Meningitis Trust Fund, the body established by the Kano State Government to administer the compensation after the out-of-court settlement was reached with Pfizer.
His bitterness is understandable. While third parties who suffered nothing from the Trovan test saga are feeding fat on the out-of-court settlement reached with Pfizer, families of the victims are still groping in the dark, 15 years after. With a whopping $30 million already released to the Kano State Government and another $10 million gone to the lawyers representing the state government in the case instituted against Pfizer, the disbursement of the $35 million meant for the families of the victims is surrounded by controversy, as the victims and their lawyers appear to have been sidelined in the out-of-court settlement brokered by the government with Pfizer on the matter. Delays in settling the families of the victims, THISDAY learnt, arose from Pfizer’s insistence on DNA testing to ensure that the right people are compensated.Origins of the Saga
A deadly meningitis epidemic had ravaged Nigeria in 1996. Described as the worst in the history of the country, the epidemic had claimed about 12,000 lives over a six-month period. The northern part of the country was mostly affected and health services were strained. Pfizer, under the guise of rendering humanitarian assistance in view of the epidemic, had joined other international relief agencies such as the Red Cross and Doctors Without Borders.
It however used the opportunity to conduct a clinical test of its newly-developed anti-meningitis drug, Trovan, on children in Kano, and this proved fatal, resulting in the death of 100 of them and causing varying degrees of injuries and deformities in 100 others. The most worrisome aspect was that Pfizer even got an import duty waiver for the drug, just as the approval letter for the test was allegedly forged by an official of the Kano State Ministry of Health.
To boot, an American doctor working with Pfizer, Dr. Juan Walterspiel, who was aware of the unethical conduct of the pharmaceutical firm and exposed its antics, was fired by Pfizer.Legal Fireworks
Though Pfizer denied that the deaths were as a result of the clinical test of its new drug, families of the victims dragged the pharmaceutical firm to court in the United States of America with legal suits initiated in New York and Connecticut. Despite the initial challenges of the legal battle, the New York Division of the US Court of Appeal, in what had become a landmark judgment in January 2009, ruled that Pfizer could be sued in the US.
In spite of the fact that cases had been pending since 2001 and 2002, THISDAY gathered that the Kano State Government and the federal government, acting on the advice of some smart lawyers bent on making money out of the situation, decided to slam a criminal case against Pfizer. And in a rare display of government strength, Kano sued for $2 billion while the federal government sued for $6 billion in Nigeria. This, it was learnt, was done at a time the victims already had cases pending against Pfizer in the US with the victims represented by their lawyers.Mediation and Settlement
Against the threat of being stopped from doing business in Nigeria, Pfizer was left with no option than to settle out of court. It therefore engaged the services of former military Head of State, General Yakubu Gowon, to mediate on its behalf in order to broker a deal with the government. But the deal that was brokered by Gowon after several meetings in London and Dubai disappointingly put the value of every Nigerian child killed or deformed by the tests at $175,000. At the end of negotiations, Pfizer settled for a $75 million compensation deal.
Leading the Kano government delegation was former state attorney general, Barrister Aliyu Umar, while the federal government was represented by former attorney general, Mr. Michael Aondoakaa, as leader of its team. In the final settlement, Pfizer agreed to pay $35 million as compensation to the families of the 200 children, with each family receiving $175,000. It also agreed to pay $30 million to the Kano State Government towards the construction of a health facility, while another $10 million was to be paid to the legal team representing Kano state for their services. THISDAY further learnt that a secret settlement deal was also reached between Pfizer and the federal government for an undisclosed amount.Trust Fund
In January 2009, a Healthcare Meningitis Trust Fund was jointly established by Pfizer and the Kano State Government to manage the disbursement of the compensation. Chaired by Justice Abubakar Bashir Wali, the board of the Trust Fund is made up of three appointees of the state government and another three appointed by Pfizer, with Pfizer allegedly paying all the bills of the fund.
With a modest office complex as its secretariat in Kano, THISDAY reliably gathered that each member of the board of the Trust Fund receives a whopping N400,000 as sitting allowances while those who suffered from the test are dying gradually. In the same vein, the government lawyers have received their fees and smiling all the way to the bank while construction work on the state-of-the-art paedriatric medical facility in Kano is nearing completion.The Medical Centre
Immediate past governor of the state, Mallam Ibrahim Shekarau, late last year performed the foundation laying ceremony of the medical centre that has the potential of becoming the largest paediatric centre in West Africa.
At the foundation laying ceremony in Kano, chairman of the Kano/Pfizer Healthcare Programs Trust Board, Professor Shehu Galadanci, put the cost of the medical facility at N 3.825 billion. He explained that the 200-bed facility will also have a fully equipped microbiology laboratory for the research and management of contagious conditions that often result in serious outbreak of cholera and meningitis. He said, when completed, the medical centre will have a state-of-the-art diagnostic equipment for the diagnosis and treatment of many conditions, including cancer and serious life threatening infectious diseases that are presently treated only overseas.
The chairman stressed that the people of Kano will now have the benefit of access to modern treatment facilities within their reach of the people and noted that the contracts were awarded after a thorough tender process that is in line with international standards, adding that the project will be completed in August 2011. When THISDAY visited the centre at Kwanar Dawaki, work on the project site situated at Dawakin Kudu was in progress and construction of some of the structures was nearing completion.Side Distractions
But there are fears that the project may suffer a setback going by the utterances of the state governor, Alhaji Rabiu Musa Kwankwaso, who faulted the choice of the site of the project that was originally meant to serve as an international cattle market. Kwankwaso has said although the hospital project initiated by Pfizer as part of compensation for the controversial Trovan test is a good one, it was “politically situated” at Kwanar Dawaki, which is on the outskirts of Kano city. “The selection of the site was very political; the site was for our cattle market. One cannot not understand why the hospital was sited there. It is a very good project in a very wrong place,” he had stressed.
He had pointed out that he had promised during his campaign tour that the market must stand because of the investment made in the project during his first tenure between 1999 and 2003. While promising to visit the site to see the level of execution of the hospital project after which a decision would be reached on where to relocate the cattle market, he said he will give it prompt attention, adding, “We don’t want issues like this to be left hanging, so we would resolve this.”
On compensation to the Trovan test victims, the governor advised that action be expedited in paying them, pointing out that they ought to have received compensation first before other claimants were settled from the monies paid by Pfizer. The governor, who regretted that the Pfizer tests were a sad development in the history of the state, said he was pleased that “the action taken by all concerned was positive now that Pfizer has to pay huge sums to the victims as compensation.”Breach of Agreement
But despite the huge amount pledged by Pfizer as compensation, the victims of the clinical trial whose predicament led to the court cases still languish in penury with some of them dying one after the other. Mai Sikeli’s association, TVF, represents 192 out of the 200 test victims of the 1996 clinical test. So far, no member of his association has been paid any compensation as they wait endlessly for the results of the DNA tests.
Out of frustration, they made a move last March through their lawyers to stop the Trust Fund and Pfizer from going ahead with the DNA tests, saying the entire exercise was shrouded in secrecy and could no longer be trusted. Their grouse was that the DNA tests being conducted consequent upon which compensation would be paid were taking too long. They also alleged that Pfizer had breached most of the agreements reached with the victims.
THISDAY gathered that whereas the world is being told that Pfizer is paying $175,000 per victim, only four people had been paid $175,000 each while others received between $10,000 and $80,000. In a letter dated May 15 2010 from A.A. Mu’Allimu & Co., counsel to the Trust Fund, a copy of which was obtained by THISDAY, the fund solicited the cooperation and patience of the TVF and its lawyers in the process that was adopted for the compensations, especially the DNA tests. The letter signed by Mr. Auwal Abubakar Muallimu also called for understanding in the payment formula for victims who suffered injuries or deformity as they were to receive between $10,000 and $80,000 instead of the $175,000 per victim, whether living or dead, by Pfizer.
But in a petition to the pharmaceutical company, a copy of which was obtained by THISDAY in Kano, Mai Sikeli alleged that Pfizer had breached most of the agreements reached with the victims and demanded to know the rationale behind the delay in releasing the results of the DNA samples of members of his group which were taken in March 2011, as they were told results would be out after six months.
“Neither Pfizer nor the Pfizer Meningitis Trust has said anything about the exercise since then, which suggests that a hidden agenda between the two parties is unfolding in the compensation process,” he alleged. The TVF chairman also wondered why both Pfizer and the Trust Fund were only emphasising the DNA tests, ignoring other vital data such as the claimant’s initials, date of birth, gender and photographs of the victims in the compensation process.
According to TVF members, Pfizer had in the past claimed to have extracted fluid samples from each Trovan participant from where the DNA records could be obtained, but alleged that the drug company took away the fluid samples to its headquarters in the US.
They are therefore querying if Pfizer complied with the provisions of the Nigerian Customs and Excise Act at the time of exporting the fluids and if it had also complied with the provisions of the Food and Drug Administration of the United States before importing and preserving the fluids in the US for a very long time.
They also have expressed reservations in the manner the Trust Fund was trying to hand pick six victims out of the 192 members of association for compensation without processing their DNA test results. “If the board of the Trust Fund argued that the six victims were considered based on documentary evidence, how did they arrive at clearing them without possessing 192 DNA results from Pfizer,” they queried.
They also want to know why Pfizer was so willing to spend several millions of dollars on various aspects of the 1992 Trovan drug saga and remained reluctant to use a fraction of the money to settle its victims. They are also asking why various third parties are benefitting from the compensation process at the expense of the real victims.
“The whole arrangement is fraudulent. The victims themselves who were used as guinea pigs are being paid less than the $175,000 each as stipulated in the agreement. Pfizer is cutting corners and saving money as the shortfall in payment goes back to them. The compensation ratio is not equitable,” a lawyer conversant with the case told this reporter.
The lawyer, who craved anonymity, also doubted whether there was any DNA kept anywhere. “If you have DNA results, how do we know it’s not been tampered with or has not been swapped? Pfizer chose the laboratory and said it was in possession of the samples. What is holding the company from releasing the results and how are we sure that the samples have not been tampered with. This is all fraud. Where was the Federal Ministry of Health in all this? Nobody is asking any questions since money has changed hands. Kano government itself had sold out its citizens for a plate of porridge. The case is a national disgrace,” this reporter was told.Alleged Blackmail
But in a new twist to the saga, a civil society group, Proletarian Agenda, recently slammed the TVF, accusing it of blackmail over reports that the victims may be heading back to court. National Coordinator of the Proletariat Agenda, Mallam Umar Sani, in a statement, noted that TVF’s cases had been settled out of court before their members agreed to subject themselves to DNA tests, stating, “Indeed, the TVF was responsible for the delays in the DNA process because the body obtained a court injunction to stop it.”
Sani also accused the 192 members of the TVF of receiving $5,000 each before they agreed to withdraw their cases from court. “Now, with the rumour that only six out of the 192 TVF members were DNA-matched with actual participants in the Trovan study, the other pretenders and impostors are being egged on by their greedy sponsors to muddy the waters all over again by casting aspersions on the scientific DNA process and are threatening to go back to court,” he said.TVF’s Defence
TVF chairman, Mai Sikeli, declined to comment on the issues raised when this reporter contacted him, saying he would only comment with the permission of his association’s lawyers. However speaking with THISDAY on the charges made by the Proletarian Agenda, a member of the TVF who craved anonymity, said it was true that the members were paid the $5,000, maintaining that it was part of the agreement for withdrawing the initial suit and was supposed to be payment to ‘alleviate suffering’ after their perseverance over the last 15 years.
“It was not a secret payment as is being insinuated and is not part of the compensation of $175,000. Without any form of assistance for 15 years while others were feeding fat on our predicament, we trudged along. So the money was supposed to provide us some relief,” THISDAY was informed.
In a statement after the first payments were made to families of four victims in August, Pfizer had stated, “This is the first step in a multi-phase review process by which the independent board of trustees that manages the fund will deliver payment to all other qualified claimants. We thank them for their commitment and dedication to seeing this process through in the most timely and transparent way possible.”
Chairman of the Trust Fund, Justice Wali, could not be reached at the time of filing this report as his phone was switched off. Kano State Commissioner for Information, Professor Umar Farouk, also declined comment when contacted by THISDAY. So also did the spokesman of former governor of the state, Alhaji Sule Yau Sule, who said he could not say anything as he was out of the country.
But former Kano State attorney general, Umar, who led the Kano government delegation to sign the agreement with Pfizer told THISDAY that though he participated in signing the agreement, there was no way he could influence the work of the committee set up to implement it.
“There is an independent board set up to do the job. It is made up of three representatives of Kano State Government and three others representing Pfizer. But they are independent of both the government and Pfizer. Now, they have set up requirements to be met for compensation to be made. If any of the claimants feels aggrieved by the decisions of the board, such a claimant is free to seek arbitration,” Umar told this reporter.
Saturday, October 22, 2011
Bayer is getting out of Wayne
The global drug giant Bayer AG plans to close its Wayne facility and move the workforce there to a campus in the Whippany section of Hanover Township, beginning in 2013, the company said on Friday.
http://www.northjersey.com/news/132368328_Bayer_is_shutting_facility_in_Wayne.html