Sooooo… the FDA says it doesn’t inspect drugs imported from China and India (and sold through U.S. pharmacies) for safety. Did you know that almost 80 percent of the active ingredients in prescription drugs sold in the U.S. come from these countries?
And yet, the FDA still wastes its time with the “issue” of U.S. consumers buying drugs from licensed Canadian pharmacies. Something doesn’t quite add up, does it?
Watch the Lou Dobbs report:
The FDA is considering allowing consumers to purchase some medications after consulting with a pharmacist — but without a doctor’s prescription. The creation of this “behind the counter” class of drugs would be a welcome relief for patients who don’t have the time or, in many cases, the money for frequent doctor’s visits — particularly simply to get prescription refills for chronic or long-term conditions. Many other developed countries already have such a class of medications.
Thanks to new legislation soon to be signed by President Bush, the scandal-rocked FDA will have a host of new powers designed to enable them to better regulate prescription meds. Here is a quick summary from OnPharma:
-Order warnings on drug labels
-Review drug ads before they air on television
-Make results of drug clinical trials available publicly
-Reduce the number of expert advisers with industry ties
-Require studies of new drugs’ performance
-Probe patient databases for early signs of side effects
Although I like the idea of fewer doctors with industry ties, the underlying premise of Big Pharma funding the FDA’s oversight seems like the biggest conflict of interest of them all. According to Scott’s Web Log,
The Food and Drug Administration (FDA) has become too cozy with the industry it regulates, and it looks like that problem is likely to get worse … [Big Pharma] user fees help fund the FDA along with some TINY annual appropriations from Congress …The FDA user fees were created in the early 1990′s as temporary means to fund the Agency, but has instead become the primary means of funding the government Agency who is supposed to be looking out for our safety. Our lawmakers should only be considering proposals to extend current user fees by a short time, not making it a permanent source of funding.
If you’re like me, you’ve had it with the FDA’s lax enforcement of Big Pharma on safety issues. It’s time to write your Congressperson about it:
U.S.PIRG, the federation of state Public Interest Research Groups (PIRGs), has put together an online petition for you to sign. The petition states:
Dear Chairman Edward Kennedy, Chairman John Dingell, Ranking Member Michael Enzi, Ranking Member Joe Barton:
Please include in the final FDA reform bill the strongest drug safety language possible. This will protect consumers from dangerous and deadly prescription drugs such as Vioxx.
The final bill should contain the House language to publicize clinical studies conducted on drugs so that doctors, researchers and patients know of potentially harmful side effects. It should also contain the House’s tough conflict of interest rules that apply to advisors of the Food & Drug Administration.
Your voice demands to be heard.
Since the rule change in 1996 that allowed Big Pharma to begin advertising directly to consumers, drug advertising budgets have exploded — while policing of such ads for accuracy has steadily declined, according to a study in the New England Journal of Medicine.
The thing I find most troubling about the report is that even though we have far more drug commercials now than in 1996, fewer drug companies have been reprimanded for their ads. In 1996, 142 warning letters were sent out by the FDA. Last year, there were only 21. Either the drug companies are making flawless ads, or someone isn’t doing their job. Which do you think it is?
From HealthDay News:
The widely used but controversial diabetes drug Avandia will now have a strong “black box” warning on its label, advising users of an increased risk of heart failure, the U.S. Food and Drug Administration announced late Tuesday. Another four diabetes drugs from the same class, including Actos, will also carry a similar black-box message, which is the agency’s strongest label warning. The FDA and the drug manufacturers, GlaxoSmithKline and Takeda Pharmaceuticals, have been negotiating the label changes since May.
Studies have suggested that Avandia (rosiglitazone), made by Glaxo, and Actos (pioglitazone), made by Takeda, raise patients’ odds for heart failure. Other research has suggested that Avandia might possibly raise users’ risk for heart attack, though the FDA has said that more investigation on that issue is needed.
“Under FDA’s post-marketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information,” Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.
How about a little PRE-marketing surveillance, FDA?
From the LA Times:
Dying people do not have the right to obtain unapproved drugs that are potentially lifesaving, even if their doctors say the treatment offers the best hope for survival, a U.S. appeals court in Washington ruled Tuesday. In an 8-2 decision, the court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.
Food and Drug Administration approval of drugs generally requires testing that can involve years of trials and thousands of patients. The families of terminally ill patients, several of whom died after they were denied promising drugs still being tested, filed the lawsuit. They said dying patients were far more willing to take risks and should not be forced to wait for new treatments to win final FDA OK.
Why not let people who are terminally ill use potentially life saving drugs — what’s the worst that could happen? They have nothing to lose and everything to gain.
More background on this issue here.
Maggie Mahar, author of Money-Driven Medicine: The Real Reason Health Care Costs So Much, argues at TPMCafe that our “me”-oriented healthcare system makes it difficult to permit terminal patients to purchase potentially life-saving drugs that have not yet been approved by the FDA.
Writes Mahar:
A recent study shows that fully 42% of the products that make it to the third, and final phase of FDA trials ultimately fail because they prove ineffective and/or unsafe.
How do so many lemons get so far? The study suggests that once a drug company has invested a certain amount of money—and reserachers have invested a certain amount of time and ego—it becomes difficult to admit failure. Moreover, as long as investors think a drugmaker has a new product in the pipeline, the stock will stay afloat.
Meanwhile, Wall Street hype about a “life-saving drug” tends to spill over into the media where it fans faith in the miracle drug, a phenomenon I’ve written about here in a story about a prostate cancer vaccine…
So physicians … have reason to fear that if patients could buy the drug, it could become difficult to mount the full-scale randomized trials needed to establish firm evidence of a drug’s efficacy and safety.
If drug-makers are allowed to sell experimental products at a profit, who will buy cancer drugs at $50,000 a pop? Wealthy patients. Others will have to wait for FDA approval.
Meanwhile, if an individual who uses the drug outside of carefully monitored trials dies, there is a real risk, as a drugmaker in this WSJ story points out, that the FDA will halt randomized trials until the company can investigate what happened. This means more delay for the less affluent.
In the end, the questions the debate raises remind me of the point Michael Moore made in “Sickoâ€: In other countries, people think about healthcare collectively, in terms of “we.†In the U.S. we think of healthcare individually—in terms of “me.†This is one reason why our heatlhcare system is broken.
From Forbes.com:
The U.S. Congress is poised to pass a bill that would give the U.S. Food and Drug Administration the authority to regulate tobacco. But experts are divided on whether the bill will have significant impact on tobacco use, a habit that kills some 436,000 Americans a year — nearly one in five deaths annually.
Identical bills in the House of Representatives and the Senate would grant the FDA the same authority over tobacco that it has over drugs, medical devices and many foods. The bill would allow the agency, which has come under fire in recent years for its monitoring of the drug industry, to regulate the levels of tar, nicotine and other harmful ingredients in cigarettes and smoke. That smoke contains some 4,000 chemicals, more than 40 of which are known to cause cancer.
This would be the biggest boon for Big Tobacco since Joe Camel. Let’s pray it never happens.
It appears someone finally decided to take a look at the effectiveness and benefits of older diabetes drugs (such as metformin) compared with newer, more expensive ones (such as Avandia). Dr. Shari Bolen of Johns Hopkins University studied various medical databases and found 216 relevant studies and two systematic reviews. According to Reuters:
Older drugs controlled blood sugar levels about as well as the thiazolidinediones [Avandia] did. There were some differences, however, in other effects.
Thiazolidinediones were the only drugs that increased HDL “good” cholesterol levels, but they also increased LDL “bad” cholesterol levels. Metformin reduced LDL cholesterol levels, while the other agents appeared to have no effect on cholesterol levels.
With the exception of metformin, the drugs generally increased body weight by 1 to 5 kilograms. Compared with other drugs, sulfonylureas and repaglinide were tied to increased risks of low blood sugar, thiazolidinediones were linked to heart failure, and metformin raised the risk of stomach and intestinal problems.
“Each oral diabetes agent is associated with adverse events that counterbalance its benefits,” the researchers conclude. “Overall, metformin seemed to have the best profile of benefit to risk.”
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Cary Byrd, President of eDrugSearch.com
