Conflict of Interest Information - Drug Companies, CDC, FDA, Doctors, $$$$


sorry if all the links don't work - url's are changing and disappearing all the time - I may have the original if you email me
Any information obtained here is not to be construed as medical or legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone.


FOLLOW THE MONEY: PART ONE An examination of the PR and financial incentives behind vaccination programs, By Hilary Butler, October 2003
EMAIL me if you are not able to access this file vaccineinfo@tesco.net

Revolving door between the US Government and Industry

Congressman Burton critical of Vaccine Approval Process
And more

Staff Report detailing conflicts of interest

More conflict of interest links

Merck's Quiet Effort - influencing mandating of chicken pox vaccine in Ohio
Merck paid legislators, hospitals, docs and organizations!


War on Truth: The Secret Battle for the American Mind


"The fear is that the lure of profit could color scientific integrity, prompting researchers to withhold information about potentially dangerous side effects or push for experiments that might not be quite safe."


Many articles on conflict of interest
Rezulin Dangers Withheld
"The FDA is reviewing accusations that the manufacturer of the diabetes drug Rezulin withheld evidence of liver toxicity from the agency until six months after Rezulin was marketed. A spokeswoman for the agency said it would look into accusations by Public Citizen's Health Research Group, a patient advocacy group, that Rezulin's maker delayed telling the FDA that 21 patients had developed liver abnormalities while taking the drug before it was approved. Federal regulations require that drug companies report adverse drug reactions to the drug agency within 15 days of learning about them. In a March 14 letter to the agency, Public Citizen requested a criminal investigation of the manufacturer, Parke-Davis, division of the Warner-Lambert Company of Morris Plains, NJ"


Editorial Reply Re: Congressional Hearings on Vaccines and Autism

Mandating Vaccines: Government Practicing Medicine Without a License?

From: Dawn Richardson, PROVE

This is a phenomenal letter written by a parent of a vaccine injured child in response to an editorial comment published on WebMD. It clearly illustrates the incestuous ties some of those who make vaccine decisions for our children have with drug companies. These are the very people who are critical of the parents and elected representatives who are doing such a great job shedding light on some of the dangers of vaccines because of the threat the truth poses to their pocketbooks. The internet (source of all this information) is a wonderful thing.

----------------------------------------- In Reply to Editorial Comment from: Wayne L. Pines Re: Congressional Hearings on Vaccines and Autism

Wayne L. Pines, you belittle Congressman Burton as an "angry grandfather" when his goal is to make vaccines safer for children. Your feeble attempt to undermine Congressman Burton's efforts made sense only after your ties to the vaccine manufacturers and drug companies were revealed. This is a day in your life Wayne L. Pines. Let's see who you really are and then people will understand that your words are meaningless because they are motivated by avarice.

You started your career in Washington as the associate editor for The Pink Sheet a pharmaceutical trade magazine. Then you went to work at the FDA for 10 years from 1972 to 1982. Your next job was with the PR firm Burson-Marsteller. After that, you got a job with APCO Associates. Then you joined a company called Therametrix (1). In between you became involved with various pharmaceutical trade groups such as the Food and Drug Law Institute (2), the Drug Information Association (3), and the Internet Healthcare Coalition (4).

Now let's start connecting the dots to see why you would not want a public discussion about how to improve the safety of our children's vaccines. We'll pick-up your career after you leave the FDA. You immediately landed a job with the PR firm Burson-Marsteller (a subsidiary of the advertising agency Young & Rubicam). Your title there was executive vice president. Marsteller clients include Monsanto and their bio-engineered foods and Dow-Corning and their silicon breast implants. In addition, Marsteller has several large drug companies as clients including Eli Lilly. Lilly produces the drug Prozac which has accumulated more adverse reaction reports than any substance (besides vaccines) in the history of the FDA's adverse drug reporting system. Documents released under the Freedom of Information Act challenged the veracity of Prozac's clinical trials that led to FDA approval. Lilly's PR firm Burson-Marsteller was called in to do damage control. There, according to the Campaign Against Fraudulent Medical Research, it was reported that you helped Lilly get past its troubles by exploiting your contacts with current FDA officials (5).

You then became president of the Health Care Practice of APCO Associates a "communications consulting firm." According to PR Watch, APCO Associates specializes in setting up front groups and coalitions for the tobacco and insurance companies (6). In fact, APCO's website boasts that "excellence in public affairs and public relations, like excellence in art, is about the power of communication" (7). No it's not. Excellence in public affairs is about honest communication and adding substance to the public discourse. It's what Congressman Burton is doing. It's not about ridiculous, crude and poorly veiled attempts to protect and further your client base. You may think excellence in public affairs and public relations is about power, but power won't help you when it comes to our children. As much as it may disturb your plans, parents will not sacrifice the health and lives of their children in order to drive up the stock prices of your drug company clients.

Next you joined Therametrix whose website gloats that "Wayne L. Pines is a world-renowned health care consultant (who) has consulted for virtually all of the major pharmaceutical companies..."(1). It also states that Therametrix is a "medical marketing research agency that serves the pharmaceutical, biotechnology, medical device and consumer health products industries" (8). Your clients are listed as including: Abbot Laboratories, Bayer, Bristol-Myers Squibb, Du Pont Pharmaceuticals, Eli Lilly, Glaxo Wellcome, Novartis Pharmaceuticals, Pharacia & Upjohn, Procter & Gamble Pharmaceuticals, Roche Laboratories, Schering-Plough, Triangle Pharmaceuticals and Warner Lambert - all of them drug and vaccine manufacturers (9). Your company's mission statement declares, "We see nothing more important than meeting our client's needs" (9). I don't doubt it.

You are also on the marketing and advertising committee of the Drug Information Association which describes itself as a "member-driven scientific association with a membership of over 22,000 primarily from the regulatory agencies, academia, contract service organizations, pharmaceutical, biological and device industry, and from other health care organizations" (10). Who are some of the other committee members in the Drug Information Association? They include Dr. R. Venkataraghaven of Lederle Laboratories (3) manufacturer of Orimune, Tetramune and other vaccines, Dr. Elizabeth B. D'Angelo of AstraZeneca (3), and Dr. John F. Bedard of Bristol-Myers Squibb (3). The board of directors include Stuart W. Cummings of Merck, Sharp & Dohme manufacturer of the vaccines associated with autism - MMR, MR Vax, Meruvax II, Mumpsvax, Varivax and others, Francoise de Cremiers of Wyeth-Ayerst another major vaccine manufacturer, Charles C. Depew of SmithKline Beecham, Brenton James of Glaxo Wellcome, Murray Lumpkin of the FDA, and Irwin G. Martin of Parke-Davis (11).

In addition, you are a member of the Food and Drug Law Institute which describes itself "as a private organization, not affiliated with the FDA.(but our) mission, however, does relate to the activities, policies and procedures of the FDA..."(12). As a participant in this institute you work with the other members, and in fact, you are scheduled to moderate one of the institute's conferences on medical technology, drugs and biologics (i.e. vaccines) in June of this year (2). Nearly every drug company including the major vaccine manufacturers is a member of this organization. The list includes: American Home Products (i.e. Lederle), Bayer, Medeva Pharmaceuticals, Merck & Co., Organon Teknika, and SmithKline Beecham.

I could go on and on about your affiliations with vaccine manufacturers and drug companies but I believe the point has been made ad nauseam.

One of Congressman Burton's assertions is that an inherent conflict of interest may exist amongst the people who decide what gets injected into our children's veins. The Congressman understands that many of the individuals in our halls of government who make health decisions affecting our children get money from the very drug companies they are supposed to be regulating. During the hearings, when Coleen Boyle of the CDC was asked if she thought there was anything wrong with such a conflict she was literally speechless. Wayne L. Pines your behavior is a text book example of what Congressman Burton and tens of thousands of parents disdain.

As a former employee of the FDA you use your clout to influence what should be a scientifically sound, reasonable and objective decision making process. But even with all of your industry's money and consultants and PR firms and communication experts and doctors on payrolls you are still missing one key ingredient - the truth. The truth can't be bought, spun, manipulated, or turned into a sound bite. Parents know the truth when they watch their children become ill, disabled and die. So despite your supreme efforts to sell more vaccines, we will not allow some greedy industry to decide what is safe and to dictate to us what should be put into our children's bodies.

Wayne L. Pines go back to your "medical marketing research agency" and your "communications consulting firm," shut up, and leave our children alone.

Sincerely,

Michael Horwin Father of Alexander - a vaccine injured child who passed away at the age of 2 ½ years old

Footnotes:
1) http://www.therametrix.com/staff.html:
http://www.therametrix.com/wayne.html:
2) http://www.fdli.org/conf/medsymagd.htm:
3) http://www.diahome.org/dhp2d12.htm:
4) http://www.ihealthcoalition.org/content/fda_1.html:
5) http://www.pnc.com.au/~cafmr/newsl/prozac.html:
6) http://www.prwatch.org/prw_issues/1996-Q3/index.html:
7) http://www.apcoassoc.com/gallery/gallery.html:
8) http://www.therametrix.com/company.html:
9) http://www.therametrix.com/clients.html:
10) http://www.diahome.org/:
11) http://www.diahome.org/dhp2c.htm:
12) http://www.fdli.org/about/index.html:


Last Monday week, ABC TV had a story on Lateline about the control that the drug industry has taken of medical research.

Dr Marcia Angell, former editor of the New England Journal of Medicine, was interviewed. She says many significant things, but note this in particular as the core of it:

"It used to be that drug companies simply gave grants to academic medical centres for the use of their clinical researchers to do a study and that was it. It was at arm's length. The researcher did a study and he or she published the results, whatever those results would be. Now, it's very, very different. The drug companies increasingly design the studies. They keep the data. They don't even let the researchers see the data. They analyse the data. They decide whether they're going to even publish the data at the end of it. They sign contracts with researchers and with academic medical centres saying that they don't get to publish their work unless they get permission from the drug company. So, you can see that the distortion starts even before publication. It starts in determining what's going to be published and what isn't going to be published. This is no longer arm's length. It's treating the researchers and the academic medical centres as though they were hired guns or technicians or something. They just do the work. And the drug company will decide what the data show, what the conclusions are and whether it will even be published."


Critique of Government-Funded Epidemiology Harris Coulter


Medical Control, Medical Corruption


Financial Support to the Immunization Action Coalition
Deborah L. Wexler, MD
Executive Director
Immunization Action Coalition
**publisher of NEEDLE TIPS, VACCINATE ADULTS! and IAC EXPRESS**
1573 Selby Avenue, Suite 234
St. Paul, MN 55104
Phone: (651) 647-9009
Fax: (651) 647-9131
E-mail: deborah@immunize.org
http://www.immunize.org/
IAC EXPRESS: http://www.immunize.org/express/
-------------------------------------------------------------
Groups That Provide Financial Support to the Immunization Action Coalition in 1999

During 1999 the following groups provided funds to IAC: Government:
Centers for Disease Control and Prevention

Private Sources:
Approximately two thousand private individuals

Professional Organizations:
American Pharmaceutical Association

Corporations:
Chiron Corporation
GlaxoWellcome
Merck & Co.
Nabi
North American Vaccine
Pasteur Merieux Connaught
SmithKline Beecham
Wyeth Lederle Vaccines


The New England Journal of Medicine has a policy of disclosing authors' conflicts of interest, but sometimes the conflicts are too long to print! Here are the conflicts for just one article in the current issue where the authors are all academics.

http://www.nejm.org/content/2000/0342/0020/1462.asp

Supported by Bristol-Myers Squibb. Dr. Keller has served as a consultant to or received honorariums from Pfizer, Bristol-Myers Squibb, Forest Laboratories/Parke-Davis, Wyeth - Ayerst, Merck, Janssen, Eli Lilly, Organon, and Pharmacia - Upjohn. He has received research grants from Wyeth - Ayerst, SmithKline Beecham, Upjohn, Pfizer, Bristol-Myers Squibb, Merck, Forest Laboratories, Zeneca, and Organon. He has served on the advisory board of Wyeth - Ayerst, Pfizer, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories/Parke-Davis, Organon, SmithKline Beecham, Merck, Janssen, Mitsubishi Pharmaceuticals, Zeneca, Scirex, and Otsuka. Dr. Klein has served as a consultant to Bristol-Myers Squibb. Dr. Dunner has served as a consultant to Bristol-Myers Squibb, SmithKline Beecham, Glaxo Wellcome, and Eli Lilly. He has received research grants from Bristol-Myers Squibb, Pfizer, Pharmacia - Upjohn, SmithKline Beecham, Forest Laboratories, Glaxo Wellcome, and Wyeth - Ayerst. He has received speaker's honorariums from Bristol-Myers Squibb, SmithKline Beecham, Glaxo Wellcome, Eli Lilly, Organon, and Wyeth - Ayerst. Dr. Gelenberg has received grants and research support from Bristol-Myers Squibb, Organon, Pfizer, Lilly Research Laboratories, Janssen, Merck Sharp Dohme, SmithKline Beecham, Wyeth - Ayerst, Hoechst Marion Roussel, and Forest Laboratories. He has been a member of speakers' bureaus sponsored by Bristol-Myers Squibb, Pfizer, SmithKline Beecham, Janssen, Lilly, Forest Laboratories, and Parke-Davis. He is a stockholder or has other ownership interest in Pfizer, Warner-Lambert, and Eli Lilly. He has served as a consultant to Eli Lilly, Scios, Forest Laboratories, Parke-Davis, Pfizer, Janus Pharmaceuticals, Best Practice, and Bristol-Myers Squibb. Dr. Markowitz has received speaker's honorariums from Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Organon, and Pfizer. Dr. Nemeroff has been a consultant to or received honorariums from Abbott, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories, Janssen, Eli Lilly, Merck, Mitsubishi, Neurocrine Biosciences, Organon, Otsuka, Pfizer, Pharmacia - Upjohn, Sanofi, SmithKline Beecham, Solvay, and Wyeth - Ayerst. He has received research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories, Janssen, Eli Lilly, Organon, Pfizer, Pharmacia - Upjohn, SmithKline Beecham, Solvay, and Wyeth - Ayerst. Dr. Russell has been a consultant to or received honorariums from Abbott, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Quintiles. He has received research support from Abbott, Bristol-Myers Squibb, Eli Lilly, Parke-Davis, Pharmacia - Upjohn, Pfizer, SmithKline Beecham, Wyeth - Ayerst, Shire, and Quintiles. Dr. Thase has served as a consultant to Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Glaxo Wellcome/Cerenex Pharmaceuticals, Merck, Organon, Pfizer, Pharmacia - Upjohn, and Wyeth - Ayerst. He has received grant and research support from Bristol-Myers Squibb, Lipha Pharmaceuticals, Merck, Organon, Pharmacia - Upjohn, and Wyeth - Ayerst. He has been a member of speakers' bureaus sponsored by Bristol-Myers Squibb, Eli Lilly, Forest Pharmaceuticals, Glaxo Wellcome/Cerenex Pharmaceuticals, Organon, Parke-Davis, Pfizer, Pharmacia - Upjohn, SmithKline Beecham, Solvay, and Wyeth - Ayerst. Dr. Trivedi has received research grants from Abbott, Akzo (Organon), Bayer, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Glaxo Wellcome, Janssen, Johnson & Johnson, MeadJohnson, Parke-Davis, Pfizer, Pharmacia - Upjohn, Solvay, and Wyeth - Ayerst. He has been a member of speakers' bureaus sponsored by Bristol-Myers Squibb, Forest Laboratories, Pharmacia - Upjohn, Solvay, and Wyeth - Ayerst. Dr. Zajecka has received grants and research support from Abbott, Bristol-Myers Squibb, Eli Lilly, Glaxo Wellcome, Organon, Otsuka America, Parke-Davis, Pfizer, Pharmacia - Upjohn, and Sanofi Research. He has served as a consultant to or has served on the advisory board of Abbott, Bristol-Myers Squibb, and Eli Lilly. He has been a member of speakers' bureaus sponsored by Abbott, Bristol-Myers Squibb, Eli Lilly, Pfizer/Roerig, SmithKline Beecham, Upjohn, and Wyeth - Ayerst. Dr. Blalock has served as a consultant to Bristol-Myers Squibb. Dr. DeBattista has been a member of speakers' bureaus sponsored by Abbott, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Glaxo Wellcome, Parke-Davis, Pfizer, Scios, SmithKline Beecham, Wyeth - Ayerst, and Organon. He has received grants and research support from Abbott, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Glaxo Wellcome, Pfizer, the National Alliance for Research on Schizophrenia and Depression, Pharmacia - Upjohn, PharmaPrint/ABA, SmithKline Beecham, and Wyeth - Ayerst. He has served as a consultant to Bristol-Myers Squibb, Eli Lilly, Glaxo Wellcome, and PharmaPrint. Dr. Fawcett has received grants and research support from Abbott, Bristol-Myers Squibb, Glaxo, Eli Lilly, Organon, Pfizer, SmithKline Beecham, Wyeth - Ayerst, and Zeneca. He has served as a consultant to Abbott, Bristol-Myers Squibb, Eli Lilly, EM Industries, Forest Laboratories, Glaxo Wellcome, Pfizer, Pharmacia - Upjohn, and SmithKline Beecham. He has been a member of speakers' bureaus sponsored by Abbott, Bristol-Myers Squibb, Eli Lilly, Pfizer/Roerig, Pharmacia - Upjohn, SmithKline Beecham, and Wyeth - Ayerst. Dr. Hirschfeld has received grants and research support from Abbott, Bristol-Myers Squibb, Organon, and Pfizer. He has served as a consultant to or on the advisory board of Abbott, Bristol-Myers Squibb, Glaxo Wellcome, Forest Laboratories, Eli Lilly, Pfizer, SmithKline Beecham, Janssen, Organon, Parke-Davis, and Pharmacia - Upjohn. Dr. Kocsis has had research contracts with Bristol-Myers Squibb, Pfizer, Forest Laboratories, Eli Lilly, and Wyeth - Ayerst. He has received speaker's honorariums from Bristol-Myers Squibb, Forest Laboratories, and Eli Lilly. He owns stock in Pfizer and Forest Laboratories. Dr. Kornstein has received research grants from Bristol-Myers Squibb, Pfizer, Eli Lilly, Glaxo Wellcome, Forest Laboratories, Mitsubishi Pharmaceuticals, and Biovail. She has served as a consultant to Bristol-Myers Squibb, Pfizer, Eli Lilly, and Pharmacia - Upjohn. She has received honorariums from Bristol-Myers Squibb, Pfizer, and Glaxo Wellcome. Dr. Ninan has received grants and research support from Abbott, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Organon, Pharmacia - Upjohn, SmithKline Beecham, and Solvay. He has served as a consultant to Pfizer, TAPPharma, and Wyeth - Ayerst. He has been a member of speakers' bureaus sponsored by Abbott, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Organon, Parke-Davis, Pfizer, Pharmacia - Upjohn, SmithKline Beecham, Solvay, Janssen, and Wyeth - Ayerst. Dr. Rothbaum has served as a consultant to Bristol-Myers Squibb and Pfizer. She has been a member of the advisory board of and a speakers' bureau sponsored by Pfizer. Dr. Rush has received grants and research support from Abbott, Bristol-Myers Squibb, Cyberonics, Eli Lilly, Forest Laboratories/Parke-Davis, Glaxo Wellcome, Janssen, Novartis, Organon, Pfizer, Pharmacia - Upjohn, SmithKline Beecham, Wyeth - Ayerst, and Zeneca. He has served as a consultant to Bristol-Myers Squibb, Cyberonics, Eli Lilly, Forest Laboratories/Parke-Davis, Glaxo Wellcome, Janssen, Merck, Organon, Pfizer, Pharmacia - Upjohn, and Wyeth - Ayerst. He has been a member of speakers' bureaus sponsored by Abbott, Bristol-Myers Squibb, Cyberonics, Eli Lilly, Forest Laboratories/Parke-Davis, Glaxo Wellcome, Organon, Pfizer, Pharmacia - Upjohn, and Wyeth - Ayerst. Dr. Schatzberg has served as a consultant to or received honorariums from Abbott, Bristol-Myers Squibb, Corcept Therapeutics, Forest Laboratories, Janssen, Eli Lilly, Merck, Mitsubishi Pharmaceuticals, Organon, Parke-Davis, Pfizer, Pharmacia - Upjohn, Sanofi, Scirex, SmithKline Beecham, Solvay, and Wyeth - Ayerst. He has received research support from Bristol-Myers Squibb, Pfizer, and SmithKline Beecham. He has equity ownership in Corcept, Merck, Pfizer, and Scirex.

Medical Monopoly Information

The Medical Monopoly: Protecting Consumers or Limiting Competition? Sue A. Blevins

The Medical Monopoly: Your Tax Dollars Limit the Competition by Richard Leviton


Merck paid legislators, hospitals, docs and organizations!

4/16/200 Akron (Ohio) Beacon Journal

Merck's quiet effort
Vaccine maker backs legislation

BY ROGER J. MEZGER
Beacon Journal medical writer

When Dr. Arthur Lavin's young patients turn 15 months old, he sits down with their parents and talks about chickenpox.

The Beachwood pediatrician explains that a vaccine to prevent the itchy, scabby childhood disease has been available since 1995. He tells them that the American Academy of Pediatrics and a federal Centers for Disease Control and Prevention advisory committee want all children to have the vaccine.

Then he lets the parents decide whether their child should have it.

"What I tell the parents is, generally speaking, the child is probably going to be just fine without the vaccine, and they'll probably be just fine with the vaccine," Lavin says.

By next year, Lavin might not have to explain and parents might not have to decide. Legislation working its way through the General Assembly would require all

Ohio children 12 or younger who have not had chickenpox

Backers of the legislation say chickenpox is deceptively dangerous. They cite 5-year-old CDC estimates that 4 million cases of chickenpox break out in the United States each year, that as many as 100 people die after contracting the highly contagious disease -- about half of them children -- and that thousands more are hospitalized with complications. Still, Lavin says, "In childhood, there's no question that the vast majority of chickenpox cases are innocent -- cause no harm at all."

Lavin describes himself as a mainstream doctor, active in the Ohio chapter of the American Academy of Pediatrics and a founder of the Cuyahoga County Immunization Registry, a computerized system that will track the vaccination history of every child in the county.

"Nearly all immunizations are overwhelmingly beneficial," he says, such as the vaccines against diphtheria, tetanus and whooping cough that all babies get. "But I don't look at immunizations as all equal." Since the chickenpox vaccine came on the market in 1995,

Lavin has observed a trend that troubles him: "Over the last five years," he says, "there's been a greater and greater move toward redefining chickenpox as a dangerous disease."

Merck is sole maker
The only vaccine against chickenpox -- or varicella zoster virus, in medical terms -- is made by Merck & Co. Inc. of Whitehouse Station, N.J. More than 20 million doses of the vaccine, called Varivax, have been given since it won U.S. Food and Drug Administration approval in 1995, the CDC says. In Ohio, a public relations campaign to support mandatory chickenpox vaccination got under way in Columbus earlier this year, around the time the bill was introduced in the state Senate. The names of several professional groups concerned about child health issues, including the American Academy of Pediatrics, were associated with the campaign. What wasn't evident, however, was that the money to pay for that effort came indirectly from Merck.

Merck, the nation's largest pharmaceutical company, reported more than $32 billion in sales last year. Its lineup of popular drugs includes the pain reliever Vioxx, the asthma drug Singulair and the baldness treatment Propecia.

Compared with those profitable products, said Merck spokeswoman Isabelle Claxton, the company's vaccine business "is literally a blip on our financial landscape. It's a very small piece of the franchise. It's worth less to the company than some of our single medicines."

Vaccines and related preventive products, including Varivax, accounted for $860 million of Merck's sales last year. By comparison, Vioxx sales alone could top $1 billion this year.

But Varivax and those bigger-name products do have something in common: All have gone on the market since 1995. And according to an analysis by Best Practices LLC, a North Carolina business consulting firm, products introduced in the past five years account for 22 percent of worldwide sales in Merck's human health division.

Bringing new products to market runs up huge research and development costs that need to be recovered. Merck spent more than $2 billion on R&D last year. To help assure a product's success among doctors and consumers, the Best Practices study says, drug companies have modified their marketing strategies to take advantage of the influence of "thought leaders" in health and medicine.

Thought leaders include patient advocacy groups with names the public recognizes: the American Heart Association and the National Institutes of Health, for example. These groups promote patients' interests and enjoy great credibility among consumers, says Best Practices manager David Wang, who led his company's study of successful product launches by the drug industry.

The way it works, Wang says, is that a drug company approaches patient advocacy groups with results of clinical studies showing the effectiveness of its new product. Working in collaboration with the drug companies, he says, these advocacy groups do not endorse the product but concentrate their efforts on educating the public about the condition the product helps.

In this way, the drug companies "really use them almost like a third-party advocate for their new products," Wang says.

Creating a coalition
The Chicago-based American Academy of Pediatrics has taken the lead nationally in advocating the chickenpox vaccine for children. The academy and the CDC's Advisory Committee on Immunization Practices both have urged states to require the vaccine before a child is admitted to day care or school.

Columbus public relations executive Chan Cochran says he met in January with lobbyists for Merck and the Ohio chapter of the American Academy of Pediatrics to talk about promoting the chickenpox vaccine. At about the same time, Children's Hospital of Columbus asked Merck for a $40,000 educational grant to promote childhood health and immunization issues. Merck approved the grant, and Children's hired Cochran's firm to produce 2,000 copies of a brochure endorsing the mandatory immunization of Ohio children against chickenpox. Money from the Merck grant covered the cost of the brochures, the hospital says.

But before the brochures were printed, Cochran says, he suggested enlisting the support of other groups interested in children's health issues.

"It wasn't going to go anyplace until there were some other partners involved," Cochran said. He added the names of the Ohio chapter of the Children's Defense Fund, the Association of Ohio Children's Hospitals and the Association of Ohio Health Commissioners to the brochure and called the group the Ohio Varicella Vaccine Coalition. "Chan called me and said they're interested in dropping a bill in," said Jerome Friedman, a lobbyist for the Association of Ohio Children's Hospitals. "We talked about the potential for progress of such a bill in an election year and a short (legislative) session and such."

Cochran described the vaccine coalition as "sort of a loose-knit group of supporters of the issue." "The only reason the word 'coalition' ever came up was that there came to be the need to put something on the brochure as to where it had come from," he said.

PAC contributions
Some of the coalition's brochures wound up in the office of Sen. Bruce Johnson, R-Westerville, who introduced the chickenpox vaccine bill Feb. 15 in the Senate Health, Human Services and Aging Committee. Johnson says he was unaware that Merck money had paid for the brochures, but he sees no problem with that. "This legislation is about protecting children from varicella, from getting what is a communicable disease that causes death, that can be prevented," he said.

But in addition to funding the grant that paid for the brochures, Merck money is in the background of the Ohio chickenpox debate in another way. In November, Merck's employee-funded political action committee made campaign contributions totaling $2,150 to nine Ohio legislators, according to the Ohio secretary of state's office. Among them are four members of the Republican majority on the Senate Health, Retirement and Aging Committee, including Johnson. That committee's vote on the vaccine bill this year will determine whether it goes before the full Senate.

Other recipients included the House speaker pro tempore and the House majority whip, both Republicans, as well as the Ohio House GOP Caucus. Republicans control both houses of the Ohio General Assembly. "A decision to support a candidate through the PAC is based on a general range of criteria, including the individual's overall position on broad policy issues such as health-care reform, intellectual property protection, environmental law and regulatory reform," Merck spokeswoman Claxton said in a prepared statement.

"Decisions are not based on specific legislative issues."

Johnson said he was unaware of the Merck contributions. "I don't track who makes contributions," he said. "I tend not to care." He said Merck lobbyists began contacting him about the issue "some time ago." Merck lobbyist Robert Kelley said he didn't remember when discussions began, and he referred all other questions to Claxton. Claxton could not provide a figure on how much the company has spent on direct lobbying of Ohio legislators in support of the vaccine bill. She said that in the 22 states where vaccine bills have been passed, Merck spent an average of less than $10,000 on lobbying.

"It is not that the company is not interested in promoting legislation as appropriate," she said. "But I think it would be misleading to say that it's Merck's involvement that makes or breaks these legislative decisions."

Genuine concern
Dr. Christopher Rizzo, president-elect of the Ohio chapter of the American Academy of Pediatrics, is a strong supporter of the chickenpox vaccine legislation.

He believes people have been lulled into thinking chickenpox is a routine disease even though it sometimes can become a serious problem. Rizzo, a pediatrician at Children's Hospital Medical Center of Akron, testified in favor of the bill before Johnson's committee last month on behalf of the Ohio Varicella Vaccine Coalition, the group whose name appears on the brochures that were paid for with money from Merck.

But Rizzo also works with the Ohio Network on Immunization Information, another recently formed group of pro-vaccine health professionals. The network's goal is to present scientific, objective information showing that vaccines are safe, effective and beneficial, said Ann Whitlach, executive director of the Ohio Nurses Association, one of the groups that formed the network. To that end, the network will not use data from studies that were paid for by parties with commercial interests, she said, and will not ask for or accept money from drug companies.

"We know, bottom line, that the public will believe it more," Whitlach said.

Rizzo says Merck's involvement with the Ohio Varicella Vaccine Coalition may raise concerns about appearances, but it does not affect how strongly he feels about the vaccine issue.

"Having a pharmaceutical manufacturer involved gives the perception of a conflict of interest, even though all of us who are in the coalition, certainly other than Merck, feel very strongly that this is in the interest of children, it's in the interest of the community and in the interest of public health," Rizzo said.

Low risk cited
Lavin, the Beachwood pediatrician, says he doesn't doubt that genuine concern for public health is what led the American Academy of Pediatrics and the CDC to call for mandatory chickenpox inoculations. If the goal is to save the one child in every 40,000-plus who dies after getting chickenpox, he says, then universal immunization is the only way to achieve that.

"Those deaths are tragic, and I'm 100 percent behind preventing them," Lavin said. "It's a terrible tragedy to have a childhood death."

Still, he says, "My perspective is as a pediatrician looking into the eyes of a particular child. And even though there are 40 to 60 (child) deaths a year, that translates into a phenomenally low chance of death, or even harm, from a natural case of chickenpox in childhood."

In fact, he says, "odds are very great that that (vaccinated) child will have gained very little benefit from having chickenpox prevented." Like pediatricians everywhere, Lavin has received his share of "Dear Doctor" promotional kits from Merck pointing out the overlooked dangers of chickenpox. But he's been a tough sell.

"How dread a disease is, is a complex call," he said, noting that "there's been quite a lot of money spent on advertising and promotion" of the vaccine. "To try to change the perception in the eyes of the practicing pediatrician -- is that a right thing to do?"

Roger Mezger can be reached at 330-996-3547 or rmezger@thebeaconjournal.com



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