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BERNARD FISHER SETTLES SUIT FOR $2.75M, RETAINS TITLE; UNIVERSITY APOLOGIZES |
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 Top Bernard Fisher Settles Suit... Immunex to Market Generic...Brain Stores Speech Function...President Clinton Deals Blow...The American Society of... |
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NCI, also a defendant in the civil action brought by Fisher, issued a statement that enumerated Fisher’s contributions to the understanding and treatment of breast cancer. "Through his role as the scientific leader of the National Surgical Adjuvant Breast and Bowel Project (NSABP), [Fisher] has not only changed the way breast cancer is treated, but enlightened medical science to view breast cancer as not just a tumor confined to the breast, but as a systemic disease requiring more than surgical intervention," NCI said in a statement. The Institute contributed $300,000 to the overall settlement, to cover a portion of Fisher’s legal expenses, sources said.
The settlement was reached August 27, 1997, six days before the case was scheduled to go to trial at the U.S. District Court for the Western District of Pennsylvania. Though all parties agreed not to discuss the terms of the settlement agreement, The Cancer Letter obtained a copy of the document under the Freedom of Information Act.
"I am glad to be alive to see this vindication," Fisher said to The Cancer Letter. "I feel that I am still in a position to continue to make contributions, and I want to go forward in the best way I can: to write, and to complete data that needs to be put out." Fisher declined to describe his plans for the future. "My plans are in the process of being formulated," said Fisher, who is 78. "At this time, I am scientific director of the NSABP, and I would like to continue in that mode, and to make whatever contributions that I can to the organization as it now exists." The scientific director’s post can have a significant impact on generating interest in clinical trials and development of protocols, sources said.
The settlement is likely to conclude the tangled controversy that began on March 13, 1994, when an article in the Chicago Tribune disclosed that Montreal surgeon Roger Poisson had contributed falsified data to NSABP clinical trials. Soon after the publication of the story, Fisher was removed from leadership of the cooperative group. The oversight and investigations subcommittee of the House Committee on Commerce conducted hearings on the matter, and the Health and Human Services Office of Research Integrity (ORI) was brought in to investigate possible misconduct by Fisher and two other officials at the cooperative group. Ultimately, the subcommittee, then headed by Rep. John Dingell (D-MI), accepted the mea culpa from NCI and the University of Pittsburgh and bowed out. Earlier this year, the ORI completed its investigation, finding no misconduct by Fisher and other NSABP officials.
In the just-settled suit, Fisher claimed that NCI officials had "unlawfully terminated" him as principal investigator of NSABP and "crafted multiple false accusations" against him. "In an effort to keep millions of federal research dollars flowing to the university," University of Pittsburgh officials assisted NCI in Fisher’s firing, Fisher’s attorneys stated in the most recent version of the complaint, filed in December, 1995.
The suit also named Martin Michaelson, an attorney with Hogan & Hartson, who was hired by the university to handle the matter in its initial stages. "Defendants Michaelson and Hogan & Hartson obtained Dr. Fisher’s confidences by representing that a privileged attorney-client relationship existed between them," but ultimately shared these privileged and confidential communications with the university, NCI, ORI, and the staff of the Subcommittee on Oversight and Investigations of the House Committee on Commerce, the complaint states.
Under the settlement agreement, Fisher is to receive a single check for $2.75 million, documents say. The check would be issued by the University of Pittsburgh "on behalf of all defense interests" within 45 days of the signing of the agreement.
While the federal government will contribute $300,000 toward the settlement, it is unspecified how much of the remaining $2.45 million would come from the University of Pittsburgh and how much (if anything) would come from Hogan & Hartson. Though Fisher will retain his title, he would collect neither a salary nor employee benefits. If he chooses to stay at the university, Fisher would be provided with office space, but no support staff. If he accepts a position elsewhere, he would receive no office space. Regardless of whether he stays or goes, Fisher would continue to have unrestricted access to NSABP data kept at the university, the agreement states.
In the document, federal defendants stated that all investigations surrounding Fisher have been concluded and that all previously imposed sanctions have been lifted. The text of that section of the memorandum follows:
"Dr. Fisher is not required to submit his manuscripts to the NCI prior to publication. [Any] requirement to that effect was rescinded April 10, 1995. Dr. Fisher is not precluded from participation in any federally funded cancer research project. A grant applicant, including any applicant for the Operations Center (based at Allegheny General Hospital in Pittsburgh) or Biostatistical Center (based at the University of Pittsburgh) NSABP grants, may list Dr. Fisher as a participant on an application, and any such application will be reviewed through the normal peer-review process. NCI will consider Dr. Fisher for a position on a top advisory committee at the NCI, taking into account his achievements and reputation. After a thorough investigation, the Office of Research Integrity did not make a finding of scientific misconduct." 
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IMMUNEX TO MARKET GENERIC PACLITAXEL IN CANADA |
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TopBernard Fisher Settles Suit...Immunex to Market Generic...Brain Stores Speech Function...President Clinton Deals Blow...The American Society of... |
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The branded paclitaxel is marketed as Taxol by Bristol-Myers Squibb (BMS) Company. The BMS market exclusivity, which is protected for five years under the Waxman-Hatch Act, will expire in December of this year. However, the company’s use patents for the drug could extend its market exclusivity in the U.S. and several other markets for years to come, industry analysts say.
Immunex estimates the sales of the BMS Taxol in Canada were approximately $14.5 million (U.S.) last year. Immunex is marketing the generic paclitaxel through an agreement with American Cyanamid Company, the American Home Products (AHP) subsidiary which produces the drug. AHP owns a majority shareholder position in Immunex, the companies said. Bulk paclitaxel is supplied by Hauser Inc., of Boulder, Colorado. In May, 1994, Hauser signed a 10-year exclusive contract with American Cyanamid to supply the product. American Cyanamid became a subsidiary of AHP in August of that year.
Paclitaxel, indicated for refractory breast and ovarian cancer, will be marketed in Canada as 5 ml single dose vials containing 30 mg of paclitaxel, the company said. Michael Kleinberg, vice president of professional services at Immunex, said the company is conducting U.S. clinical trials of the drug and plans to enter the U.S. market as well.
Hauser first produced paclitaxel under an NCI Master Agreement in 1988. The company produced the drug first for NCI, then as part of a supply agreement with BMS. BMS chose not to extend the agreement with Hauser when it expired in 1994. Hauser’s European partner, Yew Tree Pharmaceuticals, received Dutch approval in April to market its paclitaxel drug, Yewtaxan. Shortly after the approval of Yewtaxan, BMS sued Yew Tree and the Dutch regulatory authorities. BMS said the approval of Yew Tree’s New Drug Application infringed on BMS dosage and infusion method patents issued in March.
Last month, a judge in The Hague issued a summary judgment denying the BMS claims, and ordered the company to pay the cost of court proceedings for Yew Tree, Hauser, and 10 other defendants in the case. Yew Tree will be free to market Yewtaxan while the Dutch suit is in progress.
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BRAIN STORES SPEECH FUNCTION DIFFERENTLY BASED ON AGE OF ACQUISITION, STUDY FINDS; IMPLICATIONS FOR BILINGUAL PATIENTS |
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TopBernard Fisher Settles Suit...Immunex to Market Generic...Brain Stores Speech Function...President Clinton Deals Blow...The American Society of... |
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The researchers used functional magnetic resonance imaging (fMRI) to observe activity patterns within the brains of 12 bilingual subjects. Six of the subjects had learned two languages in early childhood, while the other six had learned a second language during their teens. Each subject was placed in the fMRI scanner, and asked to think silently about the previous day’s events, in each of their languages. The subjects were not asked to speak aloud, because this can cause small head movements which obscure fMRI readings. For those who acquired a second language as an adult, the fMRI scan registered activity in Broca’s area when the subject thought in a native language, but activity registered in a separate area of the brain when the subject thought in the second language. For those who became bilingual as toddlers, "native and second languages tend to be represented in common areas" of the Broca’s area, the researchers said. "A second language acquired during the teenage years, which is late in developmental life, is represented in the brain in a separate location from the native language," said Joy Hirsch, a professor of neuroscience at MSKCC and senior author of the study. "When both languages are learned at the same time early in life, they are represented in areas that have a considerable amount of overlap." This may be due to the malleability of an infant’s brain.
"Based on the results of the current study, we always ask our patients whether they speak more than one language," said Karl Kim, lead author of the study. "If they do, both languages need to be mapped to acquire a complete picture of language-sensitive areas of the brain."
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PRESIDENT CLINTON DEALS BLOW TO TOBACCO SETTLEMENT, BUT OPENS DOOR TO TOUGHER MEASURES |
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TopBernard Fisher Settles Suit...Immunex to Market Generic...Brain Stores Speech Function...President Clinton Deals Blow...The American Society of... |
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Though the pending deal between tobacco companies and the attorneys general of 40 states may have been dealt a fatal blow by the President, the debates over that deal may have given Congress the resolve to consider regulatory measures that would not require consent of the tobacco industry, Capitol Hill observers said. That could mean higher taxes on cigarettes, well-funded tobacco control measures, and, possibly, new money for cancer research.
The President’s guidelines addressed every issue that was raised by the American Cancer Society (ACS) following its review of the proposed agreement between the tobacco industry and the attorneys general, said John Seffrin, ACS chief executive officer. ACS played a key role in assessing the impact of the proposed agreement between the industry and the attorneys general and lobbying for a stronger tobacco control legislation. On July 24, 1997, a month after the language of the settlement proposal was released, ACS said it would not support the proposed agreement between the industry and the attorneys general, and produced a set of guidelines for reaching an acceptable deal. "The President’s statement today materially addresses all our principles in terms of the fatal flaws in the proposed settlement," Seffrin said to The Cancer Letter. "I would anticipate that there is a very good chance that the public health community will close ranks behind the Administration, and serious bipartisan effort in Congress would ensue to develop a public policy that really puts public health and kids first and money second."
ACS, which is a member of a coalition of 11 organizations, will lobby for legislation that would both limit tobacco use and increase funding for biomedical research, Seffrin said.
In a statement made at the Oval Office September 17, 1997, Clinton said any tobacco control legislation would have to include five elements:
Clinton said the suits by the attorneys general and individual plaintiffs brought the industry to the bargaining table, creating "an unprecedented opportunity to enact comprehensive tobacco legislation."
"Today, I want to challenge Congress to build on this historic opportunity by passing sweeping tobacco legislation that has one goal in mind: the dramatic reduction of teen smoking," Clinton said. "In the coming weeks I will invite congressional leaders from both parties to the White House to launch a bipartisan effort to enact such legislation."
Well before the President made his statement in the Oval Office, legislators and anti-tobacco groups began to stake out claims for tobacco control measures that would finally clear Congress. One piece of legislation, now being drafted by Senators Tom Harkin (D-IA) and Connie Mack (R-FL), is expected to eliminate the ability of the tobacco companies to claim tax deductions for payments made to settle health claims and establish a new funding source for biomedical research. The legislation would not be contingent on the national settlement between tobacco companies and the attorneys general, and would be viable even if the tobacco industry ends up reaching separate settlements with the states, sources said. Under the proposed settlement with the attorneys general, tobacco companies would be able to deduct the $368 billion they are obligated to pay out over the next 25 years, a provision that could return as much as $100 million to the industry. Sources said the legislation now being drafted by Harkin and Mack would amend the U.S. tax code to eliminate this deduction and channel the funds to medical research at NIH.
In a recent letter to the President, Harkin and Mack said the payments by tobacco companies should be regarded as penalties rather than lawsuit settlements or fines. "Forcing the tobacco companies to pay $368 billion over 25 years and then allowing them to receive about one-third of it back from the IRS is simply wrong," Harkin and Mack wrote. "Think what $100 billion could mean for medical science. Researchers all across this country are on the verge of amazing new medical discoveries to unlock the mysteries of medicine to find cures for diseases such as cancer, Alzheimer’s or juvenile diabetes."
Reacting to the President’s speech, Mack challenged the White House to provide specific legislative language rather than rhetoric. "The President, whose representatives were involved in crafting the details of the tobacco settlement, should have provided Congress and the American people with more than just a speech," Mack said in a statement. "Rhetoric makes poor legislation. I am hopeful the President will sit down with Congress to craft the specifics of the legislation in the coming months."
ACS executive Seffrin said the Harkin-Mack plan appears promising. "I think any proposed legislation that would increase the price of tobacco products, protect kids, and support biomedical research is worthy of serious consideration," Seffrin said. ACS is a member of a coalition that was organized specifically to lobby for tobacco control. Members of the coalition include the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Chest Physicians, the American College of Preventive Medicine, the American Heart Association, the American Medical Association, the Association of City and Territorial Health Officials, Campaign for Tobacco-Free Kids, National Association of County and State Health Officials, and Partnership for Prevention. Seffrin said the coalition is inviting new member organizations. "I imagine this list will be broadened tenfold over the next few months, as people see how this could be a watershed event for public health and biomedical science," he said.
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THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY CALLS FOR REVIEW OF U.S. TOBACCO TRADE POLICIES |
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TopBernard Fisher Settles Suit...Immunex to Market Generic...Brain Stores Speech Function...President Clinton Deals Blow...The American Society of... |
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Though the ASCO statement refers to the proposed settlement agreement between the tobacco industry and the attorneys general, the society’s proposals can be incorporated into other legislation, society officials said. "The settlement, while a step in the right direction, does not go far enough in protecting the public health, especially in reducing tobacco use among young people," said ASCO president Robert Mayer. "As oncologists who see first-hand the deadly consequences of continued tobacco use, we strongly support the position that the tobacco industry should be held accountable for knowingly promoting products that are harmful and addictive," Mayer said.
The excerpted text of the ASCO statement follows:
"The FDA has a longstanding tradition of establishing rigorous standards and procedures for regulating drugs and devices. The pharmaceutical and medical device industries, which make products that save lives, are required to meet those standards. The tobacco industry, which sells products that cause disease and death, should not be given special treatment.
"FDA should be allowed to regulate nicotine and tobacco products as it would any other drug or device. ASCO calls for the removal of any substantive or procedural limits on FDA’s regulatory authority in this area.
"As a public health matter, ASCO recognizes that an immediate ban on nicotine could pose great problems for the 77%-92% of adult tobacco users who are addicted to nicotine. Thus, ASCO acknowledges there may have to be a phase-in period for full FDA authority over tobacco. That period, however, should be no more than six years, during which time there should be more research and other funds directed toward expediting the development and distribution of more effective smoking cessation products and therapies.
"ASCO’s policy statement advocates a substantial increase—in the range of $2.00 per pack—in the federal excise tax on cigarettes or other tobacco products. That policy is based on the economic evidence that price increases lead to decreased consumption, particularly among underage tobacco users. The settlement agreement calls for "look-back" provisions to set targets for reduced youth smoking. As of the fifth year of the settlement, the industry must show a 30% reduction in underage smoking and a 25% decline in underage use of smokeless tobacco, with additional targets thereafter. If the industry fails to meet such targets, there is an $80 million penalty for each percentage point below the goal, up to a cap of $2 billion annually, with the possibility of significant rebates.
"ASCO’s overriding goal is to prevent children from using tobacco and the look-back targets help accomplish that goal. But ASCO is concerned that the proposed penalties are insufficient incentives to achieve the desired reduction. Therefore, in addition to a capped monetary penalty, the settlement agreement should also rely on excise tax increases, which have a track record in reducing consumption, as the fail-safe mechanism. The significant health risks associated with tobacco use outweigh any concerns that such taxes may be perceived as regressive.
"The excise tax program should be implemented consistent with the approach adopted for the look-back provisions. For every percentage point below the goal, there should be an automatic increase, in the range of 10 cents, in the federal excise tax on tobacco and smokeless tobacco products. For example, if there is only a 15% reduction in underage smoking in the fifth year, there will be an additional $1.50 federal excise tax on tobacco products in the sixth year. This same formula would be applied to smokeless tobacco products. The total tax may be greater if a state or local government decides to impose its own excise tax on tobacco. Thus, if the tobacco industry reaches the reduction targets, there will be no automatic federal tax increase, but if they fail, the tax will be added in order to achieve reduced consumption. Monies from both the look-back penalties and the excise tax should be used to supplement the Public Health Trust Fund.
"ASCO members know all too well how difficult it is to treat cancer, particularly the cancers associated with tobacco use. The key to improving this situation is research on basic mechanisms involved in cancer; identification of susceptibility genes and current and former smokers at highest risk for cancer, and development of effective chemoprevention, new diagnostic tests, and improved treatment options for tobacco-related diseases. That is why ASCO is encouraged that the settlement agreement funds a $25 billion Public Health Trust Fund. But it is essential that the trust fund establish a rigorous, science-based, peer-review system to award research grants. Otherwise, we run the risk of wasting valuable research dollars on projects that do not expand the current state of knowledge. Scientific expenditures through the trust fund should be patterned after the existing grants program administered by NIH; one possibility is that it be administered by the NIH.
"Research priorities must be sufficiently defined in order that an expanded scientific effort be focused and well coordinated:
"According to the World Health Organization, smoking kills approximately three million people worldwide each year. If current trends continue, that figure will grow to 10 million deaths annually by the year 2025. The enormity of this problem is exacerbated by United States’ trade policies that encourage the export of tobacco products, particularly to less-developed countries. ASCO believes these policies are unconscionable and perverse. Our society feels a particular responsibility to address this problem because 20% of our members and more than 50% of participants in our scientific and educational meetings are from outside the United States.
"The settlement agreement omits the tobacco export issue. That silence is morally unacceptable. Tobacco is not just another exported commodity. As evidenced by the settlement itself, it is a highly addictive substance that causes pain, suffering and death. Those problems occur whether tobacco is consumed in this country or abroad. ASCO urges that the settlement call for a full-scale Presidential review of all U.S. trade policies that affect tobacco and tobacco products and shift those policies, either by executive order or through legislation, to discourage, rather than encourage, such exports. Moreover, exports can be further discouraged by funding a retraining program for America’s tobacco farmers to wean them off this cash crop. In addition, the warning labels and packaging restrictions detailed in the settlement agreement for domestic products should be retained for exported products to foreign markets that have not already developed comparable requirements."
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FOOTNOTES |
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