Lawmakers Ask DEA for Information Regarding Opioid Diversions

http://www.hstoday.us/briefings/daily-news-analysis/single-article/lawmakers-ask-dea-for-information-regarding-opioid-diversions/fb3475fa2556aef3e02c123f61ae91e2.html

Concerned about whether the Drug Enforcement Administration (DEA) is doing enough to investigate and prosecute the illicit diversion of opioids, Senate Committee on Homeland Security and Governmental Affairs Chairman Ron Johnson (R-WI) and ranking member Claire McCaskill (D-MO), this week sent a letter to DEA Acting Administrator Charles P. Rosenberg requesting information regarding anti-diversion investigations conducted by the agency since 2011 in the wake of the opioid crisis.

DEA is instrumental in preventing and investigating diversion of controlled pharmaceuticals from both government and private facilities.

The lawmakers said that, “In 2015, when the committee examined allegations of opioid abuse at a VA facility in Tomah, Wisconsin, we learned that the DEA had been investigating allegations of diversion relating to the facility since at least 2009. Two years after news broke of the tragedies—and eight years since the DEA began its investigation—we are unaware of any administrative or criminal charges stemming from the tragedies at the Tomah VA facility.”

The two lawmakers said, “According to news reports … DEA has also been slow to target private pharmaceutical distributors … for example, when DEA agents ‘began to target wholesale companies that distributed hundreds of millions of highly addictive pills to the corrupt pharmacies and pill mills that illegally sold the drugs for street use,’ DEA officials at headquarters ‘began delaying and blocking enforcement actions.’ The DEA has also reportedly provided ‘conflicting guidance’ to a pharmaceutical company about its responsibilities to report suspicious orders from retailers. The conflicting guidance reportedly contributed to the government’s inability to obtain criminal convictions following its investigation.”

“DEA officials [also] may have presented conflicting guidance to a pharmaceutical manufacturer concerning its obligation to know its ‘customers’ customers,” they stated, asking Rosenberg to “describe any obligations manufacturers hold to monitor and report suspicious activity by pharmacies and doctors, the sources for these obligations under law or DEA regulations, and any related guidance the DEA has provided to manufacturers.”

“As the chief federal law enforcement agency responsible for enforcing the nation’s drug laws, the DEA has a duty to investigate violations of controlled substance laws. Accordingly, we write to request information about the DEA’s practices with respect to enforcement actions in anti-diversion investigations,” the lawmakers wrote Rosenberg.

“To assist the committee in better understanding how the DEA has pursued anti-diversion investigations during the opioid epidemic, we respectfully request the following information and material:

For each year since Fiscal Year 2011, please provide the following data relating to the DEA’s anti-diversion activities:

• The number of civil case filings against distributors, manufacturers, pharmacies and doctors;

• The number of immediate licensure suspension orders or orders to show cause against distributors, manufacturers, pharmacies and doctors;

• The number of voluntary license surrenders by doctors, including the number of such surrenders related to DEA enforcement actions; and

• The number of administrative enforcement actions brought against opioid distributors and manufacturers.

For each entry, the lawmakers are seeking the identity of the entity, the date of the DEA’s action, the nature of the allegations and the disposition of the matter.

For each year since FY 2011, they’ve requested identification of all fines DEA has levied against distributors and manufacturers, including the amount, date and recipient of each fine.

For each year since FY 2011, they’ve asked DEA to provide a list of the number of reports to DEA from manufacturers and distributors concerning suspicious orders of pharmaceuticals, broken down by the individual manufacturer or distributor.

For each year since FY 2011, lawmakers also want all the following data relating to the DEA’s anti-diversion activities:

• The number of anti-diversion investigations relating to a Department of Veterans Affairs facility or doctor;

• The number of license suspensions or civil proceedings against a VA facility or doctor; and

• The number of criminal proceedings brought against a VA provider.

For each entry, they’ve also asked DEA to identify the relevant facility, date of the proceeding, the nature of the allegations and the disposition of the matter.

The lawmakers stated that “beginning in 2013, DEA attorneys ‘started requiring a higher standard of proof’ before civil cases could move forward. According to former officials, DEA leadership changed the burden of proof that investigators needed to meet before proceeding with administrative cases from a ‘preponderance of evidence’ to ‘beyond a reasonable doubt.’ Is this assertion accurate?  If so, please explain the reasoning behind this change and provide supporting material.”

And, “If accurate,” the lawmakers stated, they asked DEA to “explain whether [it] received approval or guidance from the Department of Justice, including the Office of the Deputy Attorney General, before requiring a higher standard of proof before proceeding with administrative cases.”

Continuing, the lawmakers stated, “As mentioned above, DEA officials may have presented conflicting guidance to a pharmaceutical manufacturer concerning its obligation to know its customers’ customers.’ Please describe any obligations manufacturers hold to monitor and report suspicious activity by pharmacies and doctors, the sources for these obligations under law or DEA regulations and any related guidance the DEA has provided to manufacturers.”

Finally, they wrote, “When investigating a VA facility or provider, please explain the process by which the DEA obtains investigative information from the VA. Has the DEA ever experienced difficulties obtaining information from the VA necessary to complete an investigation? Please explain.”

The lawmakers gave DEA “by no later than May 22, 2017” to respond, after which they said “the committee may seek a staff-level briefing at the appropriate time.”

As more and more are dying from illegally imported drugs from Mexico and China… lawmakers are concerned about diversion from legit distribution channels ?

This reminds me of a old joke…

This one person was walking down the sidewalk and saw this other person under a street light…walking around looking at the ground… as if they were looking for something .. maybe something that had been lost… the first person asked the person walking around under the street light if they had lost something… sure enough the person stated that they had lost a ring and was not able to find it… the first person asked exactly where they thought that they had dropped the ring.. and the person pointed down the street – which was completely dark… the sun had already set and there was no moon and there were no street lights down the street where the person indicated that they had lost the ring… the first person asked the “ring seeker” if they thought that they had lost the ring down the street .. why they were looking for the ring down on this part of the street… the ring seeker stated, rather matter of factually ,  that it was dark down the street and this is where the street light is… ???

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Mystery solved: Addiction medicine maker is secret funder of Kennedy-Gingrich group

www.statnews.com/2017/03/03/kennedy-gingrich-group-funder/

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company that sells a new opioid-addiction medication is a secret funder of an advocacy group fronted by Newt Gingrich and Patrick Kennedy that is pushing for more government funding and insurance coverage of such treatments.

Gingrich, the former Republican House speaker and a Trump confidant, and Kennedy, a former congressman and son of former US Senator Edward Kennedy, are paid advisors to Advocates for Opioid Recovery. They have generated a flurry of media attention in those roles, including joint interviews with outlets ranging from Fox News to the New Yorker.

Gingrich told STAT this week he didn’t know who was funding Advocates for Opioid Recovery, and the nonprofit group’s officials refused to disclose its financial backers.

The answer, according to a filing with the Securities and Exchange Commission, is Braeburn Pharmaceuticals Inc. The private company, based in Princeton, N.J., won approval last year to market an implant that continuously dispenses the opioid addiction medicine buprenorphine.

In a prospectus filed with the SEC in late January as part of a now-postponed effort to take the company public, Braeburn disclosed it entered into an agreement to make a $900,000 charitable donation to Advocates for Opioid Recovery. The filing indicates the company had paid $675,000 to the nonprofit group as of Sept. 30. It did not specify when the remaining funds would be paid.

The filing indicates Braeburn entered into the agreement to fund the nonprofit group through the private equity fund that owns the drugmaker.

That fund, called Apple Tree Partners, is also an investor in CleanSlate Addiction Treatment Centers. Kennedy has been a member of the board of directors of CleanSlate since 2015. The treatment center is also a sponsor of the Kennedy Forum, a mental health advocacy outfit headed by Patrick Kennedy.

Anne Woodbury, a former Gingrich aide who serves as executive director of Advocates for Opioid Recovery, did not immediately respond to a request for comment. A request for comment from Braeburn was also not immediately returned.

Kennedy declined to be interviewed this week, as did Van Jones, the CNN commentator and former Obama aide who is another paid adviser. Earlier this week, Woodbury and a spokesman for the nonprofit refused to say who was funding it, adding that the donors wanted to remain anonymous.

While there is widespread support in the treatment community for use of the medicines being promoted by the three men, there is growing concern about misuse of the drugs. And some addiction experts have expressed skepticism that the Braeburn implant will be an effective treatment option. There are alternative opioid-addiction treatments that do not rely on medication, including abstinence-based and behavioral therapy programs.

Last month, Braeburn shelved a planned initial public offering, citing poor market conditions. The company’s implant drug, branded as Probuphine, relies on four tiny rods implanted under the skin of the upper arm to dispense the addiction-treatment drug buprenorphine for six months at a time.

According to http://www.npr.org/sections/health-shots/2016/05/27/479755813/long-acting-opioid-treatment-could-be-available-in-a-month  The SIX MONTH therapy cost approx $5000.00 and the pt will now be dependent on a C-III medication… replacing their dependency on a C-II or C-I drug.

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Drug importation is dangerous

http://www.washingtonexaminer.com/drug-importation-is-dangerous/article/2622644

Like millions of Americans, I take allergy medicine. A few years ago, my doctor urged me to bid farewell to my local pharmacy and instead buy my medication from an online Canadian drug store, where it was cheaper. What terrible advice! The website was counterfeit and sent me “medicine” that was anything but — causing me to get severely sick for many months.

Millions of Americans could soon suffer the same fate. Congress is about to consider a bill that would make it legal for patients to import drugs from Canada. Lawmakers promise that the imports will be safe and effective. Unfortunately, that’s wishful thinking.

Let’s rewind. I started purchasing my allergy medicine online because it was cheaper. When the package arrived, nothing seemed amiss and the pills looked just like the ones from my local pharmacy. A few weeks after I started taking the new pills, I developed terrible migraines, stomachaches and gastrointestinal issues. I went to the doctor’s office, but no one could conclude what was wrong. After months of diagnostic work ups and a hospital visit, I still had no answers.

I began to suspect the pills themselves after hearing many online pharmacies provide counterfeit medication. I stopped taking them and as mysteriously as they had begun, my symptoms quickly disappeared. I went online to investigate whether anyone else had similar experiences. What I found was jarring.

The seemingly legitimate online pharmacy I used was operating illegally, and it wasn’t an exception. Over 96 percent of internet drug stores are illegal, according to a 2014 survey from the National Association of Boards of Pharmacy. Many don’t require a prescription. Some don’t even have a physical address.

Counterfeit drugs containing dangerous toxins — such as rat poison, lead and paint thinner — abound on these sites. The World Health Organization warned that over half the drugs sold by online pharmacies with either no physical address, or a fake physical address, are counterfeit.

These risks are precisely why the government has long banned drug imports. The Health and Human Services department admits it is unable to guarantee the safety of imports. The FDA has similarly warned that these foreign medicines pose great risks to patients.

Supporters of importation argue that the government could protect patients by only allowing imports from Canadian pharmacies. Yet many supposedly Canadian pharmacies traffic in counterfeits. The FDA periodically confiscates and examines illegal drug imports. Officials found that 69 percent of confiscated shipments contained unsafe drugs — and 80 percent of the shipments came from Canada.

Oftentimes, illegal online pharmacies claim to sell Canadian medicines, but actually obtain their drug supplies from unsafe developing countries. Even if the U.S. government tried to limit imports only to legitimate Canadian drug stores, many Americans would be fooled by extremely convincing imposter sites claiming to be Canadian.

If we open the door to widespread drug importation, I shudder to think how many patients will end up in the hospital — or worse. FDA officials and scientists are experts in their fields. They’ve repeatedly said legalizing imports would endanger patients.

I can only hope that Congress comes to its senses and listens to them. Better safe than sorry when it comes to our health.

Ali Schroer resides in Denver, Colorado.

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Woman’s skin ‘melts off’ after medication error

http://www.11alive.com/news/local/investigations/womans-skin-melts-off-after-medication-error/437871972

SNELLVILLE, Ga. — “I never lost anybody close to me, but that’s what it feels like.”

When 26-year-old Khaliah Shaw looks at pictures of herself from three years ago, she doesn’t recognize that person from before. Before her skin burned from the inside out. Before her sweat glands melted. Before the medically-induced coma. People can click this link here now if they need the best skin care routine. 

Before the mistake.

“I didn’t have to have people staring at me or wondering why I look different,” she said. “Three years ago, my life changed forever.”

In 2014, Shaw went to a doctor’s office because she felt depressed.  She received a prescription for lamotrigine. A pending lawsuit claims Shaw received the wrong dosage, and her pharmacy didn’t catch it.

For the first two weeks, “everything was ok.”

And then it wasn’t.

Blisters broke out all over her body. “I was in excruciating pain. It felt like I was on fire,” she said.

She was diagnosed with Stevens Johnson Syndrome a rare serious skin disorder. It’s usually caused by reaction to a medication or an incorrect dosage.

PHOTOS | Show progress of Stevens Johnson Syndrome

“It essentially causes your body to burn from the inside out and you pretty much just melt,” said Shaw.

The syndrome has left Shaw’s previously flawless skin burned and scarred. She is slowing losing her vision. Her sweat glands are gone, and her finger nails will never grow back. 

“This did not have to happen. This was not just some sort of fluke in my opinion. This happened as a directly result of somebody’s error,” said Shaw.  

An 11Alive investigation discovered those errors are happening at an alarming rate.

According to the Food and Drug and Drug Administration, errors jumped from 16,689 in 2010 to more than 93,930 in 2016. That’s a 462 percent increase. 

The numbers come from FAERS, or the FDA Adverse Event Reporting System (FAERS), a database that contains information on adverse event and medication error reports submitted to the agency. FAERS is a voluntary reporting system, so the numbers are likely higher.

The FDA says the spike is due to improvements made to its reporting system over the past two years. Pharmacy industry experts believe the numbers also reflect more people filling more prescriptions than ever.

Some experts believe there is something Georgia could do to reduce errors.

Matt Perri is a pharmacy professor at the University of Georgia. “When pharmacists get busier or pressure gets placed on the pharmacist, it makes it harder for them to do their jobs accurately,” he said.

To reduce errors, some states have tried to limit the number of prescriptions a pharmacist can fill to about 150 per shift. Georgia has no limits. Perri isn’t sure what the magic number would be, but he believes there could be benefits in setting limits.

“If you’re filling three or four hundred prescriptions by yourself, that’s clearly way too much for one pharmacist,” said Perri. “The idea of setting limits is unappealing on the business perspective, but on a patient safety perspective, it would be a good thing if we had a general idea of where those limits were.”

Jeff Lurey, with the Georgia Pharmacy Association, disagrees. “Patients come into the pharmacy at different times when they need to get medication filled. To put a restriction, I’m not so sure that’s in the best interest of our patients,” he said. “I’m just not convinced that cuts down on [medication] errors.”

Lurey argues training will have a bigger impact. This year, the association published a six-part training series focused on how pharmacists can reduced medication errors.

Perri’s advice for patients: make sure you’re consulted by a pharmacist. Georgia law mandates a pharmacist offer consultation when you pick a new prescription. Not a pharmacy tech, but an actual pharmacist.

Life after the mistake goes on. 

Shaw spent five weeks in medically induced coma while her skin slowly peeled off. There is no cure for Stevens Johnson Syndrome, and she could relapse.

“They’re telling me this could happen again, and they’re telling me if it did happen again, that it would be worse,” said Shaw.

According to the lawsuit filed on her behalf, medical bills have already reached more than $3.45 million. Extensive and prolonged medical care are expected to continue to add to those bills. 

Shaw is represented by two attorneys, Trent Speckhals and Robert Roll, both specialize in medication error litigation. 

“We continue to see the same errors over and over. [They’re] typically the result of pharmacists being too rushed, too busy, filling too many prescriptions and the use of [pharmacy] techs that really don’t have the training and the ability that a pharmacist would,” Speckhals said. “That’s one of the sad things, shocking things about it. It continues to happen at an alarming rate.”

“I never heard of Steven Johnson Syndrome until I was in the hospital with my skin melting off of my body. That’s when I learned what it was,” Shaw said. It’s a lesson she says no one should have to learn. “It’s important to know what’s in your body.”

“Be an advocate for yourself. Educate before you medicate,” she said. “Know what the side effects are.”

© 2017 WXIA-TV

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REP. JENKINS TO DEA: RE-EVALUATE OPIOID QUOTA SYSTEM

https://evanjenkins.house.gov/media-center/press-releases/rep-jenkins-dea-re-evaluate-opioid-quota-system

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You may be surprised how heroin makes its way into your community

http://www.cleveland19.com/story/35385436/you-may-be-surprised-how-heroin-makes-its-way-into-your-community

Apparently Bob Walling — a drug investigator with the Westshore Enforcement Bureau. – is CLUELESS about fake/false/forged ID’s  floating around out there…since…  In 2013, Walling testified in Columbus in favor of a bill that would require pharmacists to get a name, ID and number from the ID before handing out pills.

So if the person picking up a prescription presents a fake/forged/false ID… that serves what purpose if someone is trying to track down who is getting prescription. Who believes that a person is going to use the same fake/false/forged ID if they are doctor shopping, pharmacy shopping or forging prescriptions

DOWNTOWN CLEVELAND, OH (WOIO) –

Those who think opioids enter their neighborhoods by way of late night drug deals are likely mistaken.

Bob Walling is a drug investigator with the Westshore Enforcement Bureau. He was surprised when he took a friend’s prescription to be filled at a pharmacy. Knowing that drugs are well-tracked from manufacturer to pharmacy, he still got the prescription with no ID asked for.

“Each question they asked of me, I didn’t know and I didn’t know, and I still walked out with a prescription,” he said.

“The one exception is when it leaves the pharmacy. We don’t know exactly who takes the pill out of the pharmacy because anyone can pick up a prescription from a pharmacy for someone else,” he said of the tracking.

In 2013, Walling testified in Columbus in favor of a bill that would require pharmacists to get a name, ID and number from the ID before handing out pills.

Pharmaceutical companies got it shot down, so tracking pills remains nearly impossible. A recent case where the person who wrote a fake prescription to obtain 6,200 pills proved it.

Currently, most prescriptions are written on tamper proof paper — they all have some kind of tampering device on them. In one case there’s an RX on the
back, you can scratch it off and that tells you it’s an actual prescription.

Another challenge are doctors running lucrative pill mills.

“Doctor would ask two questions,” says Greg Mehling with the Lorain County Drug Task Force, describing a recent case. “What’s your name and what do you want, and prescriptions would be $100 each or six for $500. That’s medical prostitution — that’s not good medicine.”

These days Mehling says Percocet 10 is the drug of choice. In effect, it is clinical heroin.

In the case of opioids, the hangover is more and more often death.

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Health|Express Scripts to Offer Cheaper Drugs for Uninsured Customers         

www.nytimes.com/2017/05/08/health/express-scripts-drug-prescriptions-prices.html

It is one of the most acute indignities of being uninsured in this country: Those with the least ability to pay are asked to spend the most for their prescription drugs.

That’s because people without health insurance are forced to pay the list price for brand-name drugs, while insurers have access to a lower, negotiated rate for the same products.

On Monday, one of the biggest pharmacy benefit managers in the drug world, Express Scripts, said it would begin offering a lower rate for a select group of frequently used drugs to people without health insurance, or to those who are stuck in plans with such high deductibles they couldn’t otherwise afford their medications.

The move by Express Scripts, which has been widely criticized as one of the major drivers of rising drug costs, is particularly well timed. It comes just days after Republicans passed a health care bill that some estimate could leave millions of Americans without health insurance, and when there is considerable uncertainty among various layers of the nation’s health care industries.

Prices of medicines available from InsideRx, a subsidiary of Express Scripts. Credit Inside Rx

Timothy C. Wentworth, the chief executive of Express Scripts, said about 30 million Americans either have no insurance or high deductible plans. He said the program was not initiated with the changes to the health care law in mind, but rather to help people who are in need. “We launched this with an idea that we can get those 30 million people similar discounts to what good-sized payers get, and provide them relief,” he said in an interview.
Continue reading the main story

The program, InsideRx, is a subsidiary of Express Scripts and will work when consumers sign up for the service, which is free, and present a discount card or a mobile app to pharmacies around the country — including major chains like CVS and Walgreens, and at Kroger supermarkets — to get discounts that average around one-third off the list price. Commonly prescribed drugs, including the cholesterol treatment Crestor and some brands of insulin, are included on the list about 40 products. The program will allow Express Scripts to expand its customer base. A company spokesman said it would take a “small fee” from pharmacies for every transaction.

It is being started in partnership with GoodRx, a technology company that has been offering similar discounts on mostly generic drugs through deals it previously struck with competitors to Express Scripts.

The new program was greeted with skepticism by Ben Wakana, executive director of Patients for Affordable Drugs, a nonprofit that does not accept funding from organizations that profit from the development or distribution of prescription drugs.

“Drug prices are so high that even with a discount, medication will unfortunately be out of reach for many uninsured or underinsured Americans,” Mr. Wakana said, questioning the motives of pharmacy benefit managers such as Express Scripts, which are known as P.B.M.s. “We continue to believe the most effective way to make drugs more affordable is to bring down drug prices, not to give P.B.M.s more leverage and hope for the best.”

InsideRx members would present a card, similar to this one, in order to obtain discounts on medications. Credit Insider Rx

Adam J. Fein, a drug-distribution expert with Pembroke Consulting, noted that some of the drugs on the list, like Nexium, have similar versions that are available as prescription generics or over-the-counter drugs. Still, he said, the program “is a positive development because the system is set up to soak the poor, and this is a way to pass some of the rebates down to the point of sale.”

But the plan comes with important caveats. Patients who are covered by government programs such as Medicare and Medicaid will not be able to use it because drug companies, which helped negotiate the rates, could be seen as violating anti-kickback laws. And the payments also may not count toward a consumer’s deductible, which could end up raising costs for them in the long run.

The move could also be a way for Express Scripts to find new business. The company recently announced that its biggest customer, the insurance giant Anthem, would not renew its contract in 2020, news that sent Express Scripts stock down significantly and has raised questions about whether the company needs to change its business model. Express Scripts is the nation’s largest pharmacy benefit manager — its main business is negotiating with drug companies on behalf of insurers and large employers — but other top players are part of larger companies with other businesses. CVS Health, for example, also has a large pharmacy chain, and OptumRx, the third-largest player, is part of the health insurer UnitedHealth.

The news that Express Scripts was offering a program to help offset the high prices of prescription drugs struck some as odd, given that the company has been criticized for contributing to those high costs in the first place. Express Scripts and other benefit managers design plans that help insurers and employers reduce costs, and in recent years those companies have opted to shift much of that burden to consumers. Critics of pharmacy benefit managers have also noted that Express Scripts and others keep a slice of the rebates that are negotiated with drug companies and are based on a percentage of the list price — meaning that they make more money when drug prices go up.

Mr. Wentworth disputed the idea that Express Scripts contributes to rising drug costs and said the InsideRx plan is evidence that it is acting in consumers’ interests. “From our standpoint, we see the challenges, and that’s why we are trying to do something about it,” he said.

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https://www.securingindustry.com/pharmaceuticals/tracking-opioid-supply-chain-not-enough-to-fight-illicit-trade/s40/a4190/

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TV documentary on pain treatment funded by doctor with industry ties

www.statnews.com/2017/03/24/pain-documentary-public-television/

Public television stations across the country have begun airing a documentary about pain treatment produced by a doctor with significant financial ties to the manufacturers of opioid medications — a fact not disclosed in the program.

“The Painful Truth” chronicles the plight of several patients struggling to find effective treatment for chronic pain. Throughout the 57-minute-long program, politicians, federal agencies, and others are depicted as having overreacted to the epidemic of opioid-related overdoses; the documentary suggests pain specialists have been discouraged from prescribing opioids to patients who genuinely need them.

The program accuses the US Drug Enforcement Agency of unfairly targeting pain doctors and putting a “bounty” on pain clinics the agency aims to shut down.

“The political culture has declared war against opioids and those who prescribe them,” the narrator of the program says. “The DEA is the army. The pain patients are the civilians caught in the middle.”

The producer, Dr. Lynn Webster of Utah, and several of the experts he quotes in the program, have long-standing and extensive financial relationships with pain medicine makers. When asked why these relationships are not disclosed to viewers, Webster told STAT that he did not receive any drug industry funding for the documentary. He said it was funded entirely by himself and his wife.

“I am cognizant of that issue, but I think I dealt with it as carefully as I could,” he said in an interview. If viewers want to know whether any of the individual doctors associated with the documentary have financial relationships with pharmaceutical makers, Webster said they can search for that information on the web.

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