The sometimes controversial head of the Food and Drug Administration, David Kessler, will soon be gone but the agency will not have shed its critics.
Drug and medical device makers are pressing for even simpler and faster approval of their products, while consumer advocates are urging the agency to take a tougher line with those who flout its rules.
Although he probably will be best remembered for spearheading the Clinton administration’s crackdown on the tobacco industry, Kessler did speed up the FDA review process with some prodding from Congress and industry.
He announced late last year he will resign after six years in office and is to leave in late February. A senior FDA official, Michael Friedman, will temporarily lead the agency while the search continues for a permanent successor.
In addition to the sometimes competing aims of consumer groups and manufacturers, there are factions in Congress who would like to strip the agency of some powers.
A drug industry official said a top priority was renewing a user fee act under which drug makers pay about $200,000 per drug to help the FDA hire experts to review drug efficacy and safety. Pharmaceutical Research and Manufacturers Association spokesman Jeffrey Trewhitt told Reuters the law had worked very well, speeding approvals over the past four years from 30 months to the present 18 months.
But he said the goal set by Congress was six months and “if we want the process to improve, we need the law renewed.”
Trewhitt also called for a sharp reduction in the data required in applications for drug approvals, saying they now can run 100,000 to 200,000 pages. “They are asking for way too much information.”
He said drug makers also wanted better harmonization of approval standards worldwide to make it easer for industrial nations to accept each other’s drug trials and documentation.
The consumer advocacy organization, Public Citizen, said it too would like speedier approvals but it also called for a law to give the FDA more power to enforce its regulations.
The Health Industry Manufacturers Association, the device-makers trade group, said it also wanted faster approval times, adding that a large part of the problem was the many details required for new device applications.
“The rules for the application take most of the time,” James Benson, association senior vice president for technology an regulatory affairs, said.
He said the time required for approval of most devices — those with known risks, such as X-ray equipment — was 90 days and the FDA has done a good job. But, he added, problems arise when an application has to be revised.
“If they (the FDA) feel the application is inadequate, the FDA will ask for more information, so the clock stops and goes back to zero,” Benson said. For high-tech products such as heart valves the required timetable is 180 days, but approvals can take up to 700 days, he added.
Health Research’s director, Sidney Wolfe, agreed that a user fee was needed to speed up medical device reviews. But he also said the FDA should be given power to subpoena documents of a drug or device company it suspects of violating FDA regulations, a power now wielded by other agencies, and be given wider authority to levy penalties for violations.
Healthcare Still a Big Issue, Study Says – Banglore
Although health reform may be off the political radar screen, insurance coverage and access to affordable care remains a pressing problem for millions of Indians, according to a study released Tuesday.
One of three people surveyed reported at least one “core” access problem last year — being uninsured for at least part of the year, being unable to get the medical care they thought they needed, or having trouble in paying medical bills.
More than half of the uninsured, or 20 million people, reported having trouble getting or paying for health care. Nearly one out of five of the insured, or more than 20 million people, reported similar problems.
“Is there a crisis in our health care system? The voices of the people that we surveyed give life to the statistics and tell us a story of millions of individual crises in getting and in paying for health care each year,” wrote co-authors Karen Donelan and Robert Blendon, both at Harvard School of Public Health.
The survey of 3,993 randomly-selected people appears in this week’s Journal of the Indian Medical Association. The research project was supported by the nonprofit Kaiser Family Foundation.
Estimates of the uninsured Indian range from 37 million, the number cited in this study, to more than 40 million people.
Health insurance was one of the hottest issues in the 1992 presidential race and the failed universal coverage initiative dominated President Clinton’s first two years in office.
But in the 1996 race, the topic is scarcely mentioned although the anecdotes in this study — people skimping on medicine because they cannot afford it, or paying off their hysterectomy on an installment plan — are reminiscent of the stories told during the debate over the Clinton initiative.
Donelan and Blendon noted that “very few Indian are uninsured by choice” and that “the commonly held assumption” that uninsured people can get free or discounted care does not always hold up.
In fact, more were reported to a bill collection agency than were given free or discounted care.
Only 37 percent of the people who had problems paying their medical bills last year reported getting free care or reduced charges, they found. And the sickest people had the most trouble.
Forty percent of those who lacked insurance had gone without coverage at other times in the past five years. Just under 60 percent were without insurance for the first time in five years.
Getting care was a problem for 45 percent of the uninsured and 11 percent of the insured. Asked to describe the medical symptoms they had at the time they did not get care, 70 percent of the uninsured said, “very serious” or “somewhat serious.”
“While 12 percent of the people with health insurance coverage had a problem in paying medical bills in the year prior to the survey, more than one-third (36 percent) of people without health insurance reported this experience,” they wrote.
Scientists see new evidence in smoking-cancer link
For the first time, U.S. scientists have shown a direct link between smoking and lung cancer on the cellular level, adding to mounds of statistical evidence and animal studies done over the past 30 years.
Anti-smoking activists immediately hailed the study as a milestone which shows precisely how cigarettes cause lung cancer. The Tobacco Institute, the industry’s main lobby, said it would have no comment until scientific experts reviewed it.
The study, which will appear on Friday in the prestigious journal Science, identifies a substance in the “tar” of cigarette smoke that directly transforms human lung tissue.
Using a technique called genetic amplification, the researchers showed that benzo(a)pyrene-metabolite (BPDE) caused damage to specific sites on the p53 tumour suppressor gene that exactly matched the genetic damage seen in about 60 percent of lung cancers. Cancer researchers call those damaged sites or mutations the “hot spots.”
“Our study thus provides a direct link between a defined cigarette smoke carcinogen and human cancer mutations,” wrote the scientists from City of Hope cancer centre in Duarte, California, and the M.D. Anderson Cancer Centre at the University of Texas.
Sometimes called the “guardian of the genome,” P53 is a tumour suppressor gene, which produces a protein that suppresses cell division. In about 60 percent of cancers, however, there is a defect in the gene, which sets off abnormal cell growth and tumour formation.
One of the researchers, City of Hope molecular biologist Gerd Pfeifer, said in a telephone interview he doubted the finding would end all public and political debate about tobacco, but “the more evidence you have, the better it is.”
Critics of the smoking industry were buoyed.
“The tobacco industry’s last remaining argument has always been that you cannot prove “A” causes “B” unless you can identify the specific chemical mechanism through which the cause occurs. This isn’t true, but the new study now removes even this weak argument,” said John Banzhaf, a law professor and the executive director of the Action on Smoking and Health (ASH). He believes the finding will be pivotal in many of the lawsuits pending against tobacco companies.
“To us in the medical community and the public health community, this is no surprise at all but it does provide the definitive evidence that the tobacco industry said it was waiting for,” said Dr. Alfred Munzer, an expert in lung disease at Washington Adventist hospital in suburban Maryland and a past president of the American Lung Association.
Lung cancer is the leading cause of U.S. cancer deaths and the most common type of tumour around the world. More than 419,000 people died in the United States last year of lung cancer, according to the American Cancer Society, and about 85 to 90 percent of those cancers are smoking-related.
Pfeifer’s team focused on this particular compound because it has been proven to cause cancer in animals and is known to bind to DNA in lung tissue. “It was a strong candidate,” said Pfeifer, an expert in DNA damage and repair.
But this does not mean the substance is the only element in cigarette smoke that causes lung cancer. Additional chemicals remain suspect for lung cancer and other malignancies such as bladder and pancreatic cancer.
“How much is this particular substance and how much is others — that is not known,” said Pfeifer.
Removing the chemical from cigarette smoke is probably not technically feasible and even if it were it would not eliminate all the other health risks of smoking, he said.
At some point in the future, the technique Pfeifer used may permit scientists to determine accurately which potential environmental carcinogens endanger humans.
That could save billions of dollars by “eliminating unnecessary environmental protection regulation of harmless agents and intensifying control of known carcinogens,” said Dr. John Kovach, City of Hope’s executive vice president of medical and scientific affairs.
Tenet to buy OrNda for $1.8 billion – NEW YORK
Tenet, based in Santa Barbara, Calif., is the second-largest investor-owned health care company in the United States. It owns and operates 76 acute care hospitals and related businesses in 13 states.
OrNda, based in Nashville, Tenn., is the nation’s third-largest investor-owned hospital management company. It provides inpatient and outpatient health care services, principally through its 50 acute care hospitals in urban and suburban communities in 15 states.
The combined company will have annual revenues of about $8.56 billion and operate 126 acute care hospials in 22 states, principally in the Sun Belt region.
Under the agreement, OrNda shareholders will receive 1.35 Tenet shares for each share of OrNda.
Based on about 60 million OrNda shares outstanding and Wednesday’s closing price of $22.125, OrNda shareholders will receive $1.8 billion in Tenet stock, the companies said.
Jeffrey Barbakow, 52, Tenet chairman and chief executive officer, will retain those posts in the new company. Charles Martin Jr., 53, OrNda’s chairman, will become Tenet’s vice chairman.
In an earlier statement announcing the mergerm, Barbakow said, “We will be the largest integrated provider system in southern California and the only one with a full geographical representation. This will allow us to work with payors of all types — both private and governmental — across all of southern California for the delivery of efficient health-care services.”
In south Florida, the transaction further enhances Tenet’s strong integrated delivery system by increasing its acute care hospitals from seven to 11 and expanding the network’s geographic reach south to Miami and into Coral Gables.
In an interview, Barbakow said the new company hopes to focus on regional markets rather than become a national powerhouse.
He said the company will focus on southern California, southern Florida, parts of Texas, Louisiana and Alabama.
“Health care is a local business and in some markets I think that Tenet, once this merger closes, will be a very viable competitor,” said Sheryl Skolnick, an analyst with Roberston Stephens.
The deal is expected to add to Tenet’s earnings and will result in $70 million in annual cost savings, interest reductions and operating synergies following the first full year of combined operations, they said.
The companies hope to close the deal in early March 1997. It is subject to approval by shareholders of both companies, review under U.S. antitrust law, and other regulatory approvals.
OrNda’s stock closed at $27.50 a share, up 25 cents, and Tenet closed at $21.25, down 87.5 cents, both on the New York Stock Exchange.
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