Archive for the ‘FDA’ tag
The Food and Drug Organization is still beholden to the industries it is supposed to regulate, putting us, the non-corporations, needlessly at risk in order to protect profits of industry. If we had a liberal, socialist president, perhaps this could change. However…
In February, a group of Food and Drug Administration scientists published a study finding that low-level exposure to the common plastic additive bisphenol A (BPA) is safe. The media, the chemical industry, and FDA officials touted this as evidence that long-standing concerns about the health effects of BPA were unfounded. (“BPA Is A-Okay, Says FDA,” read one Forbes headline.) But, behind the scenes, a dozen leading academic scientists who had been working with the FDA on a related project were fuming over the study’s release—partly because they believed the agency had bungled the experiment.
On a conference call the previous summer, officials from the FDA and the National Institutes of Health (NIH) had informed these researchers that the lab where the study was housed was contaminated. As a result, all of the animals—including the supposedly unexposed control group—had been exposed to BPA. The FDA made the case that this didn’t affect the outcome, but their academic counterparts believed it cast serious doubt on the study’s findings. “It’s basic science,” says Gail S. Prins, a professor of physiology at the University of Illinois at Chicago, who was on the call. “If your controls are contaminated, you’ve got a failed experiment and the data should be discarded. I’m baffled that any journal would even publish this.”
Yet the FDA study glossed over this detail, which was buried near the end of the paper. Prins and her colleagues also complain that the paper omitted key information—including the fact that some of them had found dramatic effects in the same group of animals. “The way the FDA presented its findings is so disingenuous,” says one scientist, who works closely with the agency. “It borders on scientific misconduct.”
(click here to continue reading Scientists Condemn New FDA Study Saying BPA Is Safe: “It Borders on Scientific Misconduct” | Mother Jones.)
A fan of Peapod
reminds me of the climate change debate, and not in a positive light:
In contrast to the FDA’s recent paper, roughly 1,000 published studies have found that low-level exposure to BPA—a synthetic estrogen that is also used in cash register receipts and the lining of tin cans—can lead to serious health problems, from cancer and insulin-resistant diabetes to obesity and attention-deficit disorder. In some cases, the effects appear to be handed down, with the chemical reprogramming an individual’s genes and causing disease in future generations.
But the agencies that regulate BPA and other chemicals have largely ignored this research in favor of industry data showing BPA is safe. A 2008 investigation by the Milwaukee Journal Sentinel revealed that the FDA had relied on industry lobbyists to track and evaluate research on BPA. It also found that the agency’s assessment of BPA’s safety was based largely on two industry-funded studies—one of which turned out to have “fatal flaws,” according to leading researchers in the field. Both studies also relied on a breed of rat, known as the Charles River Sprague Dawley, that is all but immune to the effects of synthetic estrogens like BPA.
On one hand, nearly 1,000 studies saying at the minimum, there could be potential health problems associated with the usage of this plastic; and on the other finger, 2 studies, flawed in methodology, and funded by the plastic and chemical industry that claim everything is fine as it is. In a rational world, these two studies would be marginalized. Instead, the FDA uses them as a fig leaf to protect the industry from regulation. Pathetic, and troubling.
Hmm, maybe if I started a religion that said ingesting BPA was against my core beliefs, we could take this to the Supreme Court…
Not the first time, sadly.
A casual reader taking in my account and the New York Times’ account of yesterday’s big FDA antibiotics announcement might have thought we were reacting to different events. Here’s the Times lead:
Farmers and ranchers will for the first time need a prescription from a veterinarian before using antibiotics in farm animals, in hopes that more judicious use of the drugs will reduce the tens of thousands of human deaths that result each year from the drugs’ overuse.
In the Times’ reading, the FDA placed significant restrictions on antibiotics use. My take was more critical: “The plan contains a bull-size loophole—and is purely voluntary, to boot.”
What gives? In short, the Times delivered a skim-level, FDA-friendly account of the new plan. Let’s start with the loophole. Here’s the Times:
Michael Taylor, the F.D.A.’s deputy commissioner for food, predicted that the new restrictions would save lives because farmers would have to convince a veterinarian that their animals were either sick or at risk of getting a specific illness. [Emphasis added.]
The bolded part is the key. As I reported yesterday, the FDA plan intends to phase out the use of antibiotics as growth promoters, but allows them to continue to be used to “prevent” disease. That’s a major loophole—it means that farmers can continue stuffing animals together in filthy conditions and dosing them with antibiotics to keep them alive. Margaret Mellon, senior scientist at the Union of Concerned Scientists and a longtime watchdog of the meat industry’s antibiotic-gorging ways, put it like this in a Wednesday press release:
The outlined process appears to give the companies the opportunity to relabel drugs currently slated for growth promotion for disease prevention instead. Such relabeling could allow them to sell the exact same drugs in the very same amounts
None of this comes out in the Times story.
(click here to continue reading How the NY Times Got It Wrong on the FDA’s New Antibiotics Rules | Mother Jones.)
Margaret Mellon responds, angrily:
FDA to Establish Voluntary, Largely Secret Program to Reduce Antibiotic Overuse in Agriculture Statement by Margaret Mellon, Senior Scientist
WASHINGTON (April 11, 2012)—The U.S. Food and Drug Administration (FDA) today released three documents that constitute its long-awaited response to the problem of antibiotic overuse in agriculture. There is wide recognition among scientists that such antibiotic use is driving up the rate of antibiotic-resistant diseases, which are becoming increasingly severe and more costly to treat. While the documents establish a new, completely voluntary approach to reducing antibiotic use in agriculture, the Union of Concerned Scientists cautioned that the program’s shortfalls are likely to imperil its success.
Below is a statement by Margaret Mellon, senior scientist at UCS.
“The approach announced represents a bold, well-intentioned attempt by the FDA to persuade an entire industry to voluntarily abandon claims that allow them to sell a large number of lucrative products. The agency should be congratulated for finally taking action on a serious and long-neglected public health issue, but we’re deeply skeptical that the approach will work.
“We have no reason to believe that the veterinary pharmaceutical industry—which, to date, has rarely even acknowledged that antibiotic resistance is a serious public health issue—will cooperate with the agency on a plan that could reduce its profits.
“The outlined process appears to give the companies the opportunity to relabel drugs currently slated for growth promotion for disease prevention instead. Such relabeling could allow them to sell the exact same drugs in the very same amounts. The process also allows companies to avoid risk assessments for new drug approvals.
“Unfortunately, the process will also be secret. Companies will have three months to submit voluntary plans and three years to implement them. During this entire time, the public will be kept in the dark. It could be three to four years before anyone knows how well the program is working.
“Ultimately, if antibiotic use is reduced only marginally or not at all much time and taxpayer dollars will have been wasted.
“The agency doesn’t need to embark on this novel but very risky experiment in relying on companies to police their own products. It has – and should have relied upon – its authority under the Food, Drug and Cosmetic Act to cancel unsafe uses of drugs.”
(click here to continue reading FDA to Establish Voluntary, Largely Secret Program to Reduce Antibiotic Overuse in Agriculture | Union of Concerned Scientists.)
Lovely. What’s next? Asking ExxonMobile to conduct its own environmental studies for the EPA? Asking G.E. to do its own tax audits for the IRS? We expected better than this from Obama’s administration.
The U.S. Food and Drug Administration introduced a pilot project in the Federal Register this month which would allow biotech seed companies to perform their own environmental impact studies of novel seed varieties before deregulation. The USDA’s move seems to be a response to a decision last August by Federal Judge Jeffrey White which banned the planting of genetically modified sugar beets until an environmental study assessed the impact of commercial cultivation. White ruled that the USDA’s approval of the beets violated the National Environmental Policy Act.
Proponents of the USDA’s project believe the decision will make the biotech industry less vulnerable to legal challenges and speed the registration process of new GE crops. “A big deterrent to future lawsuits would be if the USDA were to win some of them,” said Karen Batra, director of communications at Biotechnology Industry Organization, to Capital Press. “The more information the department has, the better case they can make.”
Most recently The Center for Food Safety challenged the USDA’s unregulated approval of GE-alfalfa saying the decision puts organic and conventional farmers at risk. The case is pending.
Organic advocates believe the USDA’s pilot will slow what they believe to be an already ineffective process and encourage more legal challenges.
“There’s virtually no chance, in the current political climate, that the idea of expanding the role of biotech is going to speed up approval,” said Chuck Benbrook, chief scientist for The Organic Center. “The fact of the matter is there are many good reasons not to trust science from Monsanto. Almost inevitably the first assessments carried out under this pilot program will be challenged in court—probably successfully.”
Bill Freese, science policy analyst for the Center for Food Safety, said the USDA’s proposal would make an already poor process worse.
“This decision would give us additional incentive to challenge a seed up for deregulation, subject to other factors,” he said. “We might actually challenge the process itself. This decision seems to go against some pretty basic scientific integrity guidelines. Letting a company do its own assessment is a pretty obvious conflict of interest.”
(click here to continue reading USDA suggests Monsanto do its own environmental impact studies | Farming content from New Hope 360.)
Each year, federal inspectors find illegal levels of antibiotics in hundreds of older dairy cows bound for the slaughterhouse. Concerned that those antibiotics might also be contaminating the milk Americans drink, the Food and Drug Administration intended to begin tests this month on the milk from farms that had repeatedly sold cows tainted by drug residue.
But the testing plan met with fierce protest from the dairy industry, which said that it could force farmers to needlessly dump millions of gallons of milk while they waited for test results. Industry officials and state regulators said the testing program was poorly conceived and could lead to costly recalls that could be avoided with a better plan for testing.
In response, the F.D.A. postponed the testing
(click to continue reading F.D.A and Dairy Industry Spar Over Testing of Milk – NYTimes.com.)
The FDA even says, bluntly, that they don’t give a shit about consumers:
The F.D.A. said that it would confer with the industry before deciding how to proceed. “The agency remains committed to gathering the information necessary to address its concern with respect to this important potential public health issue,” it said in a statement.
The House of Representatives gave final approval on Tuesday to a long-awaited modernization of the nation’s food safety laws, voting 215 to 144 to grant the Food and Drug Administration greater authority over food production.
(click to continue reading House Passes Overhaul of Food Safety Laws – NYTimes.com.)
…the devil is in the details1. For instance, some of the implementation doesn’t start until five years from now, some not until 18 months from now, and with the risk that the whole thing will get changed by then since our country inexplicably elected Republicans to be the majority party in the 112th Congress
“The F.D.A. asked for and was given a very long lead time for implementation,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, an advocacy group. “But it’s still a vast improvement over what we have today.”
Ultimately, the agency’s ability to carry out and enforce the law will depend on how much money it has available to pay inspectors and maintain or increase its staff. Republicans will gain control of the House next year and have vowed to cut spending on many domestic programs. Deep cuts could hobble the F.D.A. just as it gains the new authority.
“It’s going to be crucial for the next Congress to recognize that F.D.A. can’t fulfill the promise of this new law without the resources it needs to do the job,” said Erik D. Olson, who heads food policy for the Pew Health Group, an advocacy organization.
- whatever the frack that means [↩]
Follow up on the AquaBounty Frankenfish FDA hearing held yesterday…
Still some panel members did say the studies the F.D.A. relied on to reach its own conclusion that the salmon would be safe were flawed, often using only a few dozen fish or even fewer.
“I do get heartburn when we’re going to allow post-market surveillance to finalize our safety evaluation,” said one committee member, Michael D. Apley, a pharmacology expert at Kansas State University.
The criticisms could add to the time needed to approve the salmon. It could also provide grist for consumer and environmental groups, many of which testified on Monday that the salmon should not be approved.
Approval of the salmon could pave the way for other such biotech animals to enter the food supply, like a pig developed in Canada that has more environmentally friendly manure.
(click to continue reading Step Forward for Genetically Engineered Salmon – NYTimes.com.)
Humanity has been modifying food since agriculture was invented, but grafting apple saplings or breeding milk cows is not quite the same as modern techniques. It could be absolutely harmless, but I don’t see the need to rush the salmon to market without conducting comprehensive, exhaustive tests. Especially because the reality of a laboratory is much different than the reality of a factory farm, especially after a decade of production.
The company said that fish would not escape because they are grown inland in facilities with containment mechanisms. If any did escape, it said, the rivers outside the Canadian and Panama facilities would be too salty or warm for the fish to survive. And the fish would all be female and almost all would be sterile, so they would not interbreed with wild salmon.
But some committee members, as well as some environmental groups, said the government’s environmental assessment should evaluate what would happen if the salmon were grown widely in many facilities.
“The F.D.A. must consider issues related to realistic production scenarios,” said Anna Zivian, a senior manager at the group Ocean Conservancy.
One test showed a possible increase in the potential to cause allergic reactions that was almost statistically significant even though only six fish were used in each group in the study.
More tests please…
Unlabeled genetically engineered salmon: such a crowd pleaser that the FDA is working overtime to change the subject and make excuses, and the AquaBounty “fish” isn’t even on the market yet. Too bad we don’t have any regulatory agencies that are concerned with public opinion, and public safety.
The FDA’s apparent readiness to approve the AquaBounty salmon has inflamed a coalition of consumer, environmental, animal welfare and fishing groups, who have accused the agency of basing its judgment on data compiled from small samples supplied by the company, rushing the public portion of the review process and disclosing insufficient information about the fish.
The FDA does not have an approval process designed specifically for genetically engineered animals and is evaluating the salmon under the process used for new veterinary drugs. That means that much of the data provided to FDA to demonstrate the safety of the fish is considered a trade secret.
The process doesn’t allow enough public participation, doesn’t give the FDA enough leeway to consider environmental factors and doesn’t give the agency enough power to withdraw the salmon from the market if something should go wrong, said Greg Jaffe, director of the Biotechnology Project for the Center for Science in the Public Interest and a member of the FDA advisory committee that will evaluate the agency’s findings.
(click to continue reading FDA advisors to vote on genetically engineered salmon – latimes.com.)
So is this frankenfish safe to eat or not? I couldn’t tell you, but I’d sure like the FDA to conduct more tests instead of rushing this beast to market.
Surprise, surprise, another federal regulatory agency more concerned with the industry it is supposed to oversee than with the public it is allegedly supposed to protect and serve. If the USDA was a person, it could be jailed for crimes, but…
U.S. Department of Agriculture experts found growing sanitary problems including bugs and overflowing trash earlier this year on the Iowa farm at the center of the national egg recall, but didn’t notify health authorities, according to government documents and officials.
The problems laid out in USDA daily sanitation reports viewed by The Wall Street Journal underscore the regulatory gaps that may have contributed to delays in discovering salmonella contamination. Tainted eggs sickened at least 1,470 Americans.
Wright County Egg of Galt, Iowa, recalled 380 million eggs in mid-August, but people likely began getting ill around May 1, according to the Centers for Disease Control and Prevention.
Robert Arnold said he reported problems at Wright County Egg when he worked there, but was ignored.
The USDA was the only federal body with a regular presence at Wright, but it says it wasn’t responsible for safety. USDA graders were at a Wright egg-packing plant seven days a week to oversee designations such as “Grade A” on egg cartons.
The Food and Drug Administration, which has overall responsibility for egg safety but didn’t inspect the Wright facility until this August, says it never heard from the USDA about problems such as dirt and mold. The two agencies have a formal understanding about the USDA giving the FDA notice over sanitary issues, but the USDA declined to give details.
The USDA said it didn’t give notice because “the conditions at the egg plant packing facilities were routine.”
(click to continue reading Egg Inspectors Failed to Raise Alarms – WSJ.com.)
Routine. Yikes. That makes me feel like eating 50 eggs!
Why is food safety such a low priority in Washington? How many people have to be sickened by agribusiness and factory farming methods before reform is undertaken? Are farm lobbyists really so powerful that the Senate has been sitting on Durbin’s Bill S. 510 for years? Unconscionable.
The latest action — the third recall announcement in two weeks for eggs — is bound to shake the confidence of consumers rattled by a succession of food safety scares in recent years, most prominently for foods like beef and lettuce.
The idea that half a billion suspect eggs have been circulating in the food supply comes as an embarrassment for the egg industry and federal regulators. New egg safety rules went into effect in July that the Food and Drug Administration had said would prevent tens of thousands of salmonella illnesses a year.
“You have to treat eggs with the assumption that they’re contaminated with salmonella,” said Carol Tucker Foreman, a food safety expert of the Consumer Federation of America. “We may all object to the fact that we have to treat food like toxic waste, but if we don’t want to get sick, and especially if you have someone in your house that’s immune-suppressed, you have to handle things carefully and demand that the standards be set higher.”
(click to continue reading Second Iowa Producer Recalls 170 Million Eggs – NYTimes.com.)
The FDA has been too lax for too long, and needs to be inculcated with a new mission, namely protecting consumers instead of the industry it purportedly regulates.
Ru-oh. Yet again the FDA is ignoring problems instead of figuring out a plan to fix them, shirking its responsibility, and Washington co-signs.
Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found.
The levels of heavy metals — including mercury, cadmium and arsenic — did not exceed thresholds considered dangerous, the investigators found. However, 16 of the 40 supplements tested contained pesticide residues that appeared to exceed legal limits, the investigators found. In some cases, the government has not set allowable levels of these pesticides because of a paucity of scientific research.
(click to continue reading Herbal Supplements Often Have Contaminants, Study Finds – NYTimes.com.)
Don’t understand why the FDA doesn’t take the time to test supplements for pollutants. What’s the downside? Is the American Chemical Council afraid of the answers? Namely, that pesticides and pollutants are in nearly every single item we consume, including vitamins and herbs?
This troubles me.
Senator Herb Kohl, a Wisconsin Democrat who will preside over Wednesday’s hearing of the Senate Special Committee on Aging, said that while improvements had been made in recent years in the oversight of supplements, “the F.D.A. needs the authority and tools to ensure that dietary supplements are as safe and effective as is widely perceived by the Americans who take them.”
Among the witnesses at the hearing will be Dr. Tod Cooperman, president of ConsumerLab.com, a company that has tested over 2,000 dietary supplements made by more than 300 manufacturers and has found that one in four have quality problems. According to Dr. Cooperman’s written testimony, the most common problems are supplements that lack adequate quantities of the indicated ingredients and those contaminated with heavy metals.
Travis T. Tygart, chief executive of the United States Anti-Doping Agency, wrote a letter to the committee saying that some athletes have been rendered ineligible for international competitions because they took supplements that contained steroids not listed on the products’ labels. There are thousands of supplements available for sale that contain steroids or other harmful ingredients, he wrote.
But this really troubles me:
In recent years, a vast majority of supplement suppliers have located overseas — principally in China. Nearly all of the vitamin C and many other supplements consumed in the United States are made from ingredients made in Chinese plants. Those plants are almost never inspected by the F.D.A. because the agency is not required to do so, has little money to do so and does not view the plants as particularly risky.
Made in China often means profit over quality, and lax oversight. Scary, if you consider the amount of vitamins and supplements that Americans consume.
Well, you know what I mean.
A Princeton University research team has demonstrated that all sweeteners are not equal when it comes to weight gain: Rats with access to high-fructose corn syrup gained significantly more weight than those with access to table sugar, even when their overall caloric intake was the same.
In addition to causing significant weight gain in lab animals, long-term consumption of high-fructose corn syrup also led to abnormal increases in body fat, especially in the abdomen, and a rise in circulating blood fats called triglycerides. The researchers say the work sheds light on the factors contributing to obesity trends in the United States.
“Some people have claimed that high-fructose corn syrup is no different than other sweeteners when it comes to weight gain and obesity, but our results make it clear that this just isn’t true, at least under the conditions of our tests,” said psychology professor Bart Hoebel, who specializes in the neuroscience of appetite, weight and sugar addiction. “When rats are drinking high-fructose corn syrup at levels well below those in soda pop, they’re becoming obese — every single one, across the board. Even when rats are fed a high-fat diet, you don’t see this; they don’t all gain extra weight.”
Curious as to why that is. Also, isn’t it nice that the federal government subsidizes high-fructose corn syrup, keeping its price artificially low? Low price means high fructose corn syrup is used as an ingredient more often than if was a specialty ingredient.
Follow up on the NYT article on GSK and their drug, Avandia that we blogged about recently
A Senate report that revives concerns about a GlaxoSmithKline PLC diabetes drug’s link to heart attacks is putting pressure on the Food and Drug Administration to make changes to its drug-safety program.
People familiar with the situation say agency leaders held calls over the weekend to discuss how to address complaints from Sens. Max Baucus (D., Mont.) and Chuck Grassley (R., Iowa), who released a new report Saturday on the Glaxo drug, called Avandia.
The FDA is trying to assemble a timeline of what the FDA knew of risks associated with Avandia, these people say, and plans to call a meeting of an outside advisory committee in the next few months to look at recent information on the drug, which Glaxo reported as having global sales of £771 million ($1.2 billion) in 2009.
According to a two-year investigation by the Senate Finance Committee, Glaxo knew about data linking Avandia to elevated risk of cardiovascular events for several years, but played down the information and tried to suppress doctors who raised concerns. Starting in 1999, Glaxo executives complained to superiors about researchers who questioned Avandia’s safety, the report says.
[Click to continue reading Glaxo Drug Faces More Scrutiny - WSJ.com]
and the FDA is certainly not blameless in this mess
Some critics of the FDA cited the Avandia report in renewing calls for an independent safety unit at the agency to track problems with drugs after they go on the market. Currently the section that does “post-market surveillance” is subordinate to the division that approves new drugs. As a result, there is an inherent conflict of interest because the approval officers are judging their own previous decisions, critics say.
The question is: will public outrage be sufficiently heated to force some structural changes in the FDA? Jury is still out…
In other corrupt-Washington-business-as-usual news, the pharmaceutical corporations have successfully protected their profits against generic drugs by convincing Washington to underfund the department of government regulators who approves generics. If they have no staff and no budget, generics can’t be brought to market, causing consumers and Medicare to spend more on non-generic drugs.
American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005.
The delays, caused by a growing backlog of applications at the Food and Drug Administration, may be costing consumers and the federal government hundreds of millions of dollars a year as they continue in some cases to pay for name-brand drugs even after their patents expire, industry analysts said.
[Click to continue reading New Generic Drugs Facing Longer Waits for Approval - NYTimes.com]
Currently, approvals are taking over 2 years to wade through. Obviously, this office of the FDA is not a priority.
With lawmakers preparing to meet at the White House next week to discuss ways to give more Americans access to health insurance, generic makers say that underfunding of the F.D.A.’s generics office is denying consumers access to more affordable drugs. The agency’s office of generic drugs has a budget of $51 million for fiscal year 2010, up from $41 million in fiscal 2009.
Executives at the generics meeting joked that government was spending less per year on reviewing applications for new generic drugs than the New York Yankees spend on the payroll of the left side of their infield. (Alex Rodriguez and Derek Jeter between them earned $54.6 million last year, according to ESPN).
but if Washington was serious about being cost-sensitive and fiscally responsible, they’d act already. Ultimately, delaying generic drugs ends up costing taxpayers more money
While accounting for the majority of drug prescriptions in the United States, generics represent just a fraction of the total cost of drugs. Generics accounted for 70.4 percent of the 2.9 billion prescriptions in the United States last year, according to IMS Health, a health information company. But they accounted for only about 15 percent of the $300 billion spent on prescription drugs in this country last year, IMS said.
The slowdown in new generic drug approvals ultimately hurts consumers — and government payers like Medicare — because prices stay higher when there are no or only a few generic alternatives to a branded drug, industry analysts said.
Sad state of affairs: almost as if pharmaceutical corporations like GlaxoSmithKline set national policy. Hmmm, maybe they do?
Speaking of Racketeer Influenced and Corrupt Organizations, GlaxoSmithKline wants to protect its drug profits at the expense of hundreds of deaths a year.
Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.
The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.
The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.
[Click to continue reading Diabetes Drug Avandia Harms the Heart, Studies Find - NYTimes.com]
GSK is more interested in resurrecting their cash cow:
Driven in part by a multimillion-dollar advertising campaign, sales [of Avandia] were $3.2 billion in 2006
despite the US Senate suggesting the process itself was/is flawed:
In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked “what steps the F.D.A. has taken to protect patients in the TIDE trial” and said the trial’s patients had never been told about the concerns raised by the agency’s own safety officers.
Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.
“It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Mr. Grassley said. “The Avandia case may be the most alarming example of the problem with this setup.”
The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems — including 304 deaths — reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.
The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.
Don’t forget that the FDA’s coziness with the pharmaceutical corporations is part of the problem too. Unless there are some drastic structural changes in the FDA, these sorts of issues are going to come up repeatedly.
No wonder the US model of pharmaceutical research is so fracked up.
In a report expected to be made public on Thursday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, said 90 percent of universities relied solely on the researchers themselves to decide whether the money they made in consulting and other relationships with drug and device makers was relevant to their government-financed research.
And half of universities do not ask their faculty members to disclose the amount of money or stock they make from drug and device makers, so the potential for extensive conflicts with their government-financed research is often known only to the researchers themselves, the report concluded.
[Click to continue reading Researchers’ Financial Interests Often Not Reported to U.S. - NYTimes.com]
Don’t ask, don’t tell, right? You keep your money, and we keep you on staff so that our university can use your name in our PR materials.
Most of the reported conflicts involved equity ownership in companies that could be affected by the results of government-financed research. In only a third of the cases did the universities specify to the government the size of the financial conflict and, among those, six had equity stakes valued at greater than $100,000. But in only 29 of the cases did the universities require researchers to reduce or eliminate their stakes. In most cases, the universities deemed that some sort of the disclosure of the conflict was enough to manage it.
Can you imagine this sort of arrangement for any other industry? Well, besides maybe defense contractors and Congress, but they at least have a couple of years of cushion between action and reward.