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Two Schoolgirls Force GlaxoSmithKline to Apologize for Deceptive Food Advertising and to Pay Fine

Two recent studies have noted that alcohol industry advertising has a strong effect on youth and contributes to underage drinking. In January of 2006, the American Medical Association’s Archives of Pediatrics and Adolescent Medicine published a study by Snyder et al which found that the number of alcohol ads viewed was positively associated with the amount of alcohol consumed by youth. Each advertisement viewed raised the number of drinks consumed by 1%.

In 2004, two 14 year old New Zealand school girls, Anna Devathasan and Jenny Suo, tested the Vitamin C levels of their favorite drinks for a school science project. One product, Ribena, made by GlaxoSmithKline(GSK), the world’s second largest drug manufacturer, tested much lower than advertised. GSK had claimed that blackcurrants, Ribena’s main ingredient, had four times the Vitamin C of oranges but according to the girls’ science experiment the beverage had much lower levels.

The girls wrote a letter to the company reporting their findings but got no response. According to Jenny Suo, a telephone call to GSK was equally frustrating. “They didn’t even really answer our questions,” she told a reporter for Aukland’s Weekend Herald. “They just said it’s the blackcurrants that have it, then hung up.” Undeterred, the students contacted business watchdog groups, a television consumer affairs program, and, finally the New Zealand Commerce Commission.

On March 27, 2007, three years later, the company appeared in court in Aukland to plead guilty to 15 charges of making misleading claims about Ribena and breaching the Fair Trading Act. The Commerce Commission fined GSK US $168,000 The commission said that although blackcurrants did have more Vitamin C than oranges the same was not true of Ribena . The commission found that ready-to-drink Ribena had no detectable level of Vitamin C. Paula Rebstock, the commission chair, said thousands of New Zealanders had been duped by the company and described the company’s behavior as “a massive breach of trust with the New Zealand public.”

Before the New Zealand decision, GlaxoSmithKline, which has a worldwide turnover of more than $40 billion year, reported itself to the Australian Competition and Consumer Commission. GSK agreed to the Australian Commission’s suggestion that it correct its labeling, cease making claims about Vitamin C, and publish an article in an industry magazine on the importance of accuracy in advertising.

At the Aukland court hearing, Anna Devathasan expressed concern and satisfaction about the outcome. “They’re a multi-billion dollar company,” she told the Sydney(Australia) Morning Herald, “so it’s a bit disappointing, but I think their reputation has been damaged enough to have an effect.”

Interview with John Johnson, Executive Director, Iowans for the Prevention of Gun Violence on the Campaign to Close the Newspaper Loophole

In March 2007, Cho Seung-Hui, a Virginia Technical University student, walked into a gun store in Roanoke, VA., and paid $571 for a Glock 9-millimeter handgun and a box of ammunition. A few weeks earlier he had purchased a Walther .22-caliber semiautomatic pistol at a pawnshop. On April 16th, the student used these weapons to kill 32 people and then himself, leaving the highest death toll of any such shooting episode in U.S. history.

The massacre in Blacksburg, Virginia, again focused media and public attention on the practices of the U.S. gun industry and its allies. One continuing issue has been the retail practices of gun sellers and the degree to which the gun industry monitors the sales of its products. In this report, we excerpt an interview, conducted in August 2006 (before the Virginia shooting) by Corporate Health Watch staff member Sarah Bradley with John Johnson, Executive Director of Iowans for the Prevention of Gun Violence, a founder of the national Campaign to Close the Newspaper Gun Loophole. This Campaign seeks to persuade newspapers around the country to refuse gun advertisements from unlicensed dealers.

CHW: Gun control advocates have used several strategies to restrict access to lethal weapons and reduce the harm from gun violence. What made you decide to focus on newspaper advertising of guns? After all, newspaper ads aren’t the biggest source of guns, are they?

JJ: No, newspapers are probably not the biggest source of guns. And we can see that, yes, there are probably more sales through gun shows and the internet, but the reason we focused on newspapers — I think this is important — is that it doesn’t require legislation. To close the “internet loophole” would require legislation. Closing the newspaper loophole doesn’t take an act of Congress. All it takes is a management decision. And gun ads are probably a very small source of the total income for the newspaper. That’s another factor that helps. Whereas if you went to people who do internet sales that’s their whole business. So you’re trying to get them to change their whole business. When we go to newspapers, we’re trying to get them just to change a tiny part of their business. So that’s why we focused on newspapers. Not that they’re the biggest source, but it’s an area where we thought we could have some success, and we have had some success. This sends an important message when newspaper publishers do make a change.

As a small group with two and a half staff and not a lot of money, the Campaign to Close the Newspaper Loophole made a decision not to focus on state and federal legislation, but to work on what we called non-legislative initiatives. When we get a newspaper to change, to us that means, “Okay, that’ll be 100 gun ads that won’t be sold through the newspaper this year.” We look at it as more than just the 100 guns that won’t be sold through the newspaper. We look at it as here’s a business that has made a responsible decision on the way they conduct their policies. The Campaign to Close Newspaper Loopholes shows that these businesses recognize the concern and have taken appropriate action, setting a good example for other newspapers and other businesses.

As I said before, I think the legislative strategy can change with the legislature. Right now, the legislatures are not friendly, throughout. And, therefore, I’d say at this point, it’s just a pragmatic decision. We just don’t think we could accomplish anything legislatively. You know that could change. We hope it will change. To pass a law in Iowa with the legislature, I have to get 100 people to vote. And they’re worried that if they vote this way, they’ll lose their job or something like that. Whereas to get 30 newspapers to change, all I have to do is go to 30 newspapers. So in my mind, it’s just a pragmatic decision. To use a football analogy, you “take what the defense gives you.” You know if they put ten men on the line of scrimmage, then you’re going to have to pass. Whereas, if they drop everybody off the line to cover the pass, then you need to run. So the strategy to go to the publisher is really an opportunity that we see is out there. These other opportunities don’t seem to be as realistic.

CHW: Can you give me some examples of how you approach newspaper publishers? What do you say and how do the publishers respond?

JJ: During the summer of 2002, I learned about a series of articles in the Detroit Free Press about the high number of homicides among teenagers in the city, mostly from firearms. From our previous survey, we knew this was a newspaper that took classified ads for all guns…shotguns, even hand guns from unlicensed dealers. Since the Detroit Free Press is a progressive newspaper in a large metropolitan city that generally has higher rates of crime than smaller cities and rural areas, and a paper that brought this issue to the attention of their readers, we thought it was a good candidate to change their policies. We always felt that the reason newspapers took gun ads was because they just hadn’t given it a lot of thought.

I contacted the President of the Detroit Million Mom March chapter. They’re a gun control organization, part of the Brady Campaign. And I explained to her about what our campaign to close the newspaper loophole was, asking newspapers to voluntarily refuse classified ads for guns, and to see if she would work with me to try to bring this issue to the attention of the management of the newspaper. She agreed to do that, and more than that, she put together a coalition of local activists ….

Ms. Hamilton sent a letter to the publisher of the Detroit Free Press, making the case for closing the loophole and asking for a meeting. We had a meeting with the management of the newspaper where all these local organizations went in and made the case. The next day the paper called up and said they’re going to change their policy.

CHW: That’s a great story — is it always that easy?

JJ: Another example comes from Florida, the Sarasota Herald Tribune. You couldn’t ask for an example that better shows the danger from these ads. A man was involved in a contentious divorce and child custody dispute with his spouse, purchased a semi-automatic hand gun from an unlicensed seller through a classified ad in the Sarasota Herald Tribune. On the same day that he bought the gun, which was a Sunday morning, he went to the home where his estranged wife was living and shot and killed her in front of their nine-year old daughter.

What made this incident interesting for us was that the murder was recorded in the newspaper; but the newspaper story never really reported how he got his gun. A person in Sarasota, Florida, read in the newspaper that after the shooting, the police executed a search warrant of the man’s house where they recovered newspaper ads and a gun receipt. But the article never said that he bought the gun from an ad in our newspaper. So this person in Sarasota sent me an email saying we might be interested in this. So we started working on this on our own. We called the sheriff’s office to see if they would give us information, and they said, “Well, the guy’s busy” and it was kind of a difficult. We looked at some court records online, and we were able to find out that the person who sold the gun was a man named John Spearman. We tried to find him through Internet searches and telephone books but that didn’t work. But I happen to have a cousin who lives in Bradenton, Florida, where this shooting happened. And I called her and said, “You know we think that somebody bought a gun through an ad in a local newspaper” and I asked her to go to the library and make copies of the ads for that weekend. I figured if he bought the gun it was probably an ad that weekend. So my cousin went to the library and sent me ads from the two local papers and we also finally got a hold of the Sherriff’s office, and they told us what kind of a gun was used; and we were able to match them up and confirmed that it was an ad from the Sarasota Herald Tribune. So I called this John Spearman and asked him if he sold the gun to the shooter. And he said, “Yea, I did. And you know what? That stupid idiot went and shot and killed somebody with it.”

So then we wrote a letter to the Editor/Publisher of the Sarasota Herald Tribune. We said, “An ad in your newspaper was the source of this gun,” and we made the request to close this loophole. We also wrote letters to about twenty other newspapers in Florida saying “An ad in the Sarasota Herald Tribune was the source of the gun used in a murder. You ought to consider changing your policies.” After sending that letter we started calling editors and set a date for a press conference. We were going to hold a press conference to increase public awareness of this concern. And when we called the Sarasota Herald Tribune, they said, “We have decided to change our policy.” In fact, they ran a front page story before our press conference telling their readers that they were changing their policy.

CHW: Did you get any other papers in Florida?

JJ: Yes, we got four or five other Florida newspapers out of those twenty.

CHW: I noticed that over the years your campaign changed its focus from asking newspapers to end all advertising for guns to asking them just to drop classified advertisements by unlicensed gun dealers. Can you explain that change?

JJ: Originally we did ask people just not to take ads for guns. Then we discovered a few newspapers that actually had the restrictive policy of taking ads from licensed dealers only. And we thought that was a better position to adopt. And so since we started our 50 state campaign — to reach newspapers all around the country — our position has been to ask publishers not to take classified ads for guns from unlicensed sellers.

We thought this approach would have broader appeal for a couple of reasons. One, I think it’s an easier position for us to argue. We come across less as anti-gun. And I’ve always felt it’s an easier position to advocate. Second, newspapers find it easier for them to implement. They could say, “Well, we have nothing against guns. It just that we’re concerned about the way they’re sold.” However, when the Sarasota Herald Tribune changed their policy, it was just “We won’t take ads for guns, period.” That’s even better.

CHW: Do a lot of licensed dealers advertise in newspaper classifieds?

JJ: No. Licensed dealers don’t typically advertise in the classifieds. They run retail ads. So by taking this position, not only is it an easier sell but it virtually eliminates all classified gun ads. I think it’s easier to frame the issue. And it’s a much more definitive issue. If a newspaper says “I’m not taking ads for guns”, then they’ve made a moral decision to not take ads for guns. But most people in business don’t want to be against guns because they want business from gun people.

CHW: So what do you think makes it so hard to make progress on developing stricter gun control laws?

JJ: To me, what makes this issue so hard is that everybody is against gun violence. I don’t think anybody is advocating for more violence. Even your most right wing NRA is not advocating for violence. We all agree we would like to have fewer gun deaths and injuries. But where we disagree is “How do you get there?” We have policies we support like a ban on assault weapons and background checks on gun purchases. But there are people in the NRA who believe the way to have lower gun violence is to have everybody carry a gun, and then we’d all be safer because criminals wouldn’t dare rob a store because everybody in the store would be armed even though there’s not much empirical evidence for that kind of perspective.

On this issue, I‘ve always tried to be fact-based. So look at the policy. Is there any reasoned analysis, data or studies that would indicate that it would work? The NRA and other people, they just have things that sound good to them. You know, “more guns, less crime.” It’s been so hard to counter these arguments that have no factual basis.

Spotlight on Corporate Practices: What is the Future for US Auto Industry?

In the recent past, the US auto industry has failed on two critical fronts. It has been unable to compete successfully with Japanese and European auto producers and it has not made fuel-efficient, safe vehicles. As a result, the US auto industry is in deep financial trouble and American cars pollute more and are less safe than those made elsewhere. While many factors contribute to the auto industry’s problems, in this case the decision by auto industry executives to sacrifice public health for profits by focusing on SUVs rather than on safer, more efficient cars ended up hurting rather than helping their own bottom line. Now, however, two recent developments provide advocates, public officials and the auto industry with new impetus to solve both their financial and public health problems. A recent Supreme Court decision and new public opinion polls that show auto worker and public support for more effective public oversight of the auto industry provide advocates with an opportunity to mobilize political support for federal action to encourage the auto industry to make cars that pollute less.

Supreme Court Rules Against Bush Administration and EPA on Greenhouse Gas Emissions

On April 3, 2007 the US Supreme Court ruled that the Environmental Protection Agency (EPA) violated the Clean Air Act when it refused to regulate new vehicle emission standards as a way to reduce air pollutants connected with global warming. The case, Commonwealth of Massachusetts et al v. Environmental Protection Agency, dates from 1999. It began when The International Center for Technology Assessment and other groups petitioned the EPA to set stricter greenhouse gas emissions standards for new cars. The EPA declined the petition four years later and argued that it did not have the authority to regulate greenhouse gases. The agency further asserted that even if it did have such authority, it still might refuse to act because the linkages between greenhouse gases and global warming were still scientifically uncertain. In its 5-4 decision, the Supreme Court rebuked the Bush Administration, finding that the EPA had acted illegally and had violated the Clean Air Act. In a press release issued by the International Center for Technology Assessment, legal director Joseph Mendelson stated “The Court recognized that the debate over global warming has ended and that states and individuals are suffering from global warming injuries and impacts right now.” The decision is being hailed as a landmark environmental ruling.

Survey Shows Majority of Michigan Autoworkers Favor Auto Fuel-Efficiency

On February 28, 2007, the Civil Society Institute (CSI) and 40MPG.org released new research that showed that 67% of Michigan autoworkers agreed with the statement that Washington could “help U.S. automakers be more competitive by increasing the federal fuel-efficiency standard to 40 miles per gallon.” The survey of Michigan residents conducted for CSI by Opinion Research Corporation (ORC) also found that 84% of Michigan residents agreed that the U.S. auto industry was in trouble. When asked to identify the top problems the auto industry was facing, respondents identified the failure of the industry to offer the best technology, including improved fuel efficiency, as the most serious issue. The second highest ranking issue was the over production of fuel-inefficient vehicles, including SUVs. More than half of the respondents strongly agreed that higher federal fuel efficiency standards were needed to reduce dependence on foreign oil, reduce global warming and conserve energy.

The results of this survey were consistent with a prior national survey conducted by ORC for CSI and other CSI/ 40MPG.org research. According to the results of this earlier survey, four out of 5 Americans, including 76% of Republicans and Independents and 86% of Democrats, supported the idea of “Congress taking the lead to achieve the highest possible fuel efficiency as quickly as possible.” While the American public clearly supports the idea of fuel efficient cars, CSI and 40MPG.org’s research illustrates that the number of fuel efficient vehicles (defined as those vehicles with gas mileage of at least 40mpg) dropped from 5 to 2 vehicles between 2005 and 2007. Meanwhile, overseas during the same period, the number of fuel efficient cars available to consumers increased from 86 to 113 demonstrating a clear fuel efficiency gap between U.S. and foreign vehicles. Nearly two thirds of the fuel efficient cars available overseas are produced by U.S. auto manufacturers or foreign manufacturers which do a high volume of sales in the United States. The majority of Americans (88%) felt that U.S. consumers should have access to these vehicles. CSI/40MPG.org’s research indicates that given this support, there is a very large market – 2.5 million U.S. consumers – for these vehicles. While the technology for more fuel efficient cars clearly exists and consumer demand for such vehicles is high, U.S. automakers have failed to adopt different technology. Furthermore, the U.S. government has failed to enact federal fuel efficiency standards that would support its development. With gas pricespredicted to hit nearly $4 a gallon this summer, this reluctance seems all the more troubling.

40 MPG.org is an advocacy campaign to make US motor vehicles more fuel efficient. It is sponsored by The Civil Society Institute, a non profit group that seeks to catalyze public mobilization on important policy issues.

Spotlight on the Pharmaceutical Industry

Recent public and media attention has focused on the various ways that the pharmaceutical industry promotes its products, sometimes at the expense of public health. We describe a few examples here.


Big Pharma on the Big Screen: Pharmaceutical Promotion Goes Hollywood

According to an article on February 25, 2007 in The Philadelphia Inquirer, the new film Innerstate, which focuses on three sufferers of rheumatoid arthritis, psoriasis, and Crohn’s disease, was produced by Centocor, Inc. Centocor is a subsidiary of Johnson & Johnson and is the maker of Remicade, the No. 1 treatment for the chronic diseases featured in the film.

According to Michael Parks, the executive producer of Innerstate and Director of Public Relationsat Centocor, the film is simply another form of patient education: “This is not about Remicade. It’s about elevating public awareness of these conditions.”

However, critics maintain that a movie ultimately staring a pharmaceutical product is the latest and most insidious way of undermining the prescription decision-making process. According to Alexander Sugerman-Brozan, Director of the Prescription Access Litigation Project, the production of Innerstate suggests a “questionable trend in health information.” He added, “We need to be skeptical of disease-awareness campaigns that come from a company with a vested interest.”

As Sugerman-Brozan suggests, through the release of Innerstate, Centocor stands to gain from new demands for their prescriptions. However, because federal standards do not allow the explicit mention of the drug’s name in the film, the risks associated with the drug are also not discussed. Thus, patient demands for Centocor’s products are not based on full disclosure of the side effects consistent with this line of treatment.

In addition to the millions invested in direct-to-consumer (DTC) advertising on TV, radio, and print, movie production for the sole purpose of marketing pharmaceutical products directly to consumers is the latest trend undertaken by the pharmaceutical industry in an effort to increase sales. This practice is often known as “disease mongering.”

Pharmaceutical industry insiders argue that DTC advertising of prescription drugs helps educate patients and encourages dialogue with their doctors, but critics say that DTC advertising misleads consumers into believing they need certain medicines. Furthermore, they argue, DTC advertising is merely a marketing tool to increase sales. According to Charles Medawar of Social Audit, “Once you start advertising prescription drugs to consumers and generating demand from that end, really you just debase the value of evidence completely.” Medawar further explains, “DTC advertising allows for a huge market expansion, with people being prescribed drugs that are unlikely to benefit them. The expansion of the antidepressant market “is a symbol of what happened in this era as [companies] suddenly began to realize the only way [to survive] was through marketing and not through drug innovation.”

New Viagra Ad Campaign Shows Industry Commitment to Help Consumers Make Informed Choices

A new Canadian advertising campaign for Viagra, the erectile dysfunction drug produced by Pfizer, provides new insights into the industry’s claim that Direct to Consumer advertising helps consumers make more informed choices. A recent New York Times article described the latest campaign.

“Viagra spanglecheff?” says a man to a friend at a bowling alley. “Spanglecheff?” his friend asks. “Minky Viagra noni noni boo-boo plats!” the first man replies, with a grin that suggests he is not talking about the drug’s side effects. The ads end with the slogan, “The International Language of Viagra.”

As other drug companies market impotence drugs, Viagra has lost market share. In 2006, total sales for Viagra were $1.7 billion, about half in the United States. According to a representative of the Canadian ad agency that produced the new campaign, “It’s not as though we need to tell people what it does, because they already know. Consumers can fill in the blank for themselves.” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, had a different point of view. “In an ideal world, companies would have to sell drugs based on accurate and balanced information,” he told the New York Times. “That doesn’t seem to work well enough, so instead of that they’re substituting gibberish.”

New Study Shows Most Doctors Accept Gifts from Pharmaceutical Companies

Results of a recent national survey published in The New England Journal of Medicine found that the vast majority of US physicians accepted gifts from pharmaceutical companies. Of the representative sample of 3,167 physicians surveyed, 94 percent had some kind of relationship with a pharmaceutical company. Eighty-four percent reported receiving food or drink from a pharmaceutical representative, while 78 percent reported receiving free samples. Thirty-five percent reported receiving reimbursement for costs associated with professional meetings or continuing medical education, and 28 percent reported receiving payments for consulting, lectures, or enrolling patients in trials. Furthermore, pharmaceutical representatives particularly targeted some specialties: Cardiologists were more than twice as likely as family practitioners to receive payments, although family practitioners met more frequently with pharmaceutical representatives than did physicians in other specialties.

The pharmaceutical industry argues that giving gifts to physicians evolved as a necessary tactic in order to gain the attention of busy physicians and share information about new drugs. However, according to the activist organization, No Free Lunch, such relationships are driving the prescribing practices of physicians. In 2003, the pharmaceutical industry spent approximately $22 billion on marketing to physicians, nearly doubling the $12.1 billion spending in 1999. In response to criticism, in 2005 the industry cut back spending to $3 billion, demonstrating the potential impact of advocacy campaigns. Since the 1990s, the pharmaceutical industry has prohibited such perks as lavish trips for top prescribing doctors and in 2004 stopped paying physicians to attend industry-sponsored dinners and conferences. Additionally, the American Medical Association has also set limits to gift giving and has stipulated that all gifts, such as dinners and free drug samples, should benefit patients. However, both the pharmaceutical industry and the American Medical Association have responded to pressure by setting new guidelines for gifts. Robert Goodman, M.D., founder of No Free Lunch noted, “Gifts are gifts. Whether they benefit patients or not, they’re just freeing physicians’ other income in a way that creates indebtedness.”

No Free Lunch argues that both DTC advertising and the aggressive cultivation of physicians debases prescribing practices because decisions are based on exposure to pharmaceutical marketing practices rather than scientific evidence. Promotional materials, according to the group, do not objectively describe the product but are biased in favor of the drug being marketed. These biased materials may lead physicians to prescribe more expensive or less appropriate drugs. In response, No Free Lunch encourages physicians to reject all pharmaceutical promotional items and gifts, citing evidence that acceptance of such gifts influences physicians’ prescribing behavior and creates a relationship in which the physician will feel “indebtedness” toward the representative.

Interview with Lynda Dee

Lynda Dee is a Drug Development Committee member and founder of the AIDS Treatment Activist Coalition (ATAC). In 2003, ATAC joined forces with a coalition of other AIDS treatment advocates, scientists, doctors, and government officials to create the Norvir Pricing Campaign. Abbott Laboratories had recently announced a more than 500% increase in the price of Norvir, an essential component of combination protease inhibitor therapies for HIV/AIDS. The campaign argued that increasing the price of Norvir, would have a negative impact on AIDS patient care as well as the competitive market for the research and development of new HIV/AIDS therapies. In March 2004, the nonprofit organization Essential Inventions petitioned the NIH to permit competition to produce a generic, low-cost version of Norvir. The NIH subsequently held a hearing on the matter. Lynda Dee gave testimony at this hearing.

While the FDA ruled that it did not have the authority to intervene, Congress subsequently began an investigation into the price increase. Several months ago, Corporations and Health Watch staff member Sarah Bradley spoke with Ms. Dee about her AIDS activism, ATAC, and the general political context around the Norvir campaign. Excerpts are included here.

CHW: When did you start doing treatment activism? Was it with ACT UP?

DEE: I started twenty years ago with “AIDS Action Baltimore,” where I’m from. We started AIDS Action Baltimore down here before there even was an ACT UP.

CHW: As an activist, how have you worked with big pharmaceutical companies?

DEE: Well, we often work with drug companies to initiate expanded access programs so that they can make their drugs available to people who desperately need them before it’s actually FDA approved, which means before they get paid for the drug.

CHW: Can you explain the meaning of phases one, two and three in drug trials and how you worked to change this process in order to expand treatment options?

DEE: Phase one is when they make sure it doesn’t kill you. Phase two is when patients get the maximum tolerated dose. That’s the old way of doing it. And what researchers figure out is whether the drug is excreted more in your liver or the kidneys, or whatever system is involved with that. Because certain systems mean that a drug will have drug interactions or, require that the dose be adjusted because of those interactions.

CHW: Right.

DEE: And companies used to do Phase one. Do that. Finish. Phase two. Do that. Finish. And, you didn’t start the one until you finished the other completely. And what we tried to do was to say, “Look, let’s change the designs of these trials.” Sequential learning is not always the best way to do things when people are dropping dead. So they now have Phase 2-B drugs wherein while they’re doing the dose and looking at the interactions, also at the efficacy, and they use that data to help build better Phase 3 programs. The Phase 3 programs are about getting the drugs into a larger population, between 500 and 2,000 people (in AIDS anyway) to see what affects the drug will have and what other side effects turn up. So the more people you have in the trials, for the longer periods, the more you’ll see of the efficacy or non-efficacy and the side effects.

CHW: So expanded access is mostly about making the trials bigger?

DEE: Well, no. Expanded access comes after Phase 3. We try to get them to start it in conjunction with Phase 3 now. In those testing phases they’re very much trying to rule out different things that might really make the results confounded. So they try to be very scientific and not very patient friendly.

We’ve even pushed for things called OLSS’s, which are open label safety trials, where you give expanded access to the even sicker patients. The FDA wants to see more safety data before they’ll allow this expanded access program. Usually, because they want to make sure you’re really not going to do more harm than good.

I’ll never forget, when AZT was first approved, my husband died from complications of AIDS in 1987 and [it] was only for people that had had pneumocystis. Well, he had two AIDS-defining conditions but neither one was pneumocystis, so he couldn’t have access to AZT.

CHW: Why were they limiting its use to the treatment of pneumocystis?

DEE: Because that’s the only place they had ever tried. We’re about changing the old paradigms: years ago when you first tried AZT, they wouldn’t let you take it in combination with one of the drugs for cytomeglavirus that caused people to have blindness. So either you had a choice of going blind or trying this new medication. It’s very nice to have pristine trial results where you’re in a little jar somewhere, but you’re talking about real people.

CHW: Has the impact of the FDA and the pharmaceutical companies on human rights for people with HIV and access or health changed over the last twenty years?

DEE: To get the pharmaceutical industry to change any of these paradigms was like pulling teeth. These guys are conservative: a lot of money is riding on how they proceed. They’re afraid their drugs won’t get approved and they don’t want to take any chances with the bottom line. You can imagine what lawyers were telling them, or even other scientists.

So they were very afraid to change how they did business. But then they had these crazy activists that would show up and cause a stink and bad press and they had to do something with us. After years of meeting with them, they’ve really come around. They know that they have to deal with us, and it’s just part of the price of doing business.

CHW: How do the pharmaceutical companies react to you in these meetings?

DEE: They don’t know what to expect. They come in, they see a reasonable bunch of people, and they see that these people really have good ideas, they’re smart, they’ve been around sometimes longer than they have, and they’re like, “Oh, wow, this has been a very constructive process.”

CHW: What has it been like to work with academics?

DEE: If the pharmaceutical companies were afraid to change the paradigms for reasons of money and power, the academic investigators were very condescending and acted like, what could we possible teach them? It was really kind of funny.

CHW: And what is your perception of their relationship to the pharmaceutical companies?

DEE: They all worked for pharmaceutical companies. What usually happens is, when you have a new drug, you want to get the foremost researcher or physician that you can find to experiment with your drug [in order] to believe your results. So they get paid for it. That doesn’t mean the pharmaceutical company’s bad, or the investigator is bad.

Now there are a lot of researchers who have a conflict of interest. They own the company’s stocks. The thing of it is, as long as I know that you’re getting that money, maybe I’ll look differently at what you say and how you say it.

CHW: In what capacity did you work with the National Institutes of Health?

DEE: I used to be on the Executive Committee of the AIDS Clinical Trial Group at the NIH, which is the national and now international network of the government’s drug trials for HIV. The NIH is very byzantine — there [are] 22 different institutes; they don’t speak to each other at all. So the people that dealt with this — [the] branch that deals with innovations and new inventions — had never dealt with any community people before.

They treated us like it was day one of the movement instead of 20 years later. They were used to dealing with the universities and the patent issues and all that.

CHW: Tell me more about the announcement regarding the Norvir price increase in 2003.

DEE: They announced this increase over the Christmas holidays because they thought [it] would just pass through without a lot of fanfare. But instead, people were shocked and appalled. It was one of the most egregious increases.

There were a lot of people that had their $300 insurance co-payment increased to a $1,000 copay. And there are a lot of people whose insurance permits them only a certain number of dollars every year for drugs. So if Norvir uses it all up, then what about other necessary prescriptions? They’d have you believe that this 700% price increase had no impact anywhere. I can’t imagine that somebody would think they would be able to get away with this without raising some hackles. I don’t think they ever expected to get the outcry that they got from us.

CHW: And in response, didn’t Abbott announce they were giving Norvir for free to anyone who didn’t have drug coverage?

DEE: Right. That’s the Patient Assistance Program. Of course, we could never get them to say how many people were on their Patient Assistance Program.

CHW: Didn’t Aetna actually sue Abbott and then withdraw the lawsuit two days later?

DEE: Yes, there’s still another lawsuit pending. John Doe vs. Abbott Labs is still alive and well. They actually just won their motion for summary judgment against Abbott. So they may end up in court over this if they don’t settle it.

CHW: How did the decision of the NIH not to allow competition to produce a generic version of Norvir affect the campaign?

DEE: I don’t think we ever thought the petition was going to be granted. It was a way to get PR because that’s what you have to do to get anything noticed. I think that really helped us to get the concessions that we did.

CHW: So was your goal more that Abbott would roll back the price because of the pressure?

DEE: We really thought we’d be more successful in getting them to do that. That’s what we hoped for. And obviously we were extremely disappointed when we weren’t able to do that. We’re still disappointed.

CHW: So from your perspective at ATAC, what do you think was the primary obstacle in getting Abbott to lower the price of Norvir?

DEE: It was money, plain and simple. They were in it to make money, and we didn’t have the power to do anything about it. At the time, ATAC had ten volunteers compared to a pharmaceutical giant — one doing press releases, one doing the actions, and me doing the coordination and getting the testimony together, and it was all we did for months. That we accomplished what we did was unbelievable.

CHW: What were some of your biggest successes?

DEE: We got some Congressional support and one of the Congressional people got the NIH to hold this hearing [which] really put the issue on the map as far as the press is concerned. And if it ain’t in the press, it didn’t happen. It doesn’t affect anybody’s bottom line or market share. The other thing was that we were able to get the docs fired up. I think that made a big difference too because these companies sell their drugs through the sales force that visit[s] each doctor. And to have some doctors say, “Don’t bother coming back,” had a big impact.

CHW: In the Norvir campaign, your organization used different strategies: such as protests, petitions, and marches so you had all kinds of strategy going on. Do you think one was better than the other?

DEE: Who knows? We tried everything we could think of. We have a lot of good minds, just not a lot of money and not a lot of volunteers. We even had stockholders involved in our actions such as religious groups that held large stock portfolios. We’d ask them to go in and vote against certain things.

CHW: Do you think the demographic makeup of people with HIV/AIDs affected the Norvir campaign at all?

DEE: No. I don’t think it affected this particular campaign. I think it affected the government’s response. Reagan’s response was lacking from the beginning. My impression, and [that] of others at that time, was that the Reagan Administration didn’t care about homosexuals and was probably glad it was happening to that community.

They did nothing. I think they felt gays were a throw-a-way population. Same for people of color, drug users, urban populations. That’s my honest opinion.

CHW: So you think that’s pretty much remained unchanged?

DEE: Yes. It’s the syphilis of old, just a lot worse. They just have a problem in knowing how to discuss these kinds of issues. If you take a look at England and Western Europe, the minute there is an idea of an epidemic — they react. In England they sent brochures and pamphlets door-to-door that were very graphic, talked about how to prevent it, and nothing happened in Western Europe like it did here. It was like dynamite here how it spread through certain populations.

I think the devastation could have been avoided if everyone were able to: 1. discuss it clearly and in an adult manner, and 2. cared about the people that were actually getting it. I mean look at that Legionnaires disease outbreak. Two or three people died of it and look at how much money and how crazy they were over that. Or look at this Avian Flu: we’ve never even gotten [it] here. I mean, they just go crazy. But how come they didn’t go crazy over [HIV/AIDs]? I mean millions of people have died because of this.

Same in Africa. Do you think many Americans care what happens to people in Africa? I don’t think they really do.

CHW: What has your relationship been with Abbott Pharmaceuticals [maker of Norvir] since the campaign began?

DEE: They’ve been trying to give money away ever since this happened.

CHW: What do they want to give you money for?

DEE: Whatever we want it for. And you know, we didn’t even ask them for it.

CHW: So they can put it on their corporate response?

DEE: To show how well they get along with community. I don’t care what anyone says, when you take money from somebody, you’re then beholden to them. It’s just that simple.

CHW: So I take it you’re opposed.

DEE: Yes.

CHW: Do you see similarities between the kind of work that you do and campaigns against, say, like the Brady campaign against guns, or campaigns against tobacco companies?

DEE: Those are huge issues to the American public. I think that we’ve been able to accomplish probably just as much if not more as those campaigns with an infinitesimal proportion of the resources that those campaigns have.

CHW: Do you think that the general lack of response regarding the increasing prices of HIV medication has to do with people not relating to it?

DEE: Yes, I think so.

CHW: Some observers have made the argument that the AIDS movement proved that the pharmaceutical companies will work with Non Governmental Organizations. What do you make of that?

DEE: Well, I think that the AIDS movement proves that the pharmaceutical companies can be forced into changing their ways. But, it’s absolutely a battle, from both sides. I think the fact that we were a disenfranchised population that knew how to get a little PR and how to call our Congress people and knew how to make some noise [made] a huge difference.

CHW: So you don’t see a rosy future where the industry changes?

DEE: I see a future where they know they have to deal with us, and we’re part of the landscape now. Like I said, the drug industry wouldn’t think of doing something without inviting the community. I just wish that our government would be as receptive. The FDA [was] not what it is today; they are a lot less willing to work with people, and [to] think about new ways of doing things. Under Clinton they were great. But this [the Bush] Administration has been unbelievable. Had it been another Administration in power, we could have had a much more welcome audience. I mean, it’s a very precarious situation we find ourselves in with Big Pharma. Nowhere else in the world do they get away with this. Their prices are fixed everywhere else in the world but here.

And it’s just really unconscionable what they get away with. You know, I’m not sure that if Clinton had been President we could have gotten that petition for margin rights. I’m not sure what Administration would change that.

CHW: Do you find the work harder or easier than you used to?

DEE: I think it’s much easier. What’s harder now is that a lot of the old people are doing different things and there are a lot of new people and it’s just awfully hard to listen to some of old issues come up over and over again. But it’s easier to deal with the companies and it’s easier to deal with the government now. We’re just part of the fabric of things now. They wouldn’t think of having a forum without involving the affected community.

CHW: So, what’s next for the Drug Development Committee?

DEE: Well, we’re very excited about integrase inhibitors. Merck [has] been a pleasure to deal with. The issues around Vioxx are unfortunate for them because they’ve always been one of the most progressive companies. They’re known among the investigators as the “Prince of Drug Companies” because, when they develop a drug, they spend a lot of money on research and a great development program. They keep records of side effects in patients for years and years.

We’ve also been working with the Senate with regard to FDA reform, and I’m the ATAC person for that. We’re looking forward to changing paradigms, as always, and, as far as drug development, the way protocols are designed, the way they’re approved, and the authority the FDA has over some of these companies. So that’s what I’m doing.

CHW: Thank you. I appreciate your talking to me.

DEE: You’re welcome. I appreciate your looking into this. I’m sure that it will help somewhere.

Courts and Congress Limit Rights of Local Government to Control Handguns

On March 9, 2007, the US Court of Appeals for the District of Columbia overturned that city’s longstanding handgun ban, issuing a decisionthat will allow the city’s citizens to have working firearms in their homes. In a 2-1 decision, the judges ruled that the activities protected by the Second Amendment “are not limited to militia service, nor is an individual’s enjoyment of the right contingent upon his or her continued intermittent enrollment in the militia”, setting the stage for a Supreme Court review since other federal courts have ruled differently. If the appeal does go to the high court, it would be the Supreme’s first case in nearly 70 years to address the Second Amendment’s scope. Washington Mayor Adrian Fenty has announced that the District will appeal the ruling, vowing, “We intend to do everything in our power to work to get this decision overturned, and in the meantime, we will vigorously enforce our handgun law.

In response to the court ruling, Paul Helmke, President of the Brady Center to Prevent Gun Violence, observed that “by disregarding nearly seventy years of U.S. Supreme Court precedent, two Federal judges have negated the democratically-expressed will of the people of the District of Columbia and deprived this community of a gun law it enacted thirty years ago and still strongly supports.” The NRA, on the other hand, applauded the decision, claiming that the “D.C. gun ban is a failure that costs innocent lives.”The court decision removed, at least for the time being, the right of municipal governments to ban handguns, further restricting the ability of local governments to regulate the gun industry. In 2005, Congress passed and President Bush signed the Protection of Lawful Commerce in Firearms Act, a bill that prohibits civil liability actions from being brought or continued against manufacturers, distributors, dealers, or importers of firearms or ammunition for damages, injunctive or other relief resulting from the misuse of their products by others. Several municipal governments had sued the gun industry for its negligent oversight of the retail distribution of handguns. The new law blocks Mayors from using courts to require the gun industry to absorb the costs of its products.

And in the Senate, pro-gun legislators looked to enact federal legislation that would further limit Washington, D.C.’s scope. Inspired by the Court of Appeals victory, and with the support of the National Rifle Association, Senator Kay Bailey Hutchison, R-Texas, announced she would reintroduce a piece of legislation aimed at making handguns legal in the District, a measure that previously passed in the House, but failed in the Senate.

New study shows benefits of local action

Even as the federal government acted on several fronts to restrict the ability of local governments to control handguns, a recent study from Milwaukee, Wisconsin shows the public health benefits of local action. In an article in the September 2006 Journal of Urban Health, researchers from the Center for Gun Policy and Research at the Johns Hopkins School of Public Health assessed the consequences of a decision by a gun store in Milwaukee to stop advertising Saturday night specials, cheap handguns frequently used in crimes. Prior to May 1999, a single gun store sold more than half of the guns recovered from criminals in Milwaukee. On May 10, 1999, the store decided to stop selling small, inexpensive handguns popular with criminals. According to the authors, over the next year, the “changed sales policy was associated with a 96% decrease in recently sold, small, inexpensive handguns used in crime in Milwaukee, a 73% decrease in crime guns recently sold by this dealer, and a 44% decrease in the flow of all new, trafficked guns to criminals in Milwaukee.”

The Marin Institute Takes On Big Alcohol and Wins!

In September 2006, San Francisco’s Bay Area Rapid Transit District (BART) board of directors voted to reverse their previous decision prohibiting alcohol advertising on BART buses and trains. Following this announcement, alcohol industry watchdog, The Marin Institute, took quick action and launched a campaign to get BART to reinstate the ban. The Marin Institute noted that while BART officials pointed to the increased revenues that would be associated with the alcohol ads, they neglected to mention that allowing such ads would further expose young people to alcohol industry marketing.

Two recent studies have noted that alcohol industry advertising has a strong effect on youth and contributes to underage drinking. In January of 2006, the American Medical Association’s Archives of Pediatrics and Adolescent Medicine published a study by Snyder et al which found that the number of alcohol ads viewed was positively associated with the amount of alcohol consumed by youth. Each advertisement viewed raised the number of drinks consumed by 1%.

In December of 2006, the American Academy of Pediatrics (AAP) released a statement expressing serious concern about the effects of corporate marketing on youth. The AAP noted that youth view an estimated 40,000 advertisements per year and that exposure to advertising from the food, beverage, tobacco, and alcohol industries may significantly contribute to obesity, poor nutrition, alcohol, and tobacco use in young people. According to the AAP, youth spend an estimated $180 billion per year and influence an additional $200 billion of their parents’ spending per year. As a result, advertisers consider young people to be an important market and seek new and creative ways to reach them. With regard to alcohol, the AAP argued that with $5.7 billion spent per year on advertising and promotion, and an estimated 2,000 beer and wine commercials viewed annually, exposure to alcohol industry advertising “represents a significant risk factor” for youth. Referring to the fact that minority neighborhoods have five times the number of alcohol billboards as do white neighborhoods, the AAP further noted that youth of color may be particularly at risk.

Pointing to the risks for youth associated with alcohol industry marketing, on December 7, 2006 the Marin Institute and Bay Area community leaders came out to oppose BART’s decision. Because of the strength of their coalition and the size of their turnout, the BART board of directors reversed its decision to allow alcohol advertising on Bay Area buses and trains.

After their victory with BART, the Marin Institute continued to address outdoor alcohol advertising in San Francisco. In January of this year, the organization issued a report stating that CBS Outdoor, the nation’s largest outdoor advertiser and owner of outdoor advertising space in San Francisco, had blatantly disregarded voluntary alcohol advertising codes as well as its contract with the City’s Municipal Transportation Agency (MUNI) by placing alcohol advertisements near schools. The Marin Institute surveyed three of San Francisco’s school districts and found 15 alcohol ads on public transit shelters. Ads were also found near playgrounds and churches.

The Marin Institute stated in the report, “Extrapolating to the entire city (all 11 districts), we conservatively estimate that at least 55 ads are in direct violation of the CBS Outdoor and MTA contract. Furthermore, we conservatively estimate at least 81 violations of both contract and national standards city wide.”

The Marin Institute held a press conference calling on CBS Outdoor to immediately remove the ads and for the San Francisco Municipal Transportation Authority to enforce the terms of the contract. Shortly afterward, the offending ads were removed. In addition, MUNI pledged to disallow alcohol advertising in future contracts.

Between their successful BART and MUNI campaigns, the Marin Institute has managed to keep the Bay Area completely free of outdoor alcohol advertising on public transportation. Not only will their efforts significantly reduce the amount of such advertising youth are exposed to, but they demonstrate that community campaign pressure on public officials, advertisers, and corporations can lead to victories that protect public health.