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Context of '1990-2000: Clinical Research Studies Being Done Increasingly by Private Firms instead of Universities'

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During this period, pharmaceutical companies begin hiring fewer and fewer universities to perform the clinical research studies for their drugs, contracting instead private research firms or conducting the studies themselves. In the early 1990s, roughly 75 percent of drug companies’ clinical research budgets went to universities. By 2000, this figure drops to only 34 percent. [New York Times, 11/22/2002]

Timeline Tags: US Health Care

A number of agricultural biotech firms secure patents on genetic use restriction technologies (GURTs). GURT, more commonly known as “terminator” technology, involves genetically engineering seeds to grow into sterile plants. The motivation behind this technology is to provide a means for seed companies to protect their intellectual property rights. By making their seeds genetically sterile, seed companies can prevent farmers from saving and replanting proprietary seeds, thus forcing farmers to purchase new seeds every year. Critics say that biotech companies intend to use the technology to force their seeds on Third World farmers, most of whom engage in subsistence-level farming and plant only common seed. The seed industry sees these farmers as a huge untapped market. Seed savers number an estimated 1.4 billion farmers worldwide—100 million in Latin America, 300 million in Africa, and 1 billion in Asia—and are responsible for growing between 15 and 20 percent of the world’s food supply. [USPTO Patent Database, 3/3/1998; Rural Advancement Foundation International, 3/30/1998; Ecologist, 9/1998] In addition to GURT, companies are seeking to develop a similar technology, called T-GURT or genetic trait control. This technology would make plant growth or the expression of certain genes contingent on whether or not the seed or plant is exposed to certain chemicals. For example, AstraZeneca is developing a technology to produce crops that would fail to grow properly if they are not regularly exposed to the company’s chemicals. The Canadian-based Rural Advancement Foundation International (RAFI) suggests that T-GURT could serve as a platform upon which certain proprietary traits could be placed. In order to turn positive traits (e.g., herbicide-resistance) on, or negative traits (e.g., sterility) off, the farmer would need to either apply proprietary chemicals to the crops as they grow or pay to have the seeds soaked in a catalyst solution prior to planting. Critics note that this technology, like terminator technology, would require that farmers pay every year to have functioning seeds. Farmers would, in effect, be leasing the seed. Companies developing GURT and T-GURT seeds include Novartis, AstraZeneca, Monsanto, Pioneer Hi-Bred, Rhone Poulenc, and DuPont. [Rural Advancement Foundation International, 1/27/1999; Rural Advancement Foundation International, 1/30/1999; Rural Advancement Foundation International, 1/30/1999]
Critics Say: -
bullet Terminator seeds would either turn poor farmers into “bioserfs,” by requiring them to pay for their seed every year, or drive these farmers out of farming all together. Proponents counter that farmers would not be forced to buy the seed. [Rural Advancement Foundation International, 3/30/1998]
bullet If biotech seed companies were to penetrate the markets of non-industrialized countries, their seeds would replace thousands of locally grown and adapted varieties resulting in a significant loss of the world’s agricultural biodiversity. [Rural Advancement Foundation International, 3/30/1998]
bullet The use of terminator technology would allow the seed industry to expand into new sectors of the seed market, like those for self-pollinating crops such as wheat, rice, cotton, soybeans, oats and sorghum, according to the Canadian-based Rural Advancement Foundation International (RAFI). “Historically there has been little commercial interest in non-hybridized seeds such as wheat and rice because there was no way for seed companies to control reproduction. With the patent announcement, the world’s two most critical food crops—rice and wheat—staple crops for three-quarters of the world’s poor, potentially enter the realm of private monopoly.” The organization notes that according to FAO, wheat, the world’s most widely cultivated crop, was grown on 219 million hectares in 1995. Rice, which was cultivated on 149 million hectares that year, produced the most crop by weight at 542 million tons. [Rural Advancement Foundation International, 3/30/1998]
bullet Critics warn that terminator technology would threaten the farmers’ expertise in seed selection and traditional plant breeding. [India, 12/2/1998]
bullet Some scientists have warned that introducing terminator genes into the germplasm could result in the development of a virus that could disable all non-terminator seeds. “This is perfectly possible,” according to Dr. Owain Williams, of the Gaia Foundation. “Already bacteria have been developed for fixing nitrogen into corn roots, so why not a killer bacteria?” [Independent, 3/22/1998]
bullet Terminator technology is also likened to piracy. Anuradha Mittal and Peter Rosset of Food First/The Institute for Food and Development Policy, write: “Patenting genes the same way you patent software robs Third World farmers. While they and their ancestors developed almost all important food crops, transnational corporations can now blithely patent those crops and make mega profits without in any way compensating traditional farm communities for the original research. Genetic resources taken freely from southern countries will be returned to them later as pricey patented commodities. ‘Terminator’ technology is a way of locking this ‘bio-piracy’ into the very genes themselves.” [San Francisco Chronicle, 3/1/1999]
Proponents Say: -
bullet Supporters of the technology say that farmers will not be required to buy the seed and therefore will not purchase it unless they perceive some benefit from using it. Critics say that this scenario is not realistic. In a market dominated by an ever diminishing number of seed companies, selection will be limited. RAFI notes: “Current trends in seed industry consolidation, coupled with rapid declines in public sector breeding, mean that farmers are increasingly vulnerable and have far fewer options in the marketplace.” [Rural Advancement Foundation International, 3/30/1998]
bullet Some proponents argue that terminator seeds would be no different than F1 hybrids, which produce lower quality seeds than their parents. [London Times, 11/4/1998]
bullet Advocates say that terminator technology will allow the industry to safely release genetically modified plants into the environment, without the risk of contaminating related crops or wild plants. [New Scientist, 2/26/2005] Critics say that alleged benefit is outweighed by the danger terminator seeds pose to food safety, farmers’ rights, and agricultural biodiversity. [Rural Advancement Foundation International, 3/30/1998]

Timeline Tags: Seeds, Food Safety

Research done by Dr. Garrett FitzGerald suggests that COX-2 inhibiting drugs, like Vioxx and Celebrex, increase the risk of cardiovascular problems. FitzGerald believes that COX-2 inhibitors block the production of a substance called prostacyclin, which leads to blood vessel constriction and clotting. His research is dismissed by Merck, the maker of Vioxx. Vioxx’s only selling point is that it causes fewer gastrointestinal problems than other pain killers on the market. But according to FitzGerald, the mechanism that makes the drug gentler on the stomach is also responsible for causing the cardiovascular problems. [MSNBC, 10/6/2004] FitzGerald’s research is later published in two studies, one in 1999 and another in 2001. [Associated Press, 6/22/2005]

Entity Tags: Merck, Garrett FitzGerald

Timeline Tags: US Health Care

Omnicom, one of the world’s largest advertising firms, pays $20 million for part-ownership of Scirex, a research firm that conducts clinical studies on drugs to determine their effectiveness and safety. Thomas L. Harrison, a top executive of the company, says he expects Scirex’s studies to provide positive results for its clients in the drug industry. “Our goal is to help ensure that all clinical studies and each patient accrued into a study can be assessed to support the NDA submission.” [New York Times, 11/22/2002]

Entity Tags: Omnicom, Scirex, Thomas L. Harrison

Timeline Tags: US Health Care

According to an internal company document, Merck research chief Edward Scolnick discusses possible plans to reformulate Vioxx with the company’s in-house patent counsel. The new Vioxx would contain an anti-clotting agent to reduce the risk of cardiovascular problems. The document indicates that the company’s researchers believe the current Vioxx formula inhibits the production of a substance called prostacyclin which leads to blood vessel constriction and clotting. But Merck was alerted to this problem two years before by scientist Garrett FitzGerald, who had warned the company that all Cox-2 inhibitors would likely have this effect. Merck, eager to get its drug on the market, dismissed his research (see 1998). [Associated Press, 6/22/2005]

Entity Tags: Edward Scolnick, Merck

Timeline Tags: US Health Care

An expert panel convened by the National Science Academy’s Institute of Medicine issues a report recommending a number of changes to how the FDA regulates the drug industry. The proposed changes are unanimously endorsed by the panel, comprised of 15 experts from academic and professional organizations. Some of the recommendations include:
bullet The FDA should implement a moratorium on direct consumer advertising of recently approved classes of drugs until enough aggregate data is available to confirm the drugs’ safety. Packaging for such medications should have a special symbol imprinted on them alerting consumers to the higher risk associated with new medications.
bullet The FDA should be required to reevaluate the safety and effectiveness of drugs at least once every five years after the drug has been approved. The agency’s current system for monitoring drug safety post-approval is far less effective than pre-approval testing. The report notes that there is a history of fierce disagreements between the FDA’s Office of Drug Safety and the agency’s Office of New Drugs.
bullet The FDA should be given new powers to impose fines, injunctions, and withdrawals when drug companies fail to complete the required safety studies.
bullet The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe.
bullet The government should require drug companies to register all clinical trials they sponsor in a government-run database so patients and physicians can review all studies. Currently, only those studies published in medical journals are accessible to the public, and these tend to be the studies that produce the most favorable results for the drug being tested.
bullet Expert advisory panels should not be loaded with industry-connected scientists. Most of the members making up these panels should be free of industry ties. “FDA’s credibility is its most crucial asset, and recent concerns about the independence of advisory committee members… have cast a shadow on the trustworthiness of the scientific advice received by the agency,” the report says. [Institute of Medicine, 9/22/2006; Washington Post, 9/23/2006; New York Times, 9/23/2006]

Entity Tags: US Food and Drug Administration, Institute of Medicine

Timeline Tags: US Health Care

The Bush administration decides to drop its plan to nominate Dr. Alastair J. J. Wood as commissioner of the Food and Drug Administration. An article recently posted on the conservative National Review Online’s website warned that Wood is not friendly to industry interests. “The people I know in clinical pharmacology, in the research trenches, went berserk when they heard about Wood,” wrote Robert Goldberg, a senior fellow at New York’s Manhattan Institute, a free-market think tank. Goldberg said the doctor is overly obsessed with drug safety and asserts, falsely, that Wood is “a buddy of Senator Ted Kennedy.” The attack on Wood was continued in the editorial pages of the Wall Street Journal six days later in a piece titled “It’s Not Ted’s FDA.” Shortly after the publication of these articles, the White House calls Wood to inform him that the administration is no longer considering his nomination for commissioner, a post that has been vacant for more than a year. Republican Senator Bill Frist—the person who had recommended Wood’s nomination—tells the Boston Globe that the White House was concerned that Wood “put too much emphasis on the safety.” Wood’s track record was evidence that he might take an aggressive approach to regulating drugs. He previously called for an independent board to investigate potentially deadly drugs. The current policy is to allow the drug companies to do their own studies on adverse drug reactions and then provide these results to the FDA. Wood has also said that he believes the current FDA regulatory process has an inherent conflict of interest because the same department that approves drugs is also in charge of reviewing the safety of those drugs post-approval, a criticism that is shared by at least one FDA insider (see November 18, 2004). Furthermore, in May 2001, Wood supported making three allergy prescription drugs—Pfizer’s Zyrtec, Schering-Plough’s Claritin, and Aventis’s Allegra—available over-the-counter (OTC). The companies were opposed to the idea because OTC drugs are often sold at lower prices and are not typically covered by insurance. During a panel discussion on the issue, Wood had noted, “What we have today is an unseemly parade of people trying to protect their own financial interests.” [Boston Globe, 5/27/2002]

Entity Tags: Robert Goldberg, Bush administration (43), Alastair J. J. Wood

Timeline Tags: US Health Care

The Journal of the American Dental Association publishes a study concluding that Bextra, a new drug manufactured by Pharmacia, offers relief to the acute pain patients feel after dental surgery. [Daniels et al., 2002] Just six months before, the FDA investigated the claim and found no evidence to support it. [New York Times, 11/22/2002] Bextra is only approved to treat pain caused by arthritis or painful menstrual cycles. [US Food and Drug Administration, 11/22/2002] During the three-month period following the article’s publication, Bextra sales increase by 60 percent. It is later learned that the authors of the article were not independent scientists, but rather employees of Scirex, a research company owned partially by Omnicom, one of the world’s largest advertising firms. When the New York Times asks three doctors to review the Scirex article, the doctors say its conclusions are not persuasive. “All three said that one of Scirex’s conclusions was insignificant: that one dose of Bextra worked longer than a single dose of a medicine containing oxycodone and acetaminophen, a combination often sold under the brand name Percocet. Patients rarely receive just one dose of that combination drug, the doctors said, because it wears off in four to six hours.” One of the doctors, Eric J. Topol, says the studies cited in the article make “a contrived comparison.” He notes that patients in the study had an average age of 23, which is not representative of the age group that would mostly likely use the drug. Judy Glova, a spokeswoman for Pharmacia, denies in a statement to the New York Times, that the article was an attempt to bypass the FDA regulation. And Pat Sloan of Omnicom insists the company has “nothing to do with the design of clinical studies.” [New York Times, 11/22/2002]

Entity Tags: Pharmacia & Upjohn Inc, Eric Topol, Omnicom, Scirex

Timeline Tags: US Health Care

The Environmental Protection Agency (EPA) meets its February 27, 2004 deadline to come up with a new federal rule regulating formaldehyde emissions. Ignoring the opinion of experts, the EPA did not take into account the findings of two recent studies (see November 2003) (see Early 2004) that had found that workers who were exposed to formaldehyde were at an elevated risk of leukemia. The EPA said it did not have time to incorporate the two findings before the deadline. Though extensions for such deadlines are often given, the agency did not request one. Instead, the EPA relied on a cancer risk assessment by the Chemical Industry Institute of Toxicology, a private, nonprofit research organization, funded primarily by chemical companies. That assessment was about 10,000 times weaker than the level previously used by the EPA in setting standards for formaldehyde exposure. The new federal rule is modeled on a proposal that had been designed by a lobbyist for the wood products industry (see January 14, 2002). It creates a new category of “low-risk” plants, which gives the agency the authority to decide on a plant-by-plant basis which facilities pose a risk to public health. It initially exempts eight wood products plants from having to install pollution controls for formaldehyde and other emissions, but could eventually extend the exemptions to 147 or more of the 223 facilities nationwide. The exemption allows qualifying plants to legally skirt pollution-control requirements that had been mandated by a 1990 amendment to the Clean Air Act requiring all large industrial plants to use “best available” technology in order to reduce emissions of 189 substances. Though backers of the new rule claim that it does not violate the amendment, the lawmakers who wrote the legislation disagree. “I don’t have any doubt but that is a way to get around the policy which we worked hard to achieve,” former Sen. David F. Durenberger (R-Minn.) will tell the Los Angeles Times in May. Rep. Henry A. Waxman (D-Los Angeles) similarly says the exemption is “directly contrary to our intent.” The new rule will save the industry as much as $66 million annually for about 10 years in potential emission control costs. [Los Angeles Times, 5/21/2004]

Entity Tags: Bush administration (43), David F. Durenberger, Environmental Protection Agency, Henry A. Waxman

Timeline Tags: US Environmental Record

FDA scientist David Graham has analyzed data on 1.4 million Kaiser Permanente patients who took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. Based on his findings, Graham believes there have been more than 27,000 heart attacks and sudden cardiac deaths in the US that would not have occurred had those patients been prescribed Celebrex instead of Vioxx. [Washington Post, 10/8/2004] When the FDA reviews a summary of his study, which Graham will present in France on August 25 (see August 25, 2004), his conclusion triggers “an explosive response from the Office of New Drugs.” Graham later tells Congress, “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.” [US Congress, 11/18/2004 pdf file] In an August 12 e-mail, John Jenkins, director of the Office of New Drugs, suggests “watering down” the report’s conclusions because the FDA is “not contemplating” a warning against high-doses of Vioxx. In response, Graham says, “I’ve gone about as far as I can without compromising my deeply-held conclusions about this safety question.” In another e-mail, a different top official expresses concern about how the report might impact Merck. The person writes that the company should be warned beforehand “so they can be prepared for [the] extensive media attention that this will likely provoke.” [Wall Street Journal, 10/8/2004; Washington Post, 10/8/2004]

Entity Tags: John Jenkins, David Graham

Timeline Tags: US Health Care

David Graham, associate science director for the FDA’s Office of Drug Safety, presents the findings of a study on Vioxx in a poster exhibit at an international medical conference in Bordeaux, France. According to Graham’s research, thousands of Americans have died from taking the drug. In his study, he analyzed data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. According to Graham’s analysis of the data, the risk of having a heart attack or dying from heart problems is 3.2 times higher for Vioxx patients than people who do not use painkillers, and twice as high for those using Celebrex. Based on these figures, Graham estimates that more than 27,000 Americans have had heart attacks or died from sudden cardiac deaths as a result of taking Vioxx instead of Celebrex. In response to Graham’s study, Merck, the maker of Vioxx, issues a statement insisting that its drug is safe. Alise Reicin, vice president of clinical research at Merck, claims that numerous studies comparing the drug to a dummy pill found “no difference in the risk of having a serious cardiovascular event.” FDA spokeswoman Laura Alvey says the FDA has no plans to ban the drug. “Removing the drug from the market is not on the table,” she says. [Associated Press, 8/26/2004] Prior to the event, FDA officials had pressured him to water down his conclusions (see Mid-August 2004).

Entity Tags: Laura Alvey, Alise Reicin, David Graham, Merck

Timeline Tags: US Health Care

Merck voluntarily withdraws Vioxx from the market after a long term colon-polyp prevention study, called APPROVe, appears to show that the drug doubles the risk of heart attacks or strokes when taken for 18 months or longer. [Merck, 9/30/2004 pdf file] Acting FDA Commissioner Dr. Lester M. Crawford praises Merck for “promptly reporting these finding” to the FDA. [US Food and Drug Administration, 9/30/2004] An estimated 107 million people have used Vioxx since it was approved in 1998. A paper by FDA scientist David Graham, published in the British medical journal Lancet, will later suggest that 88,000-140,000 Americans may have suffered serious coronary heart disease as a result of taking the drug. (see January 25, 2005)

Entity Tags: Lester M. Crawford

Timeline Tags: US Health Care

David Graham, associate science director for the FDA’s Office of Drug Safety, appears before the Senate Committee on Finance to testify on the agency’s ability to protect the American public from harmful drugs. Graham, a twenty-year veteran of the agency, tells the committee that “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” Graham was an early critic of Vioxx, a painkiller that was recalled in September (see September 30, 2004) because of its link to heart problems. Graham recounts how in August (see Mid-August 2004), the FDA tried to suppress a study he led which found that “nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.” He says the study’s findings were “extremely conservative” and that “a more realistic and likely… estimate ranges from 88,000 to 139,000 Americans” of which “30-40 percent [or 26,400-55,600] probably died.” He notes that this figure is the “rough equivalent of 500 to 900 aircraft dropping from the sky… [or] 2-4 aircraft every week, week in and week out, for the past 5 years.” [US Congress, 11/18/2004 pdf file] The remainder of Graham’s testimony focuses on problems within the FDA’s Office of Drug Safety (ODS). He makes the following points:
bullet The Office of New Drugs (ONS), which approves all new drugs, is the same division that is responsible for taking regulatory action against those drugs after they have been released on the market. This is an inherent conflict of interest, he notes, because when a problem arises, recognizing it would require the ONS to acknowledge that it had made a mistake. Instead, the office’s “immediate reaction [to a problem] is almost always one of denial, rejection, and heat.” [US Congress, 11/18/2004 pdf file]
bullet The Office of Drug Safety (ODS) is subordinate to the Office of New Drugs, and consequently the management of the former sees its mission as pleasing the latter. [US Congress, 11/18/2004 pdf file]
bullet The culture of the FDA’s Center for Drug Evaluation and Research (CDER) “views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards, and disrespects drug safety.” [US Congress, 11/18/2004 pdf file]
bullet The Office of New Drugs refuses to take regulatory action on any drug unless it can be shown with 95 percent or greater certainty that it is unsafe. However “to demonstrate a safety problem with 95 percent certainty, extremely large studies are often needed… [and] those large studies cannot be done.” Graham suggests the 95 percent rule makes as much sense as a person with a 100-chamber pistol loaded with 90 bullets saying that the gun is safe. “Because there is only a 90 percent chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.” [US Congress, 11/18/2004 pdf file]

Entity Tags: David Graham

Timeline Tags: US Health Care

The British medical journal Lancet publishes a paper by FDA scientist David Graham suggesting that tens of thousands of Americans probably died from taking Vioxx, a painkiller that was recalled in September (see September 30, 2004). His study looked at data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. The data showed that the risk of having a heart attack or dying from heart problems was 1.6 times higher for patients taking standard-dose Vioxx compared with those using Celebrex. The risk was 3.6 times higher for those on high doses. Graham notes that Vioxx’s potential impact on the patient population was likely severe. Using the risk factors from Merck-sponsored randomized clinical trials, and extrapolating these to the estimated 106.7 million Vioxx patients, Graham says that the drug may have caused cardiovascular problems for 88,000-140,000 Americans. It is estimated that 44 percent of acute myocardial infarction’s are fatal. [Graham et al., 2005 pdf file; London Times, 1/25/2005] In November, Graham told Congress that senior managers at the FDA’s Office of Drug Safety had delayed giving Graham permission to publish this study, even after it had been accepted by Lancet. [US Congress, 11/18/2004 pdf file]

Entity Tags: David Graham

Timeline Tags: US Health Care

An expert panel convened by the US Food and Drug Administration unanimously agrees that Celebrex, Bextra, and Vioxx “significantly increase the risk of cardiovascular events” such as heart attacks. However the panel does not believe that the risk is so great that these drugs should be banned from the market. (Vioxx was withdrawn from the market voluntarily by its manufacturer in September (see September 30, 2004).) The sales of these drugs should be permitted to continue, but only under strict conditions, the panel says. It also recommends a prohibition on direct marketing to consumers, a patient’s guide for the drug, and a black box warning—the most severe possible—detailing the drug’s cardiovascular side effects. [CNN, 2/18/2005; Washington Times, 2/19/2005] After the vote, the New York Times reveals that 10 of the panel’s 32 members had at one time been paid-consultants to the makers of the drugs in question. In analyzing the votes, the Times discovers that neither Bextra nor Vioxx would have survived the vote if the scientists with connections to the company had not voted. For both Bextra and Vioxx, the industry-connected panelists voted 9 to 1 in favor, while the experts with no ties voted 14 to 8 and 17 to 15 to ban Bextra and Vioxx, respectively. The Times notes in its article that “these votes were deeply important” for the makers of those drugs. After the votes, the shares of Merck and Pfizer increase substantially. In e-mails to the Times, eight of the panelists, responding to questions from the newspaper, say their votes were not influenced by their ties to the companies. Two of the panelists do not respond. One of the panel members, Dr. John Farrar, who has received research support from Pfizer, says, “I think FDA would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company.” But another panel member, Dr. Curt Furberg, who has no ties, says he was “uncomfortable with the Pfizer-friendly undertone” at the meeting and he felt the industry ties might have contributed to that tone. Furberg adds that it has never been proven that Celebrex, Bextra, or Vioxx offer better pain relief than ibuprofen or more than a dozen other over-the-counter drugs. Daniel E. Troy, the FDA’s former chief counsel and a longtime advocate of drug-maker interests, plays down the importance of the ties, saying that any suggestion that experts’ votes were influenced by industry connections “buys into an overly conspiratorial view of the world.” [New York Times, 2/25/2005]

Entity Tags: Daniel E. Troy, John Farrar, Curt Furberg, US Food and Drug Administration

Timeline Tags: US Health Care

Dr. Susan Molchan testifies before Congress.Dr. Susan Molchan testifies before Congress. [Source: CBS News]Dr. Susan Molchan, a former clinical researcher for the National Institutes of Health (NIH), testifies before Congress that her supervisor at NIH made a secret deal with the pharmaceutical company Pfizer that involved human tissue samples supposedly collected for the public good, but were instead used for Pfizer’s own research and garnered the company millions in profit. [CBS News, 6/14/2006] Molchan testifies before the House Energy and Commerce Subcommittee on Oversight and Investigations [The Scientist, 6/14/2006] that a collection of unused spinal fluid samples, which CBS News describes as a "a treasure trove of biological material, many painfully given up by Alzheimer’s patients" disappeared without a trace from her laboratory freezer at NIH. The samples were slated to be used for NIH studies on Alzheimer’s disease. Molchan says she was told that some of the samples were lost due to freezer malfunctions, but, "nothing solid, nothing that made sense. I never got a handle on what happened to them." [CBS News, 6/14/2006] Procuring the tissue samples alone cost the government $6.4 million, say committee staffers, who spent a year investigating the matter. "It would really be a shame if we find out that the National Institutes of Health has more control over its paper clips and trash cans than it has over its human tissue samples," says committee member Joe Barton (R-TX). [The Scientist, 6/14/2006] Molchan’s testimony, and other data gathered by Congressional investigators, prove that Molchan’s immediate supervisor, Dr. Trey Sunderland, a well-known psychiatric researcher, cut a secret deal with Pfizer at the same time Pfizer was launching and refining a new Alzheimer’s drug. "If individual scientists are making use of that tissue for their own personal gain, that’s something we need to know about it. It’s not the right thing," says House Energy subcommittee chairman Ed Whitfield (R-KY). Sunderland provided Pfizer "access" to 3,200 tubes of spinal fluid, costing the NIH and, as a result, taxpayers, an estimated $6 million. In exchange, Sunderland reportedly received $285,000 in personal compensation. Pfizer’s drug Aricept is now the top-selling drug in the world for treating Alzheimer’s, generating $1.6 billion in sales in 2004. "The more tissue samples you can collect these days and extract genetic information about risk and benefit, that’s the future of drug development around the world," says Dr. Art Caplan, a bio-ethicist at the University of Pennsylvania. The House committee finds that Pfizer itself broke no NIH rules or knew of any wrongdoing by Sunderland, who does not testify before Congress, instead invoking his Fifth Amendment right against self-incrimination. [CBS News, 6/14/2006] Sunderland himself received more than $600,000 in outside consulting and speaking fees from Pfizer from 1998 to 2004 without prior government disclosure or approval. A review by NIH’s Office of Management Assessment found that Sunderland "engaged in serious misconduct, in violation of HHS ethics rules and Federal law and regulation," the report stated. In December 2006, Sunderland will accept a plea bargain in regards to his accepting payments from Pfizer (see December 11, 2006). [The Scientist, 6/14/2006]

Entity Tags: Susan Molcher, Pfizer, Joe Barton, Pearson (“Trey”) Sunderland III, Art Capland, Ed Whitfield, United States National Institutes of Health

Timeline Tags: US Health Care

In a 93-1 vote, the US Senate passes the Food and Drug Administration Improvement Act of 2007 (H.R.2273), which grants the FDA broad new authority to monitor the safety of drugs after they are approved. It was based in part on the recommendations of a 2001 report by the Institute of Medicine (see September 22, 2001). The institute had been asked by the FDA to examine drug safety after it was revealed that the FDA and drugmaker Merck had permitted the drug Vioxx to stay on the market despite numerous indications that it increased patients’ risk of a heart attack. But the bill that is passed is much weaker than the original version, and ignores some of the institute’s most critical recommendations. A USA Today investigation will find that industry-friendly changes made to the bill were instigated by senators “who raised millions of dollars in campaign donations from pharmaceutical interests.” For example, 49 senators successfully defeated an effort that would have allowed US consumers to import lower-cost drugs from Canada and other industrialized countries. The senators who opposed the provision “received about $5 million from industry executives and political action committees since 2001—nearly three quarters of the industry donations to current members of the Senate,” USA Today found. Another factor contributing to the amendment’s failure was that President Bush said he would veto the bill if it permitted the imports. Also excised from the bill was language that would have give the FDA the authority to ban advertising of high-risk drugs for two years. This was one of the Institute of Medicine’s key recommendations. Senator Pat Roberts (R-Kan) argued that the change would restrict free speech. Drug interests have given Roberts $18,000 so far this year, and $66,000 since 2001. Sen. Judd Gregg (R-NH) was responsible for a change that reduced the agency’s power to require post-market safety studies. He insisted on limiting this authority so that the FDA could only target drugs when there’s evidence of harm. Gregg has received $168,500 from drug industry interests since 2001. The bill’s main sponsors—senators Edward Kennedy, (D-Mass) and Mike Enzi (R-Wyo)—agreed to water down a proposal that would have required all clinical drug studies be made public after meeting with industry officials. The senators agreed to change the language so that only studies submitted to the FDA would be available. Enzi and Kennedy have received $174,000 and $78,000, respectively, from drug interests since 2001. Amendments aimed at reducing industry conflicts of interest on FDA expert advisory panels were also stripped from the bill. One of those amendments would have made it more difficult for scientists to advise the FDA on drug approval applications from a company the scientist had received money from. Another would have required that FDA panels consist of no more than one member with financial ties to the drug industry. The Senate also rejected an amendment to establish an independent FDA office to monitor the safety of drugs after they are released on the market. The office that currently has this authority is the same one that approves new drugs, an arrangement that lawmakers and at least one FDA scientist (see November 18, 2004) believe is a conflict of interest. [WebMD Medical News, 5/9/2007; US Congress, 5/10/2007; USA Today, 5/14/2007]

Entity Tags: George W. Bush, Edward M. (“Ted”) Kennedy, Judd Gregg, Mike Enzi, US Food and Drug Administration, Pat Roberts

Timeline Tags: US Health Care

Former health insurance executive Wendell Potter (see July 10, 2009), who formerly headed the PR division at Cigna, says that the skyrocketing profits of health care corporations and their executives are directly driving the industry’s opposition to health care reform. According to filings with the Securities and Exchange Commission, the profits of the US’s 10 largest health insurance companies rose 428 percent between 2000 and 2007. In 2000, those 10 companies made a combined profit of $2.4 billion. In 2007, those numbers had risen to $12.9 billion. During that seven-year period, the number of Americans without health insurance rose 19 percent. The CEOs of those 10 firms made an average of $11.9 million in 2007 alone. MSNBC’s Rachel Maddow notes that the health insurance industry “bankrolled efforts to kill the last effort at health care reform” in 1994 (see Mid-January - February 4, 1994). In an interview with Maddow, Potter blames the insurance industry for much of the recent spate of “town hall” disruptions that have helped derail debate over health care reform (see June 30, 2009, July 6, 2009, July 25, 2009, July 27, 2009, July 27, 2009, July 31, 2009, August 1, 2009, August 1, 2009, August 2, 2009, August 3, 2009, August 3, 2009, August 3, 2009, August 3, 2009, August 4, 2009, August 4, 2009, August 5, 2009, August 5, 2009, August 6, 2009, August 6, 2009, August 6-8, 2009, August 8, 2009, and August 10, 2009) “and a lot of the deception that’s going on in terms of disinformation that many Americans apparently are believing.” Potter goes on to note that health insurance firms are making tremendous profits on the steady erosion of paid premiums going to fund medical claims. In 1993, the industry paid out roughly 95 percent of the premiums they took in to claims. In 2007, that number had dropped to 80 percent. Insurance firms also routinely “kick sick people off the rolls when they do get sick or when people get injured.… [A]nd also, they’re paying fewer claims.” The health insurance industry is dead set against the so-called “public option,” Potter says, for the simple reason that a publicly run alternative to private insurance would cost its members profits. [MSNBC, 8/11/2009]

Entity Tags: Wendell Potter, Rachel Maddow

Timeline Tags: US Health Care

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