Another point concerning the MedWatch reports not mentioned is that there is no uniformed terminology for reporting a specific side effect. For example in the Wellbutrin SR MedWatch for November, 1997-Febuary, 2003 heart attacks are listed as myocardial infarction (192), cardiac arrest (110), cardiac failure congestive (31), cardiac failure (27), cardio-respiratory arrest (27), cardiac arrest neonatal (1).
Individually, these numbers may not be considered as shocking, but when totaled (388), a new picture of the drug does emerge.
Is this a deliberate attempt to obscure the numbers, and if not, then why is the problem of non-uniformity not being addressed? By having a set guideline of terminology and reporting methods, more accurate numbers would be available for review.
Also, though included in the online published interview with Dr. Lutwak, one thing that your televised report failed to mention was that many of these drugs' number one reactions are psychiatric/neurological disorders including anxiety, panic, mania, mood swings, and depression. In some, these can be permanent.
One issue that was lost or understated was the very difficult position FDA is in when approving a drug - with data on "only" a few thousand individuals they have to decide whether the drug is safe and effective in what will ultimately be a patient population of hundreds of thousands or millions of patients.
The post-approval reporting system for adverse events is poor and needs fixing - one key element is a requirement that physicians report events they consider related to drug. This is required for vaccines, but no other drugs. A mandatory surveillance system would improve the safety of drugs. A huge political issue will be paying for it, and adding regulatory requirements to physician practice.
One small data point that was missed, and might have made for an interesting discussion. Since 1997 the percentage of post-approval adverse events reported to FDA that are considered "Serious" and "Unexpected" has risen dramatically. I've yet to hear a good explanation! (See http://www.fda.gov/cder/present/raps10-2002/juliebeitz/sld008.htm for reference)
I look forward to a follow-up. There are many issues in the industry that could be explored: how many good drugs don't get developed because of artificial barriers (e.g. market, regulation, etc.)?; the exodus of experienced scientists from FDA; the lack of regulation of dietary supplements; etc.
While I appreciate your efforts, a word of caution. I've had RA for 25 years. For most of that time, the FDA has been so afraid to pass new meds that I was sometimes left with nothing that worked. Please don't scare them back into that hole. If they are looking at a drug for baldness, then they should be cautious. But, for disorders that ruin people's lives, take a chance.
I'm taking Arava now (along with Humira and others) and won't stop because a few people died from it. I'll take my chances because living without the drugs is hell on earth and death looks good in comparison. You probably cannot imagine what it's like when the water from the showerhead hurts, when a single sheet on top of you hurts, when you can't get the toothpaste out of the tube, when you can't cut up the food on your plate, or chew it if someone else cuts it up for you. I can and I don't want to experience that again.
If you want to make people safer, restrict the use of risky meds to specialists but don't take them off the market. Many problems come from doctors using drugs that they are not really familiar with. As the AMA will never go along with any restrictions, please, leave medications for RA and other serious illnesses out of your fight with the FDA. Some of us need the options at any risk.
As usual the consumer gets the fatal dose of reality. I have always been in favor of a bigger government that protects us the citizen. Strong agencyís to ensure our food supply, the habitat of our environment, the security of property and life, civil liberties and remedies for health and safety. Unfortunately our politicians have become the voice of our commercial culture while the dedicated experience people of our government go silent at the peril of fear and back home to citizenry where we the people wake to another day of shaded truth.
Government inoculated by the clout of political anxiety is toxic. Politicians inoculated by the dollars of industry are habitual addicts. Thank heaven for Frontline, thanks for doing what my elected representatives wonít.
Thank you, Frontline producers and staff, for providing one of the most valuable news shows on television today. I can not remember when I was more personally affected by a documentary than I was by "Dangerous Prescription".
My Mother was the victim of sloppy prescribing practices and inadequate warnings about the interaction between prescription drugs that almost cost her her life. Keep tackling the tough stuff...you're up to the task.
I don't see how the financial connection between the FDA and the pharms can cause the corruption evident in your report. What, financially, does the FDA lose as a result of rejecting a drug? If the answer is "nothing", then there is no motive for pushing a dangerous ineffective drug through the approval process.
It seems nearly certain that the corruption occurs through other means, either through political pressure or from direct ties between the advisory board members and the drug companies.
I wish the FrontLine report had studied in more detail the cause of the corruption.
Quality control for health care is not some unmanageable monster. With information contained in doctor's files our current Information and Communications Technology could automatically audit the outcomes of care to 1) determine efficacy of drugs, surgeries, doctor management of patient care, and hospital services, not just for research purposes but for ongoing care (with numbers of items in the billions per year, 2) provide the necessary information to allocate health care resources most efficiently, and optimize the quality/cost of health care, and 3) create invaluable quality and cost based competition in the health care industry by giving patients and insurers the outcome info they need in summary form and in patient terminology to make the best care choices at reasonable cost.
Such an Outcomes Analysis System could allow the earliest possible valid evaluation of treatment efficacy in practical use. That would eliminate long delays a) before discovery and elimination of destructive causes such as "net loss" health care treatments (surely in the high hundreds of thousands every year) and malpractice (80,000 deaths per year and hundreds of thousands of disabilities), and b) before discovery of invaluable new treatments (e.g., antibiotics discovered by chance in the early 80's as a cure for 85 percent of peptic ulcers). Like the FDA staff stumbling onto far too few very important things via the FDA feedback system, an Australian doctor happened to find a set of patient records before him that showed an unexplained cure of patients he treated with antibiotics for other reasons. Any reasonably well conceived analytical outcome system for care would have found that correlation years earlier thus preventing useless treatment cost, pain, lost time, and suffering for millions of patients.
I appreciate the value of Frontline's report. However, reporting about the tail of the health care quality control elephant separate from the whole elephant leaves us with no reason to think of an Outcome Anaysis System solution that only becomes feasible when it deals with the entire elephant. Every aspect of health care needs quality control. The size and complexity of the problem demands that we use automated statistical systems to correlate health outcomes with their causes. A complete system to serve all users will easily justify its cost with a tiny fraction of the savings in the amount of treatment required. However, the system can provide ancillary payoffs too - research data on full populations rather than inadequate biased samples; help doctors recognize, train for and move toward their strengths; save unnecessary and preventable treatment time and recovery losses; permit full coverage insurance by removing motivations to overuse; and provide resources for coverage on the large now uncovered or partially covered population of Americans.
I don't plan to send this to any other potentially interested entity. In your role as a strong public service medium, you have the means and the obligation to study and present the big picture so the public can pressure the powers-that-be for effective action. Only then can we expect to gather and analyze the data needed to well manage the U.S. health care behemoth which now directly absorbs 15 percent (roughly 900 billion dollars per annum) of our GDP and wastes an estimated 350 billion of it.
Frontline, please follow up on this story. The commercial networks have failed to expose the scandals in the medical and drug industries, in large part because of the huge advertising of drugs on TV. I have read that more money is spent on drug advertising on TV than for all other products combined.
I am horrified by tonight's report, but puzzled by the assertion that FDA is "influenced" by the fees paid by the drug companies. Those companies have no choice whether to pay. It is required by law. How could a drug company punish the FDA for failing to approve a drug? By not developing new drugs? It would not profit by that. And why do FDA scientists tamely submit to bullying?
I think there must be more to this story than I have heard. Could it be that political campaign contributions bring congressional pressure against FDA?
A second comment: How wonderful that the federal government tries to protect us from Canadian drugs, which do not go through such rigorous tests of their safety and efficacy!!!!!
GORDON E. PARKS
Frontline's "Dangerous Prescription" program hit one nail on the head, but turned the hammer wrongly toward the PDUF system as the cause of the problems. Certainly, the FDA is woefully under-resourced to properly use the MedWatch program, but the culprit for the slow/inadequate response to adverse safety information lies neither within the Agency nor with the drug industry.
The tidal change toward speedier approvals at FDA was not brought about by the infusion of PDUF money, but rather PDUF was a politically expedient response to horrendusly slow reviews at FDA. PDUF was simply a source of funds for more reviewers that didn't require Congress to commit the political suicide of direct tax money. The drug industry had deep enough pockets to pay PDUF rather than have new drugs wait uselessly in the FDA review queue. So the bargain was struck.
I have spent over 30 years of my life working under FDA regulation, and have always felt that companies could sway FDA only by data and scientific facts. FDA does, however, respond to political pressure from Congress that in turn comes from industry and consumer lobbies.
The underlying cause of the safety concerns presented in your program is the failure of Congress to provide sufficient funding for the FDA, while holding them accountable to do the impossible with nothing. That is the prescription for failure in any system.
Only Congress can make the reporting of drug safety concerns mandatory; only Congress can provide sufficient funds for those reports to get proper review and analysis at FDA; and only Congress can resolve the societal issues about the costs and availability of prescription drugs. The prescription for us as voters is to get representatives in Congress who will tackle these issues.
The health insurance industry is also to blame for some adverse drug reactions when they require patients to switch between drugs of the same therapeutic class based on price only. Because of each patientís unique genetic make up, these drugs cannot be assumed to have equal toxicity and efficacy in any individual. There is no reason a patient should have to switch from a drug, e.g. Lipitor, that was working well without side effects to a new statin, e.g. Baycol, with no therapeutic upside and the potential for new side-effects.
Bruce Bostrom, MD
Saint Paul, MN
I'm appalled at the way the FDA is so obviously influenced by the Pharmiceutical Industry! As an employee of the Airline industry I see the similarities between how "Big Business" forces it's will by pressure and funding!
The FAA has neglected security in the past because its mandate was more likely to lean towards airline profits instead of saftey! The NTSB does a great job as an independent agency investigating Aircraft misshaps, but too often the FAA has neglected to follow the NTSB's recommendations.
I really doubt that any sort of independent agency that would follow up the FDA's approvals could make much of a difference as long as the FDA continues to receive money from pharmiceutical companys.
Having worked as a RN 44 years, I am frightened of traditional drugs. They cause many more illnesses than they cure but as your data showed, the info is suppressed. I and my loved ones take vitamins and minerals, herbs to ward off diseases. Thank you for your program, please keep them coming, the public needs to be informed.
This boycott of cheaper drugs from Canada is a disgrace, folks should not have to sell their homes to buy drugs. Our country is being blinded by all the drug advertising etc. scare tactics being used to cause people to seek drugs to keep from having heart attacks, strokes, etc. I had no idea much of the money funding the FDA comes from drug companies - amazing and disheartening.
st. louis, mo
I do not feel the FDA is doing a very good job. In fact I feel that the big Pharma's money is contributing to this poor job. When it takes thousands of injured americans telling Medwatch of their problems with a drug and the FDA sits on its hands and does nothing, something stinks not in Denmark but at the FDA.
I along with many people I know are suffering from Lipitor and all have reported it to Medwatch. One great article appeared in the November issue of Smart Money. A great link to message boards made up of many Lipitor injured is www.ditonline.com
We are having to live with neuropathy, muscle cramps and memory loss but no one wants to hear our story. What is it going to take for someone to listen to us. At the rate they are pushing this drug we are going to have a whole country of disabled from that one drug. Please someone hear us out.
winter haven, florida
The program missed the most important factor: political corruption. Drug companies give millions of dollars to politicians, who then pressure the FDA not to upset the drug companies. Any FDA official who threatened pharmaceutical profits, and political "contributions," would lose his job. Your elected representatives are responsible for this situation.
Salt Lake City, Utah