Are The Drug Companies Pushing Too Hard, Or Is The FDA Not Doing Its Job?
Drug companies push new products really hard. Just before Prozac became available in generic form, meaning Eli Lilly and Company was losing its patent on it, they developed a slow release, once-a-week version so they could still market the drug (one of the most popular for depression) under a patent and make a mint on it. My doctor told me that the Eli Lilly reps offered all-expenses-paid trips to doctors who could successfully move patients from the daily (which was going generic, and thus quite inexpensive) to the new patented version. In his office, which is quite large, the "target" to get yourself a trip was successfully moving 100 patients over to the weekly product. I asked him if that was a challenge, and he said that in a large practice like his, it really isn't. He's one of the partners in the practice, and he said he could easily, with almost no effort, have moved that many patients to the weekly if he had wanted to. He didn't want to, because he's not convinced the mechanism is quite as effective at treating depression as a daily drug is. Despite that, other doctors in his practice pushed the new drug, and went on trips.
It seems drug companies are very interested in pushing their new drugs--new patients with prescriptions in hand mean money in their pockets. But there's a catch with moving so fast. Here's an example:
Different drug, same problem. Bextra was pushed so hard I had it offered to me for an amazing array of things. It was first offered to me for menstrual pain the month after it came on the market. It was offered again and again for various pains, and when my main pain problem was diagnosed as fibromyalgia, that was the only drug the rheumatologist would consider giving me. Luckily for me, it never worked for me, so I never took it for more than two weeks.
Which leads to my main question. Who is responsible for these drugs which can cause long term damage and problems? Is it the drug companies who are required to do testing before the FDA will approve the drug for patient use? Are they not being careful enough in their testing by not testing for long-term effects? Or is it the FDA, for not forcing more stringent testing requirements?
I have several friends who rode the Phen-Fen train, and ended up with heart damage. I have a friend whose mother had a debilitating stroke after taking Vioxx for just six months. And I know more than one person who attempted suicide as a teen after they were given second-generation depression drugs like Zoloft and Paxil. (One actually has a sibling who was given the same drug and did commit suicide.) Those drugs are now labeled as having increased risk for teens and kids.
So, who's to blame? And what can consumers do when doctors are generally so eager to prescribe the newest medicines, which may not be safe?
I'd love to hear your thoughts.
Thank you.
Ṟ..2008-10-14T05:21:24Z
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The whole area of doctor-patient and doctor-drug company relationships is a moral minefield. The reality is that in a doctor-patient relationship the doctor has the real power, and for many people his recommendation is followed unquestioningly. Any doctor who prescribes drugs to a patient on the basis of reward from a drug company is clearly in breach of his Hippocratic oath, and should be treated accordingly. In many cases doctors may well genuinely believe, or want to believe, the literature from the drugs companies, and, being unable to personally verify the claims, simply take them on trust.
Perhaps the simple answer would be to make it illegal for doctors to take any form of remuneration from drug companies, or their agents, but this could be difficult to police; how do you determine if a foreign 'conference' is legitimate or a 'jolly'. Another idea is to make doctors who take payments or gifts in some way legally responsible for side effects of such medication, but this would probably be all but impossible to frame in any totally fair and meaningful legislation.
On the other hand we shouldn't forget that patients are often too keen to try new medication, even if unproven, when they are unhappy with that currently prescribed. It can't be easy for doctors, or for the regulatory and test authorities, to balance the potential benefits, costs and possible side effects, particularly when some side-effects may be rare and take many years to identify. Patients often have quite unrealistic expectations of the medical profession, and either conveniently ignore warnings of possible side-effects or assume/hope it won't apply to them.
Perhaps the only real answer is education, isn't it always! The more people are made aware that they own the responsibility for their own health the better. They should ask more questions, make themselves better informed about their health issues, and if their doctor proposes a novel new medication perhaps even ask if the drug company is 'promoting' it, and then perhaps the relationship with their doctor will become more equal.
So, who's to blame? Ultimately it's us, the patients, we have unrealistic expectations, don't make the effort to inform ourselves, don't ask enough questions, and if it goes wrong we want to blame someone else. However, we should attempt to stop the flow of money from drug companies to general practitioners and practice managements by legislation.
Bottom line, you can't generalize all doctors or drug companies. Yes, some doctors will prescribe medications that they are heavily marketed to, but I don't think that is the norm. My fiancee is a doctor (OB/GYN) and she prescribes medications, birth control, etc. based on the specific needs of her patients. I know a fair number of doctors, and they all follow prudent guidelines when prescribing. Of course, not all doctors act that way and are essentially the drug companies lackeys. I feel this is true of any industry, however. Let's not forget that in America, health-care is a commodity. Could the FDA be doing a better job? Absolutely! Is it their "fault", not necessarily. While I am very saddened by our health-care system, the US still offers the greatest choice of doctors and medications in the world. Like any other business, I feel that the consumer, e.g. patient, needs to inform themselves and research any Rx's that a doctor wants to give them. Too many people tacitly accept what their doctor's say as fact instead of finding out themselves. So, there is blame to go around the table. Doctors can be the culprit sometimes, drug companies can be, but people are also complacent. This is yet another reason why we need sweeping reforms in the whole health-care system in the US.
I've enjoyed reading your responses thus far!!!! Sadly at this point I feel we are to blame...for not taking responsibility for our own health and availing ourselves of the world of Information out there on how to remain healthy and how to treat ourselves naturally. There is also plenty of information out there that details the collusion between the FDA and the pharmaceutical companies. Kevin Trudeau has written several good books where he talks in depth about this issue. The FDA cannot be trusted. Their first responsibility is protect and serve their own vested interests..BIG PHARMA!!! One area where this is especially devastating is the area of psychiatric drugs. Most of them have devastating side effects and do very little in the way of true help for the conditions they supposedly "treat". I am a classically trained nurse but my interests lie totally in alternative and holistic medicine that address body mind and spirit through proper diet, the use of herbs and the exploration of self. I would not take any drug before thoroughly researching both it and my "condition" to try to figure out how I got there in the first place. I know most people without a health care background don't know how to do that but things are changing and more and more people are starting to question and demand more of their doctors than just having them write a prescription. Many are even adding naturopathic doctors to their list of medical experts!! I could go on and on... Thanks for the question!!
This is a question that could take a month to answer! You can make an incredibly strong case against doctors, pharmaceutical companies and the FDA. There is plenty of blame to go around, but I'm particularly bothered by the FDA.
Our beloved watchdog is notorious for putting the welfare of pharmaceutical companies well ahead of that of the patient. Last year, Public Citizen, a national non-profit public interest organization, exposed that conflicts of interest at the FDA's drug advisory committees finding it to be incredible common. Small wonder that many FDA members have greatly benefited from this sordid association, retiring with cushy jobs and plenty of financial perks.
It would take a month to list just half of the injustices, but I will site a few examples:
1.This latest decision by the FDA to keep Avandia on the market, knowing full well that it will kill thousands of Americans each year. There rationale: [there are other drugs on the market that also can potential kill. Avandia is not worst]
2. Following the death of as many as 60,000 Americans from COX-2 inhibitors (source: British Medical Journal, author Dr. David Graham, FDA drug safety researcher), an FDA advisory panel has now voted to allow the drugs to return to the market with full FDA safety approval. Of note one COX-2 drug has been reported to have killed more Americans than died in Vietnam.
3. FDA openly allowed marketing of dangerous cold medicines to infants and children well before it became public knowledge that there medications were potentially quite harmful to anyone under 6 years old.
FDA's reluctance to pull obviously dangerous drugs off the market in a timely fashion (Rezulin, for example), with the FDA's attempts to silence its own drug safety scientists (censorship of Dr. David Graham, for example), and with the FDA's collusion with drug companies in suppressing clinical trials and other forms of evidence that raise safety questions about prescription drugs, it is painfully obvious that corruption runs deep at the FDA.
Meanwhile they have been on a witchhunt for years, devoting much of there limited resources to erradicating BIGPharm's competition- the health food industry.
There is plenty of good work the FDA could be doing. There job is essential. If only they would do it!
This is an interesting discussion. Perhaps a great place to ask your question would be 'Ask AP' which is asking a reporter from Associated Press, who is supposed to research your question and supply you with an educated answer and potentially publish your question along with his answer. You can also write your Senator or Congressman as this has been a topic of peaked interest and argument for years. In this time of corruption, it does make one suspect the FDA may well be receiving kickbacks from the drug companies along with the doctors, although I would hope this is not the case.