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Will the FDA Finally Get Out of Bed With Big Pharma?
A test case for the new government will be how it deals with the pharmaceutical industry, which rivals the gun manufacturers and tobacco companies for the position of most amoral industry in America.
Democrats have long been promising to stand up to Big Pharma on issues like Medicare drug pricing and importing drugs from Canada, but they've accomplished little since they won Congressional majorities in 2006. If they truly want to reign in the drugmakers now that they have the clout, they'll need to not only move forward on these hot-button issues, but also completely overhaul the Food and Drug Administration, which stands as one of the most corrupt and compromised bodies in the federal government today.
Last week offered a glimmer of hope, with a bipartisan bill aimed at one of the many scurrilous practices employed by drug companies to win swift approval for their products and push them on the public. Called the Physician Payments Sunshine Act of 2009, the legislation was introduced last Thursday by Senators Herb Kohl (D-WI), Chair of the Senate Special Committee on the Aging, and Charles Grassley (R-IA), in the past a rare Republican voice opposing some of Big Pharma's outrages. They are calling for establishment of "a nationwide standard requiring drug, device and biologic makers to report payments to doctors to the Department of Health and Human Services and for those payments to be posted online in a user friendly way for public consumption."
Let's be clear: The proposed legislation doesn't say that doctors can't receive money (or expensive dinners, or luxury junkets) while they are testing or endorsing new drugs; it merely says the payments have to be made public. Even this, however, has apparently proven too much for the Food and Drug Administration: A report released earlier this month found that the FDA had been sorely lax in demanding full disclosure of these relationships. As reported by Bloomberg News:
Drug regulators haven't done enough to force disclosure of financial conflicts of interest among the researchers who conduct clinical trials of medications and medical devices, according to a U.S. government investigation. A total of 42 percent of marketing applications approved by the U.S. Food and Drug Administration were missing financial information that was supposed to be submitted by drug and device makers, according to a report today by the Health and Human Services Department's inspector general. The FDA didn't act against the companies, the report said.The FDA has fallen a long way since 1962, when legendary Senator Estes Kefauver championed its expansion, insisting that it was the federal government's responsibility to protect the public by ensuring that prescription drugs were both safe and efficacious. The FDA has for decades been playing footsy with the drug industry, and it reached new lows under George W. Bush, as fundamentalist Christianity became yet another force undermining the agency's work. Bush's appointments to the FDA leadership included a veterinarian who presided over the Vioxx scandal and stalled the Plan B pill, and a faith-based gynecologist who refused to prescribe contraceptives to married women and advised prayer as a treatment for many female ailments.Financial connections between companies that make drugs and devices and the doctors and other researchers who test them on humans may compromise the safety of patients in studies and the integrity of the results, according to the inspector general's report. Lawmakers, led by Senator Charles Grassley, a Republican from Iowa, have raised concern that financial conflicts of interest among doctors and manufacturers may influence prescribing decisions.
In a 2006 survey of FDA employees, more than 40 percent said they knew of cases in which political appointees had interfered with agency decisions. At that time, more than 100 whistleblower cases were also pending at the agency. Some things will now surely change at the FDA--but how much, and how soon?
Obama has yet to announce his nominee for FDA commissioner, but HHS Secretary Tom Daschle talked about the agency at confirmation hearings earlier this month, promising "to ensure that trust in FDA is restored as the leading science-based regulatory agency in the world. ...I will send a clear message from the top that the President and I expect key decisions at the FDA to be made on the basis of science--period."
It's true that we're unlikely to see prayer meetings in Tom Daschle's HHS. But independence from Big Pharma is another story. Since leaving Congress, Daschle has been working as an "adviser" to health care industry clients, including at the law and lobbying firm Alston & Bird. As the New York Times reported at the time his nomination:
Although not a registered lobbyist, Mr. Daschle, a South Dakota Democrat who was party leader in the Senate, provides strategic advice to the firm's clients about how to influence government policy or actions....As examples of the firm's achievements the Web site lists matters involving Medicare and Medicaid reimbursements, approvals of federally regulated drugs and medical products, fraud investigations, medical waste disposal, privacy and other compliance issues.On the day Tom Daschle was nominated, the Washington Post's "The Ticker" blog reported:
According to Wall Street, Tom Daschle is a good choice to be the new secretary of the Department of Health and Human Services. Shares of the big drugmakers--Pfizer, Eli LIlly, Merck, GlaxoSmithKline and AstraZeneca--are all trading up from their opening this morning.
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10 Comments so far
Show AllThe FDA is just another set of regulators with their heads up their butt allowing billion dollar mega corporations to have their way. So why bother to hire regulators to maintain the pretense.
If we have free market capitalism, then the Medicare drug benefits program that resulted in Big Pharma and HMOs raking in profits hand over fist needs to be repealed and generic drugs and drugs from other countries over the internet need to have equal participation. Ge whiz, that would be COMPETIOTION for a change. Isn't that a part of how Adam Smith described as free market capitalism?
They should outlaw corporations paying doctors to use their products.
To answer the question in the title of the article:
When pigs fly and enough "important" people die.
Poet
A comprehensive single payer health insurance system will solve the problems addressed in this article. It will also level the playing field for US business (not just GM, Ford and Chrysler) to compete globally. This is both a health issue and an economic recovery issue.
Tell your congressman to co-sponsor Rep. Conyers HR 676 single-payer bill. Tell your US Senators to introduce a companion bill in the US Senate.
Mitch the Bitch daniels and Tom Tom Dashcund in Bed together.
Cool
Love
Zero
How about totally deregulating stevia and allowing manufacturers to use that for a change? Let stevia compete with high fructose corn syrup and aspartame as those two are long term health hazards. Where are the "libertarians" when you need them on this issue? I guess they "love" big government as long as it's a puppet to select corporate interests. ABOLISH THE FDA !!!
The same simplistic dualities and the same old game of framing of "the problem" is, once again, in evidence here. Let's try looking at this from a different angle:
"Advertising expenditures for broadcast TV totaled $46 billion in 2004. Pushing products and services while we experience difficulty concentrating is what TV is all about. Critical thinking on the consumer's part is detested in the corporate world, because if we were given the opportunity to evaluate products and services, we probably wouldn't buy most of them. TV is the ultimate corporate brainwashing tool. The network shows are so lousy (on purpose) that we salivate when the slick advertisements come dancing across the screen. Of course we want those magic pills!
I estimate that 80% of the prescription drugs currently sold in the marketplace are either useless or downright harmful. Some are necessary to alleviate the problems that were caused by previously prescribed medications. Over 3 billion drug prescriptions, worth $221 billion, were sold in 2004 - an average of 11 prescriptions for every man, woman and child in the United States.
In comparison, $190 billion worth of retail clothing was sold in that same year. (Source: The U.S. Census Bureau's Statistical Abstract of the United States, 2006)
We may as well admit the truth: The Food and Drug Administration and the American Medical Association are in bed with the drug companies. Food, shelter, clothing, sex and drugs are the bare essentials for survival in the 21st century, as we hip-hop our merry way through direct-to-consumer ads."
Magarulian, February 2007.
"Disease mongering is the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments. It is exemplified most explicitly by many pharmaceutical industry-funded, disease-awareness campaigns - more often designed to sell drugs than to illuminate or to inform or educate about the prevention of illness or the maintenance of health."
Ray Moynihan & David Henry, 'The Fight against Disease Mongering: Generating Knowledge for Action' in the Public Library of Science - April 2006.
"Doctors should be criticized and penalized for using drugs and surgery when a change in diet and lifestyle would achieve similar or even better medical outcomes."
John McDougall, MD.
The FDA has tried more than once to restrict sales of vitamins and supplements, claiming that they are not effective and may be dangerous. They assume that only drugs can be used to fight disease.
Although they talk about the five-a-day for fruits and vegetables, they are not concerned with the quality of food or additives.
The Center for Science in the Public Interest:
http://www.cspinet.org/
has a variety of useful information. For example, click on "Food Safety" and for there on "Food Additives". There is a comprehensive list of additives with information on their safely.
Sioux Rose
MAGARULIAN: Incredibly right-on post! Excellent job!
Some excellent comments above!
Please don't miss Donna Smiths excellet aricle...http://www.commondreams.org/view/2009/01/30-5#comment-1126265
Its titled "Cognitive Dissonance"
"A test case for the new government will be how it deals with the pharmaceutical industry, which rivals the gun manufacturers and tobacco companies for the position of most amoral industry in America. "
- nobody is forcing guns into the hands of criminals, the gun industry doesn't even advertise on television. This is another case of a writer reaching way beyond the topic.
I see no letup however, in advertising for 'restless leg syndrome,' erections lasting more than 4 hours and my favorite - Zoloft, which claims that if you're feeling 'blue' for more than 2 weeks, you're clinically depressed and need their cure.
please.
So long as the government can rake in revenue garnered by big pharma and their ploys, there's no way any administration would kill this cash cow. Moreover, so long as Americans seek quick fixes to temporary ailments and 'depression,' the industry and its bullshit will thrive long after most of us are dead.
I love my country and most ... of my countrymen and women, but lets face it, Americans as a whole are weak-willed, self serving whiners who demand instant gratification for everything. Feeling sad? Take a pill! Can't get it up? Take a pill! Got the jitters? take a pill! No motivation? take a pill!
We've become so immersed in ourselves and our own failings that entire industries have risen to do what good corporations do - PROFIT off of the newly created market.
I know, Im going to be deemed insensitive, but I don't care. I am sick of people demanding to be protected from themselves and then blaming their failings on 'evil' corporations. Does big pharma suck? YES! Shit, the Medellin cartel could only DREAM of such brand loyalty.
'Yes I'm an extremist, thanks for noticing.'
- Ted Nugent