Friday, January 9, 2009

FDA Scientist Complain to Obama about FDA corruption

FDA scientists complain to Obama of 'corruption'
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer Ricardo Alonso-zaldivar, Associated Press Writer Thu Jan 8, 6:22 pm ET

WASHINGTON – In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.

FDA spokeswoman Judy Leon said in response: "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency's reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA's in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers "committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along," the letter said.

A spokeswoman said the Obama transition team had no comment.

Copyright © 2009 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten or redistributed without the prior written authority of The Associated Press.

http://news.yahoo.com/s/ap/20090108/ap_on_go_ot/fda_dissidents/print

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Saturday, January 3, 2009

The Politics of Marketing Gardasil

August 20, 2008
The Evidence Gap
Drug Makers' Push Leads to Cancer Vaccines' Rise
By ELISABETH ROSENTHAL

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West's disease of the moment.

Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.

One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion; proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall. Even the normally stingy British National Health Service will start giving the other vaccine — Cervarix, from GlaxoSmithKline — to all 12-year-old girls at school this September.

The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines, which offer some protection against infection from sexually transmitted viruses, are far more expensive than earlier vaccines against other diseases — Gardasil's list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits (and often only partially covered by health insurance).

Award-winning advertising has promoted the vaccines. Before the film "Sex and the City," some moviegoers in the United States saw ads for Gardasil. On YouTube and in advertisements on popular shows like "Law and Order," a multiethnic cast of young professionals urges girls to become "one less statistic" by getting vaccinated.

The vaccine makers have also brought attention to cervical cancer by providing money for activities by patients' and women's groups, doctors and medical experts, lobbyists and political organizations interested in the disease, sometimes in ways that skirt disclosure requirements or obscure the companies' involvement.

Even critics of the marketing efforts recognize the benefits of the vaccines. Girls who get the shots are less likely to have Pap tests with worrisome results that would lead to further treatment, saving themselves anxiety and discomfort and, in those cases, saving money. When it occurs, cervical cancer is a dreadful disease; genital warts, partly prevented by the Merck vaccine, can be a painful nuisance.

But some experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them. They say that because of the aggressive marketing, even parents of girls who are far from being sexually active may feel pressured into giving them a vaccine that is not yet needed and whose long-term impact is still unclear. Legislative efforts to require girls to have the vaccine only add to the pressure.

In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.

"There was incredible pressure from industry and politics," said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the Centers for Disease Control and Prevention that recommended the vaccine for all girls once they reached 11 or 12........Much more at the link



http://www.nytimes.com/2008/08/20/health/policy/20vaccine.html?fta=y&pagewanted=print

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Friday, January 2, 2009

Fosomax-type drugs linked to jaw necrosis

USC dentist links Fosomax-type drugs to jaw necrosis
Posted On: January 1, 2009 - 5:30pm

Researchers at the University Of Southern California, School Of Dentistry release results of clinical data that links oral bisphosphonates to increased jaw necrosis. The study is among the first to acknowledge that even short-term use of common oral osteoporosis drugs may leave the jaw vulnerable to devastating necrosis, according to the report appearing in the January 1 Journal of the American Dental Association (JADA).

Osteoporosis currently affects 10 million Americans. Fosomax is the most widely prescribed oral bisphosphonate, ranking as the 21st most prescribed drug on the market since 2006, according to a 2007 report released by IMS Health.

"Oral Bisphosphonate Use and the Prevalence of Osteonecrosis of the Jaw: An Institutional Inquiry" is the first large institutional study in the U.S. to investigate the relationship between oral bisphosphonate use and jaw bone death, said principal investigator Parish Sedghizadeh, assistant professor of clinical dentistry with the USC School of Dentistry.

After controlling for referral bias, nine of 208 healthy School of Dentistry patients who take or have taken Fosamax for any length of time were diagnosed with osteonecrosis of the jaw (ONJ). The study's results are in contrast to drug makers' prior assertions that bisphosphonate-related ONJ risk is only noticeable with intravenous use of the drugs, not oral usage, Sedghizadeh said. "We've been told that the risk with oral bisphosphonates is negligible, but four percent is not negligible," he said.

Most doctors who have prescribed bisphosphonates have not told patients about any oral health risks associated with the use of the drugs, despite even short-term usage posing a risk due to the drug's tenacious 10-year half life in bone tissue. Lydia Macwilliams of Los Angeles said no one told her about the risk posed by her three years of Fosamax usage until she became a patient of Sedghizadeh at the School of Dentistry. "I was surprised," she said. "My doctor who prescribed the Fosamax didn't tell me about any possible problems with my teeth."

Macwilliams was especially at risk for complications because she was to have three teeth extracted. The infection is a biofilm bacterial process, meaning that the bacteria infecting the mouth and jaw tissues reside within a slimy matrix that protects the bacteria from many conventional antibiotic treatments, and bisphosphonate use may make the infection more aggressive in adhering to the jaw, Sedghizadeh said. The danger is especially pronounced with procedures that directly expose the jaw bone, such as tooth extractions and other oral surgery. After her extractions, two of the three extraction sites had difficulty healing due to infection, Macwilliams said. Luckily, with treatment as well as the rigorous oral hygiene regimen USC dentists developed especially for patients with a history of bisphosphonate usage, the remaining sites slowly but fully healed. "It took about a year to heal," she said, "but it's doing just fine now."

Sedghizadeh hopes to have other researchers confirm his findings and thus encourage more doctors and dentists to talk with patients about the oral health risks associated with the widely used drugs. The results confirm the suspicions of many in the oral health field, he said. "Here at the School of Dentistry we're getting two or three new patients a week that have bisphosphonate-related ONJ," he said, "and I know we're not the only ones seeing it."

Source: University of Southern California

http://www.sciencecodex.com/usc_dentist_links_fosomaxtype_drugs_to_jaw_necrosis

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Monday, December 29, 2008

Many Older Americans Take Risky Drug Combos

Millions of older Americans use risky drug combos

from The Associated Press

CHICAGO December 24, 2008, 06:24 am ET · At least 2 million older Americans are taking a combination of drugs or supplements that can be a risky mix — from blood thinners and cholesterol pills to aspirin and ginkgo capsules — a new study warns.

Among older men, the numbers are particularly alarming — one in 10 are taking potentially harmful combinations, according to the study.

The results aren't always disastrous, but older people are more vulnerable to side effects and drug-to-drug interactions. And patients need to know that just because lots of medicines and supplements don't require prescriptions doesn't mean they're harmless. Nor are some of these safe to take when you're prescribed other medications.

Experts say the take-home advice is to ask about any side effects of prescription drugs, and tell your doctor before taking other medicines.

The report showing just how many older people are using risky combinations comes from a study of nearly 3,000 interviews with people aged 57 to 85. The research, funded by the National Institutes of Health and University of Chicago, appears in Wednesday's Journal of the American Medical Association.

It's well-known that as people age, their medication use goes up. But the study highlights the potential problems with some sobering statistics.

Ninety-one percent in this age group use at least one medication, often for heart disease and related problems. That translates to more than 50 million people. More than half use at least five remedies, including prescriptions, over-the-counter medicines or supplements.

Virtually every medicine can have side effects, and with so many being used by so many older adults, the potential for harm is high.

For example, warfarin, a potent prescription clot-fighting drug, was often taken with aspirin. Both increase the risk of bleeding, so the odds are even higher when both drugs are taken. The researchers said these risks also occur when warfarin is taken with garlic pills, which some studies have suggested can benefit the heart and help prevent blood clots.

Signs of bleeding problems include bruising easily, hard-to-stop bleeding from the gums or from cuts and blood in the urine.

Other commonly used and risky combinations included:

—Aspirin taken with over-the-counter ginkgo supplements, increasing chances for excess bleeding.

—Lisinopril, a blood pressure drug, taken with potassium, which combined can cause abnormal heart rhythms. Potassium is often prescribed to restore low levels of this important mineral caused by certain blood pressure drugs.

—Prescription cholesterol drugs called statins taken with over-the-counter niacin, a type of vitamin B that also lowers cholesterol. This combination increases risks for muscle damage.

"Patients need to know that while medications are often beneficial, they're not always safe," said lead author Dima Qato, a University of Chicago pharmacist. "If they need to self-medicate with over-the-counter or dietary supplements, they should definitely consult with their physicians or pharmacists."

The study relied on data from in-person interviews with 2,976 adults questioned about which medications they routinely used. The nationally representative survey was done between June 2005 and March 2006, and results were extrapolated to the general population.

The researchers assessed how many people routinely used at least two medications of any type known to have dangerous or even fatal interactions. The number totaled at least one in 25, corresponding to 2.2 million nationwide.

Those interviewed weren't asked if they'd ever had a bad reaction from taking those combinations. And the study didn't assess whether patients were taking medications inappropriately.

Dr. Jerry Gurwitz, chief of the geriatric medicine division at University of Massachusetts Medical School, said taking multiple medications, despite possible bad interactions, isn't necessarily a bad idea as long as patients are in close contact with their doctor.

"There are definitely many instances where if they're monitored carefully and there's good reason for using them, that they could be used safely," said Gurwitz, who wasn't involved in the study.

Prescription drugs were the most commonly used and nearly one-third used at least five prescription drugs.

Michael Cohen, a pharmacist and president of the Institute for Safe Medication Practices, called the study an important snapshot of medication use in older Americans. But as someone who takes at least five medications himself, Cohen said the widespread prevalence isn't surprising.

Cohen said his group recently launched a new Web site, http://www.consumermedsafety.org that will allow consumers to enter names of their medications to check for any potentially dangerous interactions.

———

On the Net:

JAMA: http://jama.ama-assn.org

Institute for Safe Medication Practices: http://www.ismp.org


http://www.npr.org/templates/story/story.php?storyId=98676403

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Vaccine Charges etc.

NPR's morning edition had this interesting news article on vaccine problems which have everything to do with finances and medical policies and nothing to do with the so-called "anti-vaccination crowd."

Charges For Vaccines Vary Widely, Study Finds

by Brenda Wilson

Morning Edition, December 29, 2008 · A study published in this month's Pediatrics journal found that there was an exceedingly wide variation not only in what pediatricians and family practitioners paid for vaccines, but also in the reimbursements they received from insurers and managed care organizations.

Dr. Gary Freed of the University of Michigan Health Systems says he undertook a study of physician costs associated with childhood immunization because he kept hearing complaints from physicians that they couldn't make ends meet and were losing money on immunizations.

"It turns out," Freed says, "that some physicians were paying over three times what other physicians were for the exact same vaccine. By the same token, we found that some physicians were being reimbursed twice as much as other physicians for the same vaccine. So, some were paying too much and getting reimbursed too little."

For example, the study showed that some doctors reported buying the vaccine for chickenpox (varicella) for about $66 a dose. Other physicians paid as much as $87 for the same vaccine. Reimbursement from the most common insurers was as low as $57.

Some Physicians Unsure Of Costs

Private practices are like small business. But that's not how many physicians run them. When Freed called some physicians he says he found "some physicians that quite honestly didn't know what they were paying for vaccines and had to dig up records and make new calculations to figure that out."

As late as 2000, the study shows, the full course for the recommended schedule of childhood vaccines cost $600 per child in the private sector. Now, with more than 20 recommended childhood vaccines, the cost is up to $1,500.

Richard Lander, a pediatrician in Livingston, N.J., became aware of the costs as the number of childhood immunizations grew along with those costs. He says he stopped buying the vaccines directly from the manufacturers and started shopping around. He noticed that he would pay one price for the vaccine, and the insurer would reimburse him $1 less. He began keeping close tabs.

He says he began tracking where he bought the vaccines and whether he was able to get them at a good price or not.

"We will bill for the vaccine we've administered and we will bill for the vaccine administration fee. Many managed care organizations will say 'Why are you so interested in getting paid more for the vaccine administration fee? Look how well I pay you for the vaccine.' We're talking about a product and we're talking about a service. Don't pay me for one and not pay me for the other," he says.

Costs Add Up

Those aren't the only costs associated with childhood immunization that physicians must bear. There are the administrative costs for the time and staff to keep record of vaccinations and to order and stock the vaccines. There's the cost of refrigerators to store vaccines and the costs of electricity and insurance.

As a consequence, many physicians are in fact losing money on childhood immunizations.

"Some of these vaccines cost over $100 a dose and if you are thinking about stocking 60 to 100 doses in your practice, that is a significant outlay," he says.

It can take anywhere from 30 to 90 days for physicians to be reimbursed.

At least a fifth of family practitioners say they can no longer afford to vaccinate children, which can be a problem particularly in rural areas of the country where there are often no alternatives. Only 5 percent of pediatricians say they are considering not vaccinating, but 40 percent of them feel inadequately paid by insurers, according to the study.

The government buys about half of all vaccines that are provided free for children who are not insured. Ninety percent, however, are administered by private practitioners, and the government pays only a nominal fee — about $11 —for administering the vaccine.

Susan Pisano, a spokesperson for the health insurer advocacy group America's Health Insurance Plans, says private insurers are being asked to pick up the government's slack.

"What has happened is that because government, Medicare and Medicaid typically pays providers, doctors and hospitals less, those doctors and hospitals have been expecting greater payment from employer-sponsored plans," she says. "Most doctors and pediatricians are operating at a profit and employers and consumers should not have to pay for the inefficient ones."

Looking Ahead

To reduce his costs, Lander who chairs a committee of the American Academy of Pediatrics on managing practices, has also been working with other pediatricians to get better reimbursement rates. He started a group purchasing organization. Doctors who join can buy vaccines at a discount.

But he says he's still losing money on insurers. One insurer wanted to pay him even less than the federal government does. He dropped the company. Patients covered by the company who decided to stay with him got medical care at a discount.

Organizing would help, Freed says, but pediatricians and family practitioners are working at a disadvantage in that physicians are barred by law from sharing information about costs and reimbursements.

http://www.npr.org/templates/story/story.php?storyId=98743907

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Thursday, December 25, 2008

Mass Media Science Reporting with reference to misleading statistics about statins

Making Sense of Science Reporting

By Deborah Howell
Sunday, December 7, 2008; B06

The job of science reporters is to take complicated subjects and translate them for readers who are not scientifically sophisticated. Critics say that the news media oversimplify and aren't skeptical enough of financing by special interests.

That led me to review papers that are to be published soon as part of a project sponsored by the American Academy of Arts and Sciences on how the media cover science and technology, and to interview a half-dozen experts, from scientists to teachers of science writing. Here's my take:

· Look for the evidence. News organizations should give weight to scientific evidence, whether it is about global warming or what the medical establishment says about Lyme disease.

Post science reporter David Brown, who is also a physician, talked about this in a recent speech at the University of Iowa. It will be published next year. "In science, there is a natural tension between evidence and opinion, and evidence always wins. What authority figures have to say about anything in science is ultimately irrelevant. Unfortunately, in a lot of science reporting, as in a lot of reporting in general, that isn't the case.''(my italics)

Science reporters should give readers enough information to judge "the strength of a claim" and report "how the news fits into what's already known about the subject," Brown said. "It isn't always easy to boil down research findings to a few numbers that capture the essence" of a study. "Sometimes it can't be done or can't be done on deadline," he said. So follow-ups are important.

Brown recommends noticing how much space in an article is devoted to describing the evidence of the newsworthiness of the story and how much is devoted to someone telling you what to think about it. "If there isn't enough information to give you, the reader, a fighting chance to decide for yourself whether something is important, then somebody isn't doing his job, or hers."

· Look for context. Are the results preliminary? Does the research conflict with or confirm earlier work? Has it been published in a reputable science journal or been presented at a science meeting?

· Look beyond the lead paragraph and headline. Remember that antioxidants were touted to prevent all sorts of disease; research proved that not to be true. One recent Page 1 story, by veteran Post science reporter Rob Stein, attracted comment and criticism. Stein wrote that a study produced "powerful evidence" that a blood test designed to monitor inflammation could identify "seemingly healthy people who are at increased risk for a heart attack or stroke" and that a widely used statin drug offered "potent protection against the nation's leading killers." The story quoted the study's author and other prominent experts as calling the findings a "breakthrough," a "blockbuster" and "absolutely paradigm-shifting."

The Foundation for Integrative AIDS Research (FIAR) -- which has a stake in the issue because AIDS drugs can raise "bad" cholesterol levels -- said stories about the study reflected "shoddy boosterism for the pharmaceutical industry rather than a careful and balanced analysis."

FIAR Director George M. Carter's chief complaint was that stories emphasized a change in "relative risk" -- a 44 percent fall in the number of heart attacks, strokes and surgical procedures among people taking the statin, compared with those in the placebo group. He said the fact that everyone in the study had an extremely low "absolute risk" for heart problems should have been emphasized more. About 1.36 percent of people taking the placebo suffered a heart attack or stroke; that fell to 0.8 percent among those taking the statin. That means that nearly 97 percent of the people using the drug would not see any benefit, he said.

Stein quoted a skeptic in the ninth paragraph and noted near the story's end that "the actual risk reduction for an individual would be very small, given the relatively low risk for most middle-age people, so that the benefits easily could be outweighed by the costs of thousands more people taking tests, drugs and being monitored by doctors."

Stein said, "While I would have liked to have explored many of the nuances of this study more fully, I feel confident we struck a responsible balance. I think it's crucial to provide readers with both the evidence supporting new claims and enough context and interpretation to help them gauge its significance." Independent experts, he said, concluded the study was "a very well done, very convincing piece of research."

One of the issues in science reporting is that most readers aren't schooled in statistics. Harold Varmus, former director of the National Institutes of Health, recommends looking more deeply into the numbers. "The percentages may be high, but what is the risk of an event in the first place? If the risk is low, there's a much smaller benefit." Varmus, a Nobel laureate, is chief executive of Memorial Sloan-Kettering Cancer Center.

Marcia Angell, a physician and former editor of the New England Journal of Medicine who is now a senior lecturer at Harvard Medical School, said journalists can write "overly dramatic" stories for "gullible" readers. "Everyone has an interest in hyping news of medical research -- the researcher, the institution, reporters. Readers should be very skeptical of new findings. Newspapers are in the business of telling you the news, which needs to be startling or counterintuitive or flies in the face of what we knew. By definition these stories are less likely to be accurate."

Don J. Melnick, professor of conservation biology at Columbia University, said that if a story "doesn't sound newsworthy or front page-worthy, it will be buried or not printed at all. That tends to promote people hyping the research. They have to convince their editors to put it in the paper."

Nils Bruzelius, The Post's science editor, said, "I thought the story and Page 1 play were justified because the potential impact was significant, even as I understand the criticisms. There's an inevitable tension between the desire of reporters and editors to get good play for their stories and the need to avoid hype or overstatement, and we feel this very acutely in dealing with scientific or medical stories, because the advances, even those that prove to be part of something very big, usually come in incremental steps. I've long believed that science and medical stories enter this competition at some disadvantage. I certainly don't have data on this but I suspect that most of the top editors who make the front-page decisions tend to be less drawn to these topics than the average reader because, with a few exceptions, they are a naturally self-selected group who got to where they are by dint of their interest and ability in covering such topics as politics, international relations, war and national security -- not science."

· Who sponsored the research and who makes money from its findings? Angell, a critic of drug companies' influence on medical research, said, "The caveats are at the end [of the story]. The pharmaceutical industry is spreading money everywhere and the researchers have their hands out."

That was true of the statin story. In the last six paragraphs, readers learned that the study was financed by AstraZeneca, which makes the statin Crestor, and that the study's author and his hospital will receive royalties on the blood test that was studied. Drugmakers fund many large medical studies. The story said that the company had no influence over the analysis.

Varmus said there is no mechanism for support or motivation to conduct clinical trials without drug industry money. "Obviously, companies have a vested interest in a good outcome and being truthful and getting answers that won't cause them grief later on," he said. Such trials also must follow Food and Drug Administration regulations.

"It's not new that the industry is the primary source of funding clinical research," Angell said. "What is new is the strings attached and the willingness of medical schools and faculty to accept these strings. They have influence over every detail of clinical trials."

Jonathan Weiner, who teaches science writing at the Columbia University Graduate School of Journalism, said, "It's a very messy, complicated problem. With government funding tight, many doctors rely on industry for funding. People in research medicine can't stay current without going to industry-funded conferences that have the quality of junkets." Weiner wrote "The Beak of the Finch," a book about evolutionary biology that won the Pulitzer Prize for general nonfiction in 1995.

For readers, Brown's best advice is this: "In the end, all that counts is evidence."

A longer version of this column appears online. Deborah Howell can be reached at 202-334-7582 or at ombudsman@washpost.com.

View all comments

http://www.washingtonpost.com/wp-dyn/content/article/2008/12/05/AR2008120502959_pf.html

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Friday, December 19, 2008

Did a "big pharma" company contaminate a Nobel Prize selection?

From The Times
December 19, 2008
AstraZeneca row as corruption claims engulf Nobel prize

David Charter

The integrity of the Nobel prize was called into question last night after it emerged that a member of the jury also sat on the board of a pharmaceuticals giant that benefited from the award of this year's prize for medicine.

Prosecutors were studying whether AstraZeneca, the London-based multi-national pharmaceutical company, could have exerted undue influence on the award.

The joint winner of this year's Nobel Prize for Medicine, Harald zur Hausen, was recognised for his work on the human papilloma virus (HPV), which can lead to cervical cancer. AstraZeneca has a stake in two lucrative vaccines against the virus.

Two senior figures in the process that chose Mr zur Hausen have strong links with the pharmaceutical company, which has also recently begun sponsoring the Nobel website and pro-motional subsidiary. The company strongly denies any wrongdoing.

It is not the only question mark hanging over the probity of the Stockholm-based foundation. The Swedish prosecutor yesterday opened a parallel investigation into bribery allegations after several members of Nobel committees admitted enjoying expenses-paid trips to China to tell officials how candidates are selected for prizes.

Other members of the Nobel Foundation are said to be gravely concerned that the reputation of an organisation that honours the highest achievements in human endeavour is under threat from companies and nations hungry for Nobel glory.

Questions began to be asked about AstraZeneca's role after it agreed to sponsor Nobel Media and Nobel Web. Neither the company nor the foundation will say how much the contracts are worth, although they are estimated to run into hundreds of thousands of dollars over the next three years.

Further concerns were raised by Swedish radio, which revealed that Bertil Fredholm, the chairman of the five-strong committee that assesses Nobel candidates, was a paid consultant for AstraZeneca in 2006. Bo Angelin, a member of the 50-strong committee that votes for the winner, also sits on the board.

Last year, AstraZeneca acquired a company that developed a key component licensed for the production of two HPV vaccines made by other companies.

Christer van der Kwast, the director of the Swedish police anticorruption unit, ordered a preliminary investigation. His actions have been dismissed by Michael Sohlman, executive director of the Nobel Foundation, who told Scientific American magazine: "How should I put this? He often appears in the media."

Mr van der Kwast told The Times last night: "My initiative was to look into this to see if there were grounds for investigation. I have ordered the prosecutor-in-charge to look into this."

A spokesman for AstraZeneca rejected any suggestion that its influence over the Nobel Foundation was improper. He said: "We have no influence over the prizewinners nor would we ever seek to.AstraZeneca as a company is not involved in the process of Nobel prize selection. Bo Angelin's involvement on the Nobel committee is completely independent of his role on AstraZeneca's board. Bertil Fredholm is a well-respected expert. He did some work for us in 2006, as we work with many people who are experts in their field. The relationship was . . . no more than that.".......



http://www.timesonline.co.uk/tol/news/world/europe/article5367941.ece?print=yes&randnum=1229699021867

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