The US Government Accountability Office GAO has used pharmaceutical consultants to look into people working for the FDA and the results are a damning criticism that the Food and Drug Administration hires criminally convicted doctors to work for it in clinical trials. By failing to debar anyone with a criminal record from work activities with the FDA, the Administration is breaking its own rules.
It takes the FDA an average of four years to debar anyone working for them with a criminal conviction as shown in the results of the GAO enquiry. This is sensational when you consider that the FDA is required by law to disqualify any doctor who has been criminally charged in the past. In one case it took the FDA 11 years to disqualify a doctor who had been convicted of 53 charges including covering up a patient’s suicide during a clinical trial.
Prescribing medicine without a license, fraud and lying during clinical trials were other charges that doctors had been committed of. There are even three doctors who continue to work with the FDA despite knowledge that each of them have a criminal conviction.
One of the main charges that the doctors had been found guilty of was falsifying clinical trial data. They made up statistics for non-existent participants, did not follow the research plan of the trial or failed to gain the informed consent of trial participants. There is also a contentious issue over doctors who have been found to break the law over medical devices. At present there are no laws to prevent doctors barred from medicine to work in the medical device industry which means that they could be endangering the lives of millions of people, like asthma sufferers.
With the FDA already breaking rules and laws with no regard for the consequences, there seems little point in simply applying new regulations. Instead, they propose a wide reform of the whole health care system in America. Prosecutions for doctors found to be breaking the law, company executives barred from senior roles in the FDA and a stricter relationship between the FDA and drug companies.
Posted by admin under
Health and Fitness
The pharmaceutical consultants at the US Government Accountability Office (GAO) has criticised the Food and Drug Administration for allowing doctors and researchers with criminal convictions to work for the FDA as supervisors during clinical trials or as researchers. By failing to debar anyone with a criminal record from work activities with the FDA, the Administration is breaking its own rules.
GAO officials have publicised their records which show that it takes the FDA an average of four years to debar convicted medical practitioners from working with them. And this comes even though the FDA are required by law to immediately disqualify any doctor who has been charged with fraud or any other type of crime. One dramatic case was that of a male doctor who had been convicted of a 53 criminal counts but went on to work for the FDA for 11 years.
Other cases involve medical professionals who have committed fraud or prescribed medicines without a license. Three doctors continue to work for the FDA even though they have public criminal conviction charges.
presenting false data at clinical trials was the dominant charge amongst the doctors. Participants were made up, they had their consent forced on them and some of the doctors failed to stick to the research plan entirely. There is major concern over criminal doctors’ involvement in the criminal device industry. Under present FDA rules, a doctor who has been convicted of a criminal offence is not prohibited from practicing in the medical device industry, which could be putting the lives of millions of people at risk, especially since inhalers used to treat asthma are thought of as a medical device.
Critics do not see any benefits of introducing new rules as the FDA has already flouted many of the laws that currently govern it. Instead, they propose a wide reform of the whole health care system in America. Proposals include that no company director should be allowed to hold a senior position within the FDA and those doctors who break the law should be prosecuted.
Posted by admin under
Health and Fitness
Pharmaceutical companies which manufacture and distribute medicines and medical devices must ensure that they comply with current Good Manufacturing Practices or cGMP. The whole aim of GMP is to ensure a high standard of drug entering the market. As technology improves and research comes up with new drugs there are new pieces of legislation brought into cGMP. Without GMP consulting it would be impossible for any pharmacy business to stay in line with cGMP.
A business has two choices; it can employ an in-house GMP consultant whose sole responsibility is to stay up to date with cGMP, or they can hire an independent consultant on a biannual basis. There are many factors which make the latter choice the better one.
The money you spend on an independent consultant is lower than the salary you would have to pay a full time employee. You will only need between two and four consultancy meetings per year unless there are major developments. If you were to permanently hire someone you are looking at an average salary of
Posted by admin under
Health and Fitness
Health care in the UK is bitter sweet. Free medical advice and treatment is excellent, especially when compared to pricey treatment in countries like America. However, we are often hard pressed to find a doctor that can see us when we need them, having to wait weeks for an appointment if we cannot get out of work. If you are struggling to get advice or treatment for any ailment, where else can you turn for your health needs? Now I am quite the hypochondriac, but going to the A&E room for anything other than an emergency is just plain silly. The proliferation of pharmacies on our high street should be where we are turning to, because the staff are superbly trained and can help 90% of people on the spot.
Pharmacists have the chance to become independent prescribers with the ability to prescribe licensed drugs from May 1 2006. Qualified personnel are called Pharmacist independent prescribers.
This system makes it much less of a hassle to get medical advice or a prescription for people living in the UK who cannot take time off work to visit the doctor. All you need to do is go into your local pharmacy and ask to speak to the pharmacist in charge. Just because you are not speaking to a doctor does not mean you will be able to scam the pharmacist into giving you unnecessary drugs. There will be thorough examinations before any drugs are prescribed, just as you would expect at your doctor’s surgery.
Before they are allowed to prescribe licensed drugs, pharmaceutical consultants will go through extensive training. Spotting for substance abuse and recognising symptoms is included in the training that independent prescribers will be given before they are qualified.
Your high street pharmacist should be your first contact with the health care system for minor and non-urgent medical issues. If you have a very serious problem or need urgent treatment, a pharmacist will refer you to a doctor or emergency department at your nearest hospital. This means you can be back to your normal self as quickly as possible.
Posted by admin under
Health and Fitness
In drug production, excipients are used to hold the active ingredient (API) and make the products easier to handle. This is important if the active ingredient (API) is extremely potent and needs to be given in an accurate dosage, or if the API needs to be mixed with the excipient so that it can be absorbed into the human body. Both oral tablets and rectal suppositories use excipients. Excipients are considered to be a trade secret as they can keep the API active and thus prolonging the shelf life of the medicine making it competitive on the market.
GMP consulting can be used as to the best colour, lubricant and flavourings among other factors to be added to the product in order to make it more effective and appealing. It can help you to distinguish your product from other competitors on the market and make your manufacturing processes more cost and waste effective.
Having a signature colour for your product can make it stand out from other drugs. It also makes it easier to identify your medicine by health care professionals and patients.
You can use flavourings to make your drugs taste better, like using a cherry flavouring in bitter products. You can also mask sour and salty flavours by using raspberry and apricots respectively.
Giving a longer shelf life to drugs is done by using preservatives. Synthetic preservatives like parabens can be used. If you want to use a natural substance, popular choices include vitamins A, E and C as well as citric acid.
Minerals like talc and fats such as vegetable fats are used as lubricants in tablets and hard gel capsules.They reduce waste by preventing ingredients from clumping together or sticking to the machinery.
Fillers make tablets and capsules easier for patients to handle and the manufacture process more practical. The ingredients used in fillers need to be pretty tasteless, compatible with the other ingredients in the medicine and relatively cheap.
These are just some of the factors that excipients need to fill.GMP consulting helps companies to decide which ingredients are best to use for them and make sure there is no over lapping with their competitors.This makes products safe for human use as well as competitive as tests are done to make sure the excipient ingredients are compatible with the API.
Posted by admin under
Health and Fitness